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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 2,681–2,700 of 18,047 drug recalls

Drug Recall Terminated Historical recordClass II

Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories

by Amerisource Health Services LLC

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
March 17, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories

by Amerisource Health Services LLC

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
March 17, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass III

Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Pharamceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1574-01.

by Amneal Pharmaceuticals of New York, LLC

Reason
Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
Recall initiated
May 8, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA and PR

View recall →

Drug Recall Terminated Historical recordClass II

HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-2, code 7128580942.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8091-1, code 7128580911.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8078-1, code 7128580781.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8077-1, code 7128580771.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8029-1, code 7128580291.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9002-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9001-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9000-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

heparin added to 0.9% sodium chloride, 2,500 units/500 mL* (5 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8100-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

NORepinephrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8097-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

NORepinephrine added to 0.9% sodium chloride, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8096-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

NORepinephrine added to dextrose 5%, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8095-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

EPINEPHrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8093-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8086-2.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8069-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

heparin added to 0.9% sodium chloride, 2,500 units/250 mL* (10 units/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8000-1.

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated
April 28, 2023
Reported by FDA
May 31, 2023
Distribution
Nationwide in the USA.

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.

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