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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

SCA Pharmaceuticals, LLC: Various Injectable Medications Recalled for Lack of Sterility Assurance

Agency Publication Date: November 2, 2017
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Summary

SCA Pharmaceuticals is recalling 3,866 units of various injectable medications, including Succinylcholine, Hydromorphone, Fentanyl, Morphine, Oxytocin, and others, due to a lack of assurance of sterility. Using a non-sterile injectable drug can lead to serious, life-threatening infections such as sepsis or meningitis. These products were distributed nationwide in the United States to healthcare facilities in syringes, bags, and CADD cassettes.

Risk

If a drug intended for injection is not sterile, it can introduce bacteria or other contaminants directly into the bloodstream or spinal fluid. This can cause severe systemic infections, organ failure, or death, especially in hospitalized patients with weakened immune systems.

What You Should Do

  1. Identify if you have the affected medications by checking the product names and NDC numbers on the packaging. Affected items include Succinylcholine (NDC 70004-0910-29), Hydromorphone (NDCs 70004-0303-17, 70004-0331-22), Fentanyl (NDCs 70004-0231-40, 70004-0264-64), Morphine (NDCs 70004-0100-63, 70004-0100-22), Oxytocin (NDC 70004-0086-44), Phenylephrine (NDC 70004-0810-12), Calcium Gluconate (NDC 70004-0510-30), and Rocuronium Bromide (NDC 70004-850-09).
  2. Check the lot numbers and Beyond Use Dates (BUD) on your specific product: Succinylcholine lot 20170726 (BUD 10/24/2017); Hydromorphone lots 20170808 (BUD 11/06/2017), 20170816 (BUD 10/30/2017); Fentanyl lots 20170814 (BUD 11/12/2017), 20170815 (BUD 11/13/2017); Morphine lots 20170905 (BUD 12/04/2017), 20170901 (BUD 11/30/2017); Oxytocin lot 20170912 (BUD 10/22/2017); Phenylephrine lot 20170920 (BUD 12/19/2017); Calcium Gluconate lot 20170920 (BUD 11/09/2017); and Rocuronium Bromide lot 20171004 (BUD 01/09/2018).
  3. Immediately stop using any of these recalled products and quarantine them to prevent administration to patients.
  4. Contact your healthcare provider or pharmacist for guidance regarding any concerns about medication you may have received. Return any unused recalled product to the pharmacy for a refund.
  5. Contact SCA Pharmaceuticals, LLC directly at their Little Rock, AR facility to coordinate the return and replacement of affected stock.
  6. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider contact and product return.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: SUCcinylcholine 20 mg per mL (10 mL syringe)
Model:
NDC 70004-0910-29
Lot Numbers:
20170726@35
20170726
Date Ranges: BUD: 10/24/2017
Product: HYDROmorphone HCL 1 mg per mL (25 mL in 30 mL syringe)
Model:
NDC 70004-0303-17
Lot Numbers:
20170808@52
20170808
Date Ranges: BUD: 11/06/2017
Product: HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% (50 mL)
Model:
NDC 70004-0331-22
Lot Numbers:
20170816@65
20170816
Date Ranges: BUD: 10/30/2017
Product: Fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (250 mL Bag)
Model:
NDC 70004-0231-40
Lot Numbers:
20170814@20
20170814
Date Ranges: BUD: 11/12/2017
Product: FentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1% (100 mL CADD Cassette)
Model:
NDC 70004-0264-64
Lot Numbers:
20170815@26
20170815
Date Ranges: BUD: 11/13/2017
Product: Morphine sulfate 1 mg per mL (100 mL CADD Cassette)
Model:
NDC 70004-0100-63
Lot Numbers:
20170905@24
Date Ranges: BUD: 12/04/2017
Product: Morphine sulfate 1 mg per mL (50 mL Syringe)
Model:
NDC 70004-0100-22
Lot Numbers:
20170901@25
Date Ranges: BUD: 11/30/2017
Product: OxyTOCIN 30 units added to Lactated Ringers (500 mL Bag)
Model:
NDC 70004-0086-44
Lot Numbers:
20170912@13
20170912
Date Ranges: BUD: 10/22/2017
Product: PHENYLephrine HCl 100 mcg per mL (10 mL Syringe)
Model:
NDC 70004-0810-12
Lot Numbers:
20170920@53
20170920
Date Ranges: BUD: 12/19/2017
Product: Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride (50 mL Bag)
Model:
NDC 70004-0510-30
Lot Numbers:
20170920@20
20170920
Date Ranges: BUD: 11/09/2017
Product: ROCuronium Bromide 10 mg per mL (5 mL Syringe)
Model:
NDC 70004-850-09
Lot Numbers:
20171004@4
20171004
Date Ranges: BUD: 01/09/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78320
Status: Resolved
Manufacturer: SCA Pharmaceuticals, LLC
Sold By: Healthcare facilities; Hospitals
Manufactured In: United States
Units Affected: 10 products (1248 syringes; 128 syringes; 60 bags; 116 bags; 20 bags inside rigid translucent plastic cases (CADD); a) 60 bag inside rigid translucent plastic case (CADD) b) 238 bag; 450 bags; 1221 syringes; 76 bags; 487 syringes)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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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 ยท 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.