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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 16,781–16,800 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Quadmix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Nandrolone Decanoate Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

MIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Diazepam Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Cidofovir Opthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Buprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Bacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA

by Pallimed Solutions

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
March 25, 2013
Reported by FDA
August 21, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01

by American Health Packaging

Reason
Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.
Recall initiated
May 21, 2013
Reported by FDA
August 14, 2013
Distribution
Nationwide.

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.