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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

KRS Global Biotechnology, Inc: Various Sterile Injectable Medications Recalled for Lack of Sterility Assurance

Agency Publication Date: October 1, 2019
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Summary

KRS Global Biotechnology, Inc. is recalling 223,330 units of various sterile injectable medications, including Alpha Lipoic Acid, Ascorbic Acid, Fentanyl Citrate, and Ketamine, due to a lack of assurance of sterility. Using products that are not properly sterilized can lead to life-threatening infections, particularly since these medications are administered through IV, injection, or in the eye. These prescription-only medications were distributed nationwide to healthcare facilities and clinics.

Risk

The lack of sterility assurance means the medications may be contaminated with microorganisms. If an unsterile product is injected into the body or eyes, it can cause severe systemic infections, inflammation, or other serious health complications.

What You Should Do

  1. Check your medical supplies for any injectable products from KRS Global Biotechnology, Inc., including vials, syringes, IV bags, and droptainers.
  2. Identify affected products by checking for specific NDC numbers and ensuring the product is still within its expiration date. This recall includes all lots remaining within expiry for 80 different drug products.
  3. Immediately stop using any affected medications and quarantine the product to ensure it is not administered to patients.
  4. Contact your healthcare provider or pharmacist immediately if you have received any of these medications and are concerned about your health or experiencing unusual symptoms.
  5. Return any unused product to the place of purchase or follow the instructions provided by KRS Global Biotechnology for returning the recalled items.
  6. For questions regarding this recall, contact your healthcare provider, pharmacist, or 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 guidance and pharmacist refund

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

Affected Products

Product: Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial
Model:
NDC 3321674205
Lot Numbers:
All lots remaining within expiry
Product: Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial
Model:
NDC 3321675412
Lot Numbers:
All lots remaining within expiry
Product: Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial (Contains Sulfites)
Model:
NDC 3321675033
Lot Numbers:
All lots remaining within expiry
Product: Bacteriostatic Water for Injection, 30 mL Vial
Model:
NDC 3321674177
Lot Numbers:
All lots remaining within expiry
Product: Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial
Model:
NDC 3321676500
Lot Numbers:
All lots remaining within expiry
Product: L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL)
Model:
NDC 3321674166
Lot Numbers:
All lots remaining within expiry
Product: L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL)
Model:
NDC 3321676396
Lot Numbers:
All lots remaining within expiry
Product: ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL in 6 mL Syringe
Model:
NDC 3321678375
Lot Numbers:
All lots remaining within expiry
Product: ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL in 6 mL Syringe
Model:
NDC 3321678374
Lot Numbers:
All lots remaining within expiry
Product: ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL in 12 mL Syringe
Model:
NDC 3321678373
Lot Numbers:
All lots remaining within expiry
Product: fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL IV Bag
Model:
NDC 33216282300
Lot Numbers:
All lots remaining within expiry
Product: fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 100 mL IV Bag
Model:
NDC 33216286300
Lot Numbers:
All lots remaining within expiry
Product: fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL IV Bag
Model:
NDC 33216286000
Lot Numbers:
All lots remaining within expiry
Product: Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial
Model:
NDC 3321676632
Lot Numbers:
All lots remaining within expiry
Product: Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL)
Model:
NDC3321674186
Lot Numbers:
All lots remaining within expiry
Product: GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe
Model:
NDC3321678316
Lot Numbers:
All lots remaining within expiry
Product: GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe
Model:
NDC03321678317
Lot Numbers:
All lots remaining within expiry
Product: Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized
Model:
NDC 3321673974
Lot Numbers:
All lots remaining within expiry
Product: Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized
Model:
NDC 3321673977
Lot Numbers:
All lots remaining within expiry
Product: Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized
Model:
NDC03321673964
Lot Numbers:
All lots remaining within expiry
Product: Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized
Model:
NDC 3321673969
Lot Numbers:
All lots remaining within expiry
Product: Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL in 5 mL Vial
Model:
NDC 3321678359
Lot Numbers:
All lots remaining within expiry
Product: Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use
Model:
NDC 3321678336
Lot Numbers:
All lots remaining within expiry
Product: Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial
Model:
NDC 3321678337
Lot Numbers:
All lots remaining within expiry
Product: Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use
Model:
NDC 3321678334
Lot Numbers:
All lots remaining within expiry
Product: Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe
Model:
NDC 33216077967
Lot Numbers:
All lots remaining within expiry
Product: Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL in 6 mL Syringe
Model:
NDC 3321678093
Lot Numbers:
All lots remaining within expiry
Product: Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe
Model:
NDC 3321676419
Lot Numbers:
All lots remaining within expiry
Product: LIDOcaine HCl 0.75%/EPINRPHrine 0.025% (PF) (Sulfite Free) in BSS, 1 mL in 3 mL Syringe
Model:
NDC 3321678395
Lot Numbers:
All lots remaining within expiry
Product: LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe
Model:
NDC 3321678424
Lot Numbers:
All lots remaining within expiry
Product: LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe
Model:
NDC 3321678315
Lot Numbers:
All lots remaining within expiry
Product: Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL in 6 mL Syringe
Model:
NDC 3321678368
Lot Numbers:
All lots remaining within expiry
Product: LIDOcaine 2%/Bupivacaine 0.375%/Hyaluronidase 3 U/mL (PF) Ophthalmic Injection, 5 mL in 6 mL Syringe
Model:
NDC 3321678362
Lot Numbers:
All lots remaining within expiry
Product: Methionine/Inositol/Choline Chloride/Pyridoxine HCl/Cyanocobalamin Lyophilized Vial
Model:
NDC 3321675952
Lot Numbers:
All lots remaining within expiry
Product: Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL)
Model:
NDC 3321674232
Lot Numbers:
All lots remaining within expiry
Product: Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF) 10 mL Vial
Model:
NDC 3321678355
Lot Numbers:
All lots remaining within expiry
Product: Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL in 1 mL Syringe
Model:
NDC 3321678126
Lot Numbers:
All lots remaining within expiry
Product: Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL in 1 mL Syringe
Model:
NDC 3321678320
Lot Numbers:
All lots remaining within expiry
Product: NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe
Model:
NDC 3321677847
Lot Numbers:
All lots remaining within expiry
Product: NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL in 6 mL Syringe
Model:
NDC 3321678303
Lot Numbers:
All lots remaining within expiry
Product: Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vial, 500 mg/Vial
Model:
NDC 3321678103
Lot Numbers:
All lots remaining within expiry
Product: NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL
Model:
NDC 3321678032
Lot Numbers:
All lots remaining within expiry
Product: NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL
Model:
NDC 3321678406
Lot Numbers:
All lots remaining within expiry
Product: Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL
Model:
NDC 3321678217
Lot Numbers:
All lots remaining within expiry
Product: OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL IV Bag
Model:
NDC 3321676819
Lot Numbers:
All lots remaining within expiry
Product: Phenylephrine HCl 1.5%/Lidocaine HCl 1% (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Syringe
Model:
NDC 3321678441
Lot Numbers:
All lots remaining within expiry
Product: PHENYLephrine HCl 1.5%/LIDOcaine 1% (PF) (Sulfite Free) Ophthalmic Injection, 3 mL in 5 mL Syringe
Model:
NDC 3321678170
Lot Numbers:
All lots remaining within expiry
Product: PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL) 10 mL in 12 mL Syringe
Model:
NDC 3321677379
Lot Numbers:
All lots remaining within expiry
Product: PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL Bag
Model:
NDC 3321678039
Lot Numbers:
All lots remaining within expiry
Product: PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL Bag
Model:
NDC 3321677861
Lot Numbers:
All lots remaining within expiry
Product: PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 30 mg/250 mL Bag
Model:
NDC 3321678401
Lot Numbers:
All lots remaining within expiry
Product: Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use
Model:
NDC 3321677749
Lot Numbers:
All lots remaining within expiry
Product: Quadmix #13A (Prostaglandin E1/Papaverine HCl/Phentolamine Mesylate/Atropine Sulfate) Vial
Model:
NDC 3321678398
Lot Numbers:
All lots remaining within expiry
Product: Quadmix # 19 (Prostaglandin E1/Papaverine HCl/Phentolamine Mesylate/Atropine Sulfate) Vial
Model:
NDC 3321678383
Lot Numbers:
All lots remaining within expiry
Product: Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use
Model:
NDC 3321674047
Lot Numbers:
All lots remaining within expiry
Product: Sermorelin Acetate, 3 mg/mL/GHRP6/GHRP2, 3 mL Injection Cartridges
Model:
Item#: 73752
Lot Numbers:
All lots remaining within expiry
Product: Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial Lyophilized
Model:
NDC 3321673816
Lot Numbers:
All lots remaining within expiry
Product: Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial Lyophilized
Model:
NDC 3321673589
Lot Numbers:
All lots remaining within expiry
Product: Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL) Cartridges
Lot Numbers:
All lots remaining within expiry
Product: Sermorelin Acetate 3 mg / Vial Lyophilized
Model:
NDC 3321601122
Lot Numbers:
All lots remaining within expiry
Product: Sermorelin Acetate 9 mg / Vial Lyophilized
Model:
NDC 3321673588
Lot Numbers:
All lots remaining within expiry
Product: Sermorelin, 3 mg / GHRP-2, 3 mg / Vial Lyophilized
Model:
NDC 3321674092
Lot Numbers:
All lots remaining within expiry
Product: Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL in 60 mL Single Dose Syringe
Model:
NDC 3321674199
Lot Numbers:
All lots remaining within expiry
Product: Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial
Model:
NDC 3321676603
Lot Numbers:
All lots remaining within expiry
Product: SUCCinylcholine Chloride (PF), 100 mg / 5 mL in 6 mL Single Dose Syringe
Model:
NDC 3321678418
Lot Numbers:
All lots remaining within expiry
Product: SUCCinylcholine Chloride (PF), 140 mg/7 mL in 12 mL Single Dose Syringe
Model:
NDC 3321678417
Lot Numbers:
All lots remaining within expiry
Product: SUCCinylcholine Chloride (PF), 200 mg/10 mL in 12 mL Single Dose Syringe
Model:
NDC 3321678416
Lot Numbers:
All lots remaining within expiry
Product: Cyclopentolate HCl/Phenylephrine HCl/Tropicamide/Ketorolac Tromethamine 0.5 mL in 3 mL Syringe
Model:
NDC 3321677510
Lot Numbers:
All lots remaining within expiry
Product: Cyclopentolate HCl/Phenylephrine HCl/Tropicamide Ophthalmic Solution 5 mL Droptainer
Model:
NDC 3321678092
Lot Numbers:
All lots remaining within expiry
Product: Cyclopentolate HCl/Phenylephrine HCl/Tropicamide/Ketorolac Tromethamine 3 mL Droptainer
Model:
NDC 3321676225
Lot Numbers:
All lots remaining within expiry
Product: Cyclopentolate HCl/Phenylephrine HCl/Tropicamide 0.5 mL in 3 mL Syringe (Contains Sulfites)
Model:
NDC 3321677124
Lot Numbers:
All lots remaining within expiry
Product: Vitamin 10 B Lyophilized Vial
Model:
NDC3321678338
Lot Numbers:
All lots remaining within expiry
Product: Vitamin 10 D Lyophilized Vial
Model:
NDC 3321678341
Lot Numbers:
All lots remaining within expiry
Product: Vitamin 5 B, 30 mL Vial
Model:
NDC 3321674253
Lot Numbers:
All lots remaining within expiry
Product: Vitamin 9 Lyophilized Vial
Model:
NDC 3321674147
Lot Numbers:
All lots remaining within expiry
Product: Vitamin 9A/B Lyophilized Vial
Model:
NDC 3321678339
Lot Numbers:
All lots remaining within expiry
Product: Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN (PF) 3 mL in 5 mL Vial
Model:
NDC 3321678335
Lot Numbers:
All lots remaining within expiry
Product: Cyclopentolate HCl/Phenylephrine HCl/Tropicamide/Ketorolac Tromethamine 5 mL Droptainer
Model:
NDC 3321676223
Lot Numbers:
All lots remaining within expiry
Product: L-Asparaginase Lyophilized, 10,000 International Units/Vial
Model:
NDC 3321674499
Lot Numbers:
All lots remaining within expiry
Product: Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL IV Bag (Contains Sulfites)
Model:
NDC 3321677610
Lot Numbers:
All lots remaining within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83789
Status: Resolved
Manufacturer: KRS Global Biotechnology, Inc
Sold By: Hospitals; Clinics; Healthcare facilities; Healthcare practitioners
Manufactured In: United States
Units Affected: 78 products (77 vials; 2219 vials; 602 vials; 6568 vials; 162 vials; 10014 vials; 6447 vials; 3895 syringes; 12445 syringes; 16585 syringes; 492 bags; 934 bags; 1882 bags; 1980 vials; 402 vials; 10630 syringes; 2625 syringes; 6620 vials; 1871 vials; 2219 vials; 2263 vials; 928 vials; 1528; 345 vials; 345 vials; 1044 syringes; 11733 syringes; 6405 syringes; 4105 syringes; 2565 syringes; 4450 syringes; 2615 syringes; 2255 syringes; 497 vials; 1189 vials; 878 vials; 1290 syringes; 9920 syringes; 7685 syringes; 3410 syringes; 4390 vials; 528 bags; 1464 bags; 2760 bags; 4497 bags; 825 syringe; 3150 vials; 15260 syringes; 228 bags; 708 bags; 60 bags; 317 vials; 91 vials; 95 vials; 258 vials; 218 cartridges; 647 vials; 246 vials; 152 cartridges; 64 vials; 341 vials; 120 vials; 540 syringes; 150 vials; 7905 syringes; 1350 syringes; 3820 syringes; 1815 syringes; 242 droptainers; 649 droptainers; 465 syringes; 6747 vials; 508 vials; 616 vials; 470 vials; 6325 vials; 948 vials; 242 droptainers)
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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.