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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 10,641–10,660 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327

by American Pharmaceutical Ingredients LLC

Reason
cGMP Deviations; lack of quality assurance.
Recall initiated
April 17, 2017
Reported by FDA
June 21, 2017
Distribution
NY, GA, NV, CA, KY, TX

View recall →

Drug Recall Ongoing Historical recordClass I

Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014

by Complete Pharmacy and Medical Solutions LLC

Reason
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
Recall initiated
April 2, 2016
Reported by FDA
June 21, 2017
Distribution
Nationwide and Puerto Rico

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Drug Recall Ongoing Historical recordClass I

Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014

by Complete Pharmacy and Medical Solutions LLC

Reason
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Recall initiated
December 29, 2015
Reported by FDA
June 21, 2017
Distribution
Distributed throughout Florida

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Drug Recall Terminated Historical recordClass II

VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC# 61553-027-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

by PharMEDium Services, LLC

Reason
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Recall initiated
February 17, 2017
Reported by FDA
June 21, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

by PharMEDium Services, LLC

Reason
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Recall initiated
February 17, 2017
Reported by FDA
June 21, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

by PharMEDium Services, LLC

Reason
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Recall initiated
February 17, 2017
Reported by FDA
June 21, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

by PharMEDium Services, LLC

Reason
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Recall initiated
February 17, 2017
Reported by FDA
June 21, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

by PharMEDium Services, LLC

Reason
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Recall initiated
February 17, 2017
Reported by FDA
June 21, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

by PharMEDium Services, LLC

Reason
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Recall initiated
February 17, 2017
Reported by FDA
June 21, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

by PharMEDium Services, LLC

Reason
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Recall initiated
February 17, 2017
Reported by FDA
June 21, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

by PharMEDium Services, LLC

Reason
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Recall initiated
February 17, 2017
Reported by FDA
June 21, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

by PharMEDium Services, LLC

Reason
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Recall initiated
February 17, 2017
Reported by FDA
June 21, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141

by PharMEDium Services, LLC

Reason
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Recall initiated
February 17, 2017
Reported by FDA
June 21, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141

by PharMEDium Services, LLC

Reason
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Recall initiated
February 17, 2017
Reported by FDA
June 21, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402

by Safecor Health, LLC

Reason
CGMP Deviations
Recall initiated
July 7, 2016
Reported by FDA
June 21, 2017
Distribution
MA and NY

View recall →

Drug Recall Terminated Historical recordClass II

Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 0143314205

by Safecor Health, LLC

Reason
CGMP Deviations
Recall initiated
July 7, 2016
Reported by FDA
June 21, 2017
Distribution
MA and NY

View recall →

Drug Recall Terminated Historical recordClass II

Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305

by Safecor Health, LLC

Reason
CGMP Deviations
Recall initiated
July 7, 2016
Reported by FDA
June 21, 2017
Distribution
MA and NY

View recall →

Drug Recall Terminated Historical recordClass II

Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392.

by Safecor Health, LLC

Reason
CGMP Deviations
Recall initiated
July 7, 2016
Reported by FDA
June 21, 2017
Distribution
MA and NY

View recall →

Drug Recall Terminated Historical recordClass II

Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009

by Safecor Health, LLC

Reason
CGMP Deviations
Recall initiated
July 7, 2016
Reported by FDA
June 21, 2017
Distribution
MA and NY

View recall →

Drug Recall Terminated Historical recordClass II

Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280.

by Safecor Health, LLC

Reason
CGMP Deviations
Recall initiated
July 7, 2016
Reported by FDA
June 21, 2017
Distribution
MA and NY

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.