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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

QuVa Pharma, Inc.: Various Fentanyl and Pain Management Drugs Recalled for Potential Glass Particles

Agency Publication Date: November 29, 2019
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Summary

QuVa Pharma, Inc. has voluntarily recalled 21 different pain management medications, including various formulations of fentanyl, bupivacaine, and ropivacaine, because they may contain microscopic glass fragments. The issue was triggered by a recall from the raw material manufacturer of the fentanyl API used to compound these drugs. These prescription medications are typically administered by healthcare professionals in hospital or surgical settings, and the affected products were distributed nationwide.

Risk

Injecting a medication that contains glass particles can cause serious health complications, such as inflammation or damage to blood vessels, granulomas (clumps of immune cells), or life-threatening blood clots that can travel to the lungs or brain. While no injuries have been reported to date, the presence of particulate matter in sterile injectable drugs poses a medium-level safety risk.

What You Should Do

  1. Check your medical supplies for any of the 21 affected products, which include fentanyl in concentrations of 2 mcg/mL, 10 mcg/mL, 20 mcg/mL, and 50 mcg/mL, often combined with Bupivacaine or Ropivacaine in bags, syringes, or CADD cartridges.
  2. Identify affected units by matching the NDC numbers and lot numbers printed on the labels; for example, check for fentanyl 500 mcg/250 mL (NDC 70092-1160-37) with lots such as 10029297 or 10031951, or fentanyl 1000 mcg/100 mL (NDC 70092-1092-36) with dozens of lots including 10029286 through 10033352.
  3. Stop using any medication that matches the recalled lot numbers and expiration dates immediately and quarantine the product to prevent accidental administration.
  4. If you are a patient who has received any of these medications and are experiencing unusual symptoms, contact your healthcare provider or physician immediately.
  5. Pharmacists and hospital administrators should contact QuVa Pharma at 1-888-723-3332 for instructions on how to return the unused product for a refund.
  6. For additional questions or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare provider notification and product return.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the place of purchase for a refund and contact QuVa Pharma at 1-888-723-3332 for specific return logistics.

Affected Products

Product: fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride (250 mL Bag)
Model:
NDC 70092-1160-37
Lot Numbers (59):
10029297 (Exp. 11/14/2019)
10029199 (Exp. 11/17/2019)
10029737 (Exp. 11/17/2019)
10029763 (Exp. 11/17/2019)
10029785 (Exp. 11/18/2019)
10029789 (Exp. 11/18/2019)
10029790 (Exp. 11/18/2019)
10029894 (Exp. 11/20/2019)
10029950 (Exp. 11/21/2019)
10030006 (Exp. 11/24/2019)
10030007 (Exp. 11/27/2019)
10030336 (Exp. 11/27/2019)
10030941 (Exp. 12/3/2019)
10030886 (Exp. 12/2/2019)
10030453 (Exp. 11/26/2019)
10030887 (Exp. 12/4/2019)
10030990 (Exp. 12/4/2019)
10030991 (Exp. 12/4/2019)
10030942 (Exp. 12/3/2019)
10030909 (Exp. 12/2/2019)
10030431 (Exp. 11/26/2019)
10030432 (Exp. 11/26/2019)
10030454 (Exp. 11/26/2019)
10031056 (Exp. 12/5/2019)
10031057 (Exp. 12/5/2019)
10031058 (Exp. 12/5/2019)
10031087 (Exp. 12/6/2019)
10031153 (Exp. 12/8/2019)
10031088 (Exp. 12/6/2019)
10031376 (Exp. 12/6/2019)
10031178 (Exp. 12/9/2019)
10031179 (Exp. 12/9/2019)
10031152 (Exp. 12/8/2019)
10031236 (Exp. 12/10/2019)
10031237 (Exp. 12/10/2019)
10031732 (Exp. 12/22/2019)
10031616 (Exp. 12/19/2019)
10031617 (Exp. 12/22/2019)
10031731 (Exp. 12/22/2019)
10031950 (Exp. 12/26/2019)
10031979 (Exp. 12/29/2019)
10031980 (Exp. 12/30/2019)
10032308 (Exp. 12/31/2019)
10032309 (Exp. 12/31/2019)
10032415 (Exp. 1/2/2020)
10032416 (Exp. 1/2/2020)
10032804 (Exp. 1/5/2020)
10032805 (Exp. 1/5/2020)
10032582 (Exp. 1/6/2020)
10032808 (Exp. 1/6/2020)
Product: fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride (250 mL Bag)
Model:
NDC 70092-1105-37
Lot Numbers (52):
10029289 (Exp. 11/14/2019)
10029841 (Exp. 11/19/2019)
10029861 (Exp. 11/19/2019)
10029863 (Exp. 11/19/2019)
10030008 (Exp. 11/24/2019)
10029946 (Exp. 11/21/2019)
10030009 (Exp. 11/24/2019)
10030010 (Exp. 11/24/2019)
10030483 (Exp. 11/27/2019)
10030482 (Exp. 11/27/2019)
10030958 (Exp. 12/3/2019)
10030908 (Exp. 12/2/2019)
10030430 (Exp. 11/26/2019)
10030989 (Exp. 12/4/2019)
10030959 (Exp. 12/3/2019)
10030907 (Exp. 12/2/2019)
10031283 (Exp. 12/11/2019)
10031345 (Exp. 12/12/2019)
10031346 (Exp. 12/12/2019)
10031477 (Exp. 12/16/2019)
10031433 (Exp. 12/15/2019)
10031434 (Exp. 12/15/2019)
10031478 (Exp. 12/16/2019)
10031568 (Exp. 12/18/2019)
10031615 (Exp. 12/19/2019)
10031479 (Exp. 12/18/2019)
10031569 (Exp. 12/18/2019)
10031570 (Exp. 12/18/2019)
10031642 (Exp. 12/20/2019)
10031591 (Exp. 12/19/2019)
10031813 (Exp. 12/23/2019)
10031814 (Exp. 12/23/2019)
10032008 (Exp. 12/27/2019)
10032009 (Exp. 12/27/2019)
10031759 (Exp. 12/26/2019)
10031946 (Exp. 12/26/2019)
10031846 (Exp. 12/24/2019)
10032250 (Exp. 12/30/2019)
10031845 (Exp. 12/24/2019)
10032366 (Exp. 1/1/2020)
10032391 (Exp. 1/1/2020)
10032333 (Exp. 12/31/2019)
10032445 (Exp. 1/2/2020)
10031760 (Exp. 1/7/2020)
10031975 (Exp. 12/29/2019)
10032533 (Exp. 1/7/2020)
10031976 (Exp. 12/29/2019)
10031977 (Exp. 12/29/2019)
10032664 (Exp. 1/8/2020)
10032665 (Exp. 1/8/2020)
Product: fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride (100 mL CADD)
Model:
NDC 70092-1259-75
Lot Numbers:
10029829 (Exp. 11/18/2019)
10029883 (Exp. 11/19/2019)
10030056 (Exp. 11/24/2019)
10030867 (Exp. 11/27/2019)
10031005 (Exp. 12/4/2019)
10030950 (Exp. 12/3/2019)
10031103 (Exp. 12/6/2019)
10031006 (Exp. 12/4/2019)
10031142 (Exp. 12/8/2019)
10031274 (Exp. 12/10/2019)
10031710 (Exp. 12/12/2019)
10031628 (Exp. 12/19/2019)
10031777 (Exp. 12/22/2019)
10031683 (Exp. 12/22/2019)
10032050 (Exp. 12/29/2019)
10032051 (Exp. 12/29/2019)
10032435 (Exp. 1/2/2020)
10032468 (Exp. 1/2/2020)
10032545 (Exp. 1/5/2020)
10032676 (Exp. 1/8/2020)
10032677 (Exp. 1/8/2020)
10032595 (Exp. 1/6/2020)
10032596 (Exp. 1/6/2020)
Product: fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride (250 mL Bag)
Model:
NDC 70092-1269-37
Lot Numbers:
10029288 (Exp. 11/14/2019)
10029762 (Exp. 11/14/2019)
10029788 (Exp. 11/18/2019)
10029838 (Exp. 11/19/2019)
10029948 (Exp. 11/21/2019)
10029949 (Exp. 11/21/2019)
10030337 (Exp. 11/24/2019)
10030539 (Exp. 11/28/2019)
10030943 (Exp. 12/3/2019)
10030964 (Exp. 12/3/2019)
10030963 (Exp. 12/3/2019)
10030888 (Exp. 12/2/2019)
10031129 (Exp. 12/8/2019)
10031284 (Exp. 12/11/2019)
10031414 (Exp. 12/15/2019)
10031435 (Exp. 12/16/2019)
10031735 (Exp. 12/22/2019)
10032253 (Exp. 12/30/2019)
10030455 (Exp. 11/26/2019)
10032535 (Exp. 1/6/2020)
10032280 (Exp. 12/31/2019)
10033009 (Exp. 1/15/2020)
10032585 (Exp. 1/14/2020)
Product: fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free (100 mL in 150 Bag)
Model:
NDC 70092-1104-36
Lot Numbers (72):
1002929 (Exp. 11/14/2019)
10029839 (Exp. 11/19/2019)
10029840 (Exp. 11/19/2019)
10029806 (Exp. 11/18/2019)
10029860 (Exp. 11/18/2019)
10030370 (Exp. 11/25/2019)
10030002 (Exp. 11/24/2019)
10030001 (Exp. 11/25/2019)
10030003 (Exp. 11/24/2019)
10030013 (Exp. 11/24/2019)
10030014 (Exp. 11/24/2019)
10030538 (Exp. 11/28/2019)
10030906 (Exp. 11/28/2019)
10030905 (Exp. 11/28/2019)
10030429 (Exp. 11/26/2019)
10031151 (Exp. 12/8/2019)
10031039 (Exp. 12/5/2019)
10031282 (Exp. 12/11/2019)
10031412 (Exp. 12/15/2019)
10031432 (Exp. 12/16/2019)
10031460 (Exp. 12/16/2019)
10031461 (Exp. 12/16/2019)
10031462 (Exp. 12/16/2019)
10031567 (Exp. 12/18/2019)
10031613 (Exp. 12/19/2019)
10031614 (Exp. 12/19/2019)
10031695 (Exp. 12/22/2019)
10031667 (Exp. 12/20/2019)
10031788 (Exp. 12/23/2019)
10031789 (Exp. 12/23/2019)
10031790 (Exp. 12/23/2019)
10031812 (Exp. 12/23/2019)
10031475 (Exp. 12/20/2019)
10031476 (Exp. 12/20/2019)
10031641 (Exp. 12/20/2019)
10031668 (Exp. 12/20/2019)
10031566 (Exp. 12/18/2019)
10031200 (Exp. 12/10/2019)
10032006 (Exp. 12/27/2019)
10032007 (Exp. 12/27/2019)
10032037 (Exp. 12/27/2019)
10032249 (Exp. 12/30/2019)
10032276 (Exp. 12/30/2019)
10031916 (Exp. 12/25/2019)
10031917 (Exp. 12/25/2019)
10031843 (Exp. 12/24/2019)
10031844 (Exp. 12/24/2019)
10031866 (Exp. 12/24/2019)
10031867 (Exp. 12/24/2019)
10032248 (Exp. 12/30/2019)
Product: fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free
Model:
NDC 70092-1099-49
Lot Numbers:
10029934 (Exp. 11/19/2019)
10029820 (Exp. 11/18/2019)
10029872 (Exp. 11/19/2019)
10029873 (Exp. 11/19/2019)
10030868 (Exp. 11/28/2019)
10030567 (Exp. 11/28/2019)
10030892 (Exp. 12/2/2019)
10030568 (Exp. 11/28/2019)
10031210 (Exp. 12/9/2019)
10031211 (Exp. 12/9/2019)
10031209 (Exp. 12/12/2019)
10031439 (Exp. 12/15/2019)
10031700 (Exp. 12/22/2019)
10031438 (Exp. 12/15/2019)
10031766 (Exp. 12/26/2019)
10032225 (Exp. 12/29/2019)
10032260 (Exp. 12/30/2019)
10032343 (Exp. 12/31/2019)
Product: fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free
Model:
NDC 70092-1225-37
Lot Numbers:
10029346 (Exp. 11/15/2019)
10029347 (Exp. 11/15/2019)
10029982 (Exp. 11/22/2019)
10030017 (Exp. 11/24/2019)
10030401 (Exp. 11/25/2019)
10031092 (Exp. 12/6/2019)
10031349 (Exp. 12/12/2019)
10032011 (Exp. 12/27/2019)
10032012 (Exp. 12/27/2019)
10032505 (Exp. 1/5/2020)
10032447 (Exp. 1/2/2020)
10032932 (Exp. 1/13/2020)
Product: fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free
Model:
NDC 70092-1093-37
Lot Numbers (97):
10029202 (Exp. 11/17/2019)
10029753 (Exp. 11/17/2019)
10029756 (Exp. 11/17/2019)
10029792 (Exp. 11/18/2019)
10029793 (Exp. 11/18/2019)
10029808 (Exp. 11/18/2019)
10029809 (Exp. 11/18/2019)
10029810 (Exp. 11/18/2019)
10029757 (Exp. 11/17/2019)
10029758 (Exp. 11/17/2019)
10029920 (Exp. 11/19/2019)
10029897 (Exp. 11/20/2019)
10030394 (Exp. 11/25/2019)
10030395 (Exp. 11/25/2019)
10030479 (Exp. 11/27/2019)
10030480 (Exp. 11/27/2019)
10030481 (Exp. 11/27/2019)
10030449 (Exp. 11/26/2019)
10030450 (Exp. 11/26/2019)
10030451 (Exp. 11/26/2019)
10030883 (Exp. 12/2/2019)
10030885 (Exp. 12/2/2019)
10030507 (Exp. 11/27/2019)
10030508 (Exp. 11/27/2019)
10030936 (Exp. 12/3/2019)
10030937 (Exp. 12/3/2019)
10030956 (Exp. 12/3/2019)
10030903 (Exp. 11/30/2019)
10030904 (Exp. 11/30/2019)
10030988 (Exp. 12/4/2019)
10030938 (Exp. 12/3/2019)
10030955 (Exp. 12/3/2019)
10030884 (Exp. 11/30/2019)
10030902 (Exp. 11/30/2019)
10030986 (Exp. 12/4/2019)
10030987 (Exp. 12/4/2019)
10031009 (Exp. 12/4/2019)
10031127 (Exp. 12/8/2019)
10031128 (Exp. 12/8/2019)
10031150 (Exp. 12/8/2019)
10030506 (Exp. 11/27/2019)
10030448 (Exp. 11/26/2019)
10031176 (Exp. 12/9/2019)
10031385 (Exp. 12/9/2019)
10031149 (Exp. 12/8/2019)
10031234 (Exp. 12/10/2019)
10031235 (Exp. 12/10/2019)
10031259 (Exp. 12/10/2019)
10031261 (Exp. 12/10/2019)
10031177 (Exp. 12/9/2019)
Product: fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chloride (200 mL CADD Preservative Free)
Model:
NDC 70092-1440-76
Lot Numbers:
10029307 (Exp. 11/14/2019)
10029939 (Exp. 11/20/2019)
10029884 (Exp. 11/19/2019)
10029915 (Exp. 11/20/2019)
10030385 (Exp. 11/25/2019)
10030386 (Exp. 11/25/2019)
10030923 (Exp. 12/11/2019)
10031320 (Exp. 12/11/2019)
10031025 (Exp. 12/12/2019)
10031024 (Exp. 12/12/2019)
10032678 (Exp. 1/8/2020)
10032993 (Exp. 1/14/2020)
Product: fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free
Model:
NDC 70092-1092-36
Lot Numbers (88):
10029286 (Exp. 11/14/2019)
10029287 (Exp. 11/14/2019)
10029761 (Exp. 11/14/2019)
10029764 (Exp. 11/14/2019)
10029754 (Exp. 11/17/2019)
10029787 (Exp. 11/17/2019)
10029862 (Exp. 11/18/2019)
10029892 (Exp. 11/20/2019)
10029893 (Exp. 11/20/2019)
10030011 (Exp. 11/24/2019)
10030012 (Exp. 11/24/2019)
10030018 (Exp. 11/24/2019)
10029947 (Exp. 11/21/2019)
10029951 (Exp. 11/21/2019)
10030346 (Exp. 11/24/2019)
10030345 (Exp. 11/24/2019)
10030880 (Exp. 12/2/2019)
10030882 (Exp. 12/2/2019)
10030983 (Exp. 12/4/2019)
10030985 (Exp. 12/4/2019)
10030933 (Exp. 12/3/2019)
10030934 (Exp. 12/3/2019)
10030935 (Exp. 12/3/2019)
10030881 (Exp. 12/2/2019)
10030982 (Exp. 12/4/2019)
10030984 (Exp. 12/4/2019)
10031035 (Exp. 12/5/2019)
10031036 (Exp. 12/5/2019)
10031037 (Exp. 12/5/2019)
10031038 (Exp. 12/5/2019)
10031175 (Exp. 12/9/2019)
10031198 (Exp. 12/10/2019)
10031199 (Exp. 12/10/2019)
10031232 (Exp. 12/10/2019)
10031242 (Exp. 12/10/2019)
10031386 (Exp. 12/10/2019)
10031174 (Exp. 12/9/2019)
10030424 (Exp. 11/26/2019)
10030425 (Exp. 11/26/2019)
10031233 (Exp. 12/10/2019)
10031459 (Exp. 12/16/2019)
10031526 (Exp. 12/16/2019)
10031410 (Exp. 12/15/2019)
10031431 (Exp. 12/15/2019)
10031458 (Exp. 12/16/2019)
10031525 (Exp. 12/16/2019)
10031608 (Exp. 12/19/2019)
10031664 (Exp. 12/20/2019)
10031609 (Exp. 12/19/2019)
10031663 (Exp. 12/20/2019)
Product: fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free
Model:
NDC 70092-1097-43
Lot Numbers:
10029772 (Exp. 11/17/2019)
10030627 (Exp. 11/22/2019)
10030626 (Exp. 11/21/2019)
10030408 (Exp. 11/25/2019)
10030512 (Exp. 11/27/2019)
10031107 (Exp. 12/5/2019)
10031268 (Exp. 12/10/2019)
10031437 (Exp. 12/15/2019)
10031821 (Exp. 12/23/2019)
10032285 (Exp. 12/30/2019)
Product: fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride (100 mL CADD Preservative Free)
Model:
NDC 70092-1202-75
Lot Numbers:
10029306 (Exp. 11/14/2019)
10029881 (Exp. 11/18/2019)
10029748 (Exp. 11/17/2019)
10029882 (Exp. 11/18/2019)
10029854 (Exp. 11/19/2019)
10030947 (Exp. 12/3/2019)
10030894 (Exp. 12/2/2019)
10030442 (Exp. 11/26/2019)
10031295 (Exp. 12/11/2019)
10031319 (Exp. 12/11/2019)
10031518 (Exp. 12/17/2019)
10031553 (Exp. 12/17/2019)
10031468 (Exp. 12/16/2019)
10032703 (Exp. 1/8/2020)
10032594 (Exp. 1/6/2020)
10032543 (Exp. 1/5/2020)
10031906 (Exp. 12/25/2019)
10031882 (Exp. 12/24/2019)
10031802 (Exp. 12/23/2019)
10031775 (Exp. 12/22/2019)
10031582 (Exp. 12/18/2019)
10032673 (Exp. 1/8/2020)
10032021 (Exp. 12/27/2019)
10031960 (Exp. 12/26/2019)
10032405 (Exp. 1/1/2020)
10032380 (Exp. 1/1/2020)
Product: fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe Preservative Free
Model:
NDC 70092-1100-50
Lot Numbers:
10029773 (Exp. 11/17/2019)
10029821 (Exp. 11/18/2019)
10030351 (Exp. 11/21/2019)
10031014 (Exp. 12/2/2019)
10030912 (Exp. 12/2/2019)
10030569 (Exp. 11/28/2019)
10030966 (Exp. 12/3/2019)
10031796 (Exp. 12/23/2019)
10031509 (Exp. 12/17/2019)
10031067 (Exp. 12/5/2019)
10031156 (Exp. 12/16/2019)
Product: fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride (100 mL CADD Preservative Free)
Model:
NDC 70092-1255-75
Lot Numbers:
10029914 (Exp. 11/20/2019)
10030342 (Exp. 11/24/2019)
10030948 (Exp. 12/3/2019)
10030895 (Exp. 12/2/2019)
10030949 (Exp. 12/3/2019)
10031377 (Exp. 12/6/2019)
10031141 (Exp. 12/9/2019)
10031423 (Exp. 12/15/2019)
10031627 (Exp. 12/19/2019)
10031709 (Exp. 12/22/2019)
10031907 (Exp. 12/25/2019)
10032022 (Exp. 12/27/2019)
10031858 (Exp. 12/24/2019)
10032381 (Exp. 1/1/2020)
10032296 (Exp. 12/31/2019)
10032268 (Exp. 12/30/2019)
10032467 (Exp. 1/2/2020)
10032674 (Exp. 1/8/2020)
10032569 (Exp. 1/6/2020)
10032570 (Exp. 1/6/2020)
10032516 (Exp. 1/5/2020)
10032517 (Exp. 1/5/2020)
10032675 (Exp. 1/8/2020)
10033019 (Exp. 1/15/2020)
Product: fentaNYL 250 mcg/5 mL (50 mcg/mL) 5 mL Syringe Preservative Free
Model:
NDC 70092-1098-44
Lot Numbers:
10030458 (Exp. 11/26/2019)
10031113 (Exp. 12/5/2019)
10031305 (Exp. 12/11/2019)
10031417 (Exp. 12/15/2019)
10031765 (Exp. 12/26/2019)
10032259 (Exp. 12/30/2019)
Product: fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride (100 mL Bag Preservative Free)
Model:
NDC 70092-1108-36
Lot Numbers:
10029291 (Exp. 11/14/2019)
10029292 (Exp. 11/14/2019)
10029977 (Exp. 11/20/2019)
10030041 (Exp. 11/21/2019)
10029978 (Exp. 11/21/2019)
10029979 (Exp. 11/21/2019)
10030043 (Exp. 11/21/2019)
10030396 (Exp. 11/25/2019)
10030960 (Exp. 12/2/2019)
10030961 (Exp. 12/4/2019)
10030962 (Exp. 12/4/2019)
10031010 (Exp. 12/4/2019)
10031011 (Exp. 12/4/2019)
10031012 (Exp. 12/4/2019)
10031086 (Exp. 12/6/2019)
10031263 (Exp. 12/10/2019)
10031262 (Exp. 12/10/2019)
10031413 (Exp. 12/15/2019)
10031463 (Exp. 12/16/2019)
10031696 (Exp. 12/22/2019)
10031947 (Exp. 12/26/2019)
10031948 (Exp. 12/31/2019)
10032414 (Exp. 1/2/2020)
10031978 (Exp. 1/1/2020)
10032412 (Exp. 1/2/2020)
10032413 (Exp. 1/2/2020)
10032687 (Exp. 1/8/2020)
10032723 (Exp. 1/9/2020)
10033037 (Exp. 1/23/2020)
10032929 (Exp. 1/26/2020)
Product: fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride (200 mL Bag Preservative Free)
Model:
NDC 70092-1207-37
Lot Numbers:
10029343 (Exp. 11/15/2019)
10029344 (Exp. 11/15/2019)
10029345 (Exp. 11/15/2019)
10029895 (Exp. 11/20/2019)
10029918 (Exp. 11/20/2019)
10029919 (Exp. 11/20/2019)
10030398 (Exp. 11/25/2019)
10030399 (Exp. 11/25/2019)
10030400 (Exp. 11/25/2019)
10031089 (Exp. 12/6/2019)
10031059 (Exp. 12/5/2019)
10031060 (Exp. 12/5/2019)
10031061 (Exp. 12/5/2019)
10031326 (Exp. 12/12/2019)
10031327 (Exp. 12/12/2019)
10031507 (Exp. 12/17/2019)
10031480 (Exp. 12/19/2019)
10031618 (Exp. 12/19/2019)
10031619 (Exp. 12/19/2019)
10031672 (Exp. 12/20/2019)
10031504 (Exp. 12/18/2019)
10031733 (Exp. 12/22/2019)
10031734 (Exp. 12/22/2019)
10031815 (Exp. 12/23/2019)
10031505 (Exp. 12/18/2019)
10031506 (Exp. 12/17/2019)
10031328 (Exp. 12/12/2019)
10031816 (Exp. 12/23/2019)
10031897 (Exp. 12/25/2019)
10031919 (Exp. 12/25/2019)
10031847 (Exp. 12/24/2019)
10031791 (Exp. 12/23/2019)
10031792 (Exp. 12/23/2019)
10031793 (Exp. 12/23/2019)
10031817 (Exp. 12/23/2019)
10032279 (Exp. 12/31/2019)
10032334 (Exp. 12/31/2019)
10032368 (Exp. 1/1/2020)
10032392 (Exp. 1/1/2020)
10032278 (Exp. 12/31/2019)
10032251 (Exp. 12/30/2019)
10032252 (Exp. 12/30/2019)
10032930 (Exp. 1/13/2020)
10032850 (Exp. 1/12/2020)
10032584 (Exp. 1/6/2020)
10032900 (Exp. 1/13/2020)
10032583 (Exp. 1/7/2020)
10032901 (Exp. 1/13/2020)
10032931 (Exp. 1/16/2020)
Product: fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride (100 mL Bag Preservative Free)
Model:
NDC 70092-1094-36
Lot Numbers:
10029201 (Exp. 11/17/2019)
10029983 (Exp. 11/22/2019)
10029987 (Exp. 11/22/2019)
10030428 (Exp. 11/26/2019)
10030879 (Exp. 11/28/2019)
10031240 (Exp. 12/10/2019)
10031241 (Exp. 12/10/2019)
10031344 (Exp. 12/12/2019)
10031343 (Exp. 12/12/2019)
10031394 (Exp. 12/12/2019)
10031612 (Exp. 12/19/2019)
10031665 (Exp. 12/20/2019)
10031666 (Exp. 12/20/2019)
10031590 (Exp. 12/18/2019)
10031787 (Exp. 12/23/2019)
10032036 (Exp. 12/27/2019)
10032305 (Exp. 12/31/2019)
10032444 (Exp. 1/2/2020)
10033172 (Exp. 1/12/2020)
Product: fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride (200 mL CADD Preservative Free)
Model:
NDC 70092-1441-76
Lot Numbers:
10029361 (Exp. 11/15/2019)
10029362 (Exp. 11/15/2019)
10029334 (Exp. 11/14/2019)
10029855 (Exp. 11/19/2019)
10029856 (Exp. 11/19/2019)
10030387 (Exp. 11/25/2019)
10030388 (Exp. 11/25/2019)
10031026 (Exp. 12/12/2019)
10031078 (Exp. 12/12/2019)
10031469 (Exp. 12/16/2019)
10031493 (Exp. 12/16/2019)
10031519 (Exp. 12/17/2019)
10031804 (Exp. 12/23/2019)
10031105 (Exp. 12/12/2019)
10031830 (Exp. 12/23/2019)
10031884 (Exp. 12/24/2019)
10032704 (Exp. 1/8/2020)
10032888 (Exp. 1/12/2020)
10032889 (Exp. 1/12/2020)
10032913 (Exp. 1/13/2020)
10032939 (Exp. 1/13/2020)
10032940 (Exp. 1/13/2020)
Product: fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Free (100 mL in 150 mL Bag)
Model:
NDC 70092-1103-36
Lot Numbers:
10029200 (Exp. 11/18/2019)
10030347 (Exp. 11/24/2019)
10031325 (Exp. 12/16/2019)
10030939 (Exp. 12/3/2019)
10031865 (Exp. 12/24/2019)
10031758 (Exp. 12/26/2019)
10031757 (Exp. 12/26/2019)
10032275 (Exp. 12/30/2019)
Product: fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free
Model:
NDC 70092-1415-47
Lot Numbers:
10030359 (Exp. 11/21/2019)
10030549 (Exp. 11/28/2019)
10031169 (Exp. 12/8/2019)
10031491 (Exp. 12/16/2019)
10031879 (Exp. 12/24/2019)
10032317 (Exp. 12/31/2019)
10032265 (Exp. 12/30/2019)
Product: fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free
Model:
NDC 70092-1444-05
Lot Numbers:
10029186 (Exp. 11/18/2019)
10029791 (Exp. 11/18/2019)
10030403 (Exp. 11/25/2019)
10030456 (Exp. 11/27/2019)
10030910 (Exp. 12/2/2019)
10031154 (Exp. 12/8/2019)
10031238 (Exp. 12/10/2019)
10031182 (Exp. 12/9/2019)
10031130 (Exp. 12/8/2019)
10031483 (Exp. 12/16/2019)
10031482 (Exp. 12/16/2019)
10031621 (Exp. 12/19/2019)
10031592 (Exp. 12/19/2019)
10031921 (Exp. 12/25/2019)
10031869 (Exp. 12/24/2019)
10032219 (Exp. 12/29/2019)
10032393 (Exp. 1/1/2020)
10032369 (Exp. 1/1/2020)
10032561 (Exp. 1/6/2020)
10032586 (Exp. 1/6/2020)
10031898 (Exp. 12/26/2019)
Product: fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride (200 mL in 250 mL CADD Preservative Free)
Model:
NDC 70092-1436-76
Lot Numbers:
10029972 (Exp. 11/21/2019)
10030562 (Exp. 11/28/2019)
10031447 (Exp. 12/15/2019)
10031341 (Exp. 12/15/2019)
10031630 (Exp. 12/19/2019)
10031748 (Exp. 12/22/2019)
10032817 (Exp. 1/8/2020)
10033208 (Exp. 1/19/2020)
10032887 (Exp. 1/12/2020)
Product: fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL Bag Preservative Free
Model:
NDC 70092-1436-76
Lot Numbers:
10030890 (Exp. 12/2/2019)
10031264 (Exp. 12/10/2019)
10031093 (Exp. 12/6/2019)
10032337 (Exp. 12/31/2019)
Product: fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free
Model:
NDC 70092-1180-79
Lot Numbers:
10030060 (Exp. 11/21/2019)
10030574 (Exp. 11/28/2019)
10031353 (Exp. 12/12/2019)
10031677 (Exp. 12/20/2019)
10031622 (Exp. 12/19/2019)
10031419 (Exp. 12/15/2019)
10031769 (Exp. 12/26/2019)
10031826 (Exp. 12/23/2019)
10032287 (Exp. 12/30/2019)
Product: fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride (100 mL CADD Preservative Free)
Model:
NDC 70092-1250-75
Lot Numbers:
10030341 (Exp. 11/24/2019)
10031102 (Exp. 12/6/2019)
10031555 (Exp. 12/18/2019)
10031554 (Exp. 12/18/2019)
10031803 (Exp. 12/23/2019)
10031776 (Exp. 12/22/2019)
10032266 (Exp. 12/30/2019)
10032267 (Exp. 12/30/2019)
10032321 (Exp. 12/31/2019)
10032320 (Exp. 12/31/2019)
10032544 (Exp. 1/5/2020)
10032515 (Exp. 1/5/2020)
Product: fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free
Model:
NDC 70092-1274-50
Lot Numbers:
10031855 (Exp. 12/24/2019)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84263
Status: Resolved
Manufacturer: QuVa Pharma, Inc.
Sold By: hospitals; surgical centers; clinics
Manufactured In: United States
Distributed To: Nationwide
Agency Last Updated: December 4, 2019

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.