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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

Pallimed Solutions: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Agency Publication Date: August 9, 2013
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Affected Products

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

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

All lots within expiry

Product: Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA

All lots within expiry

Product: Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

All lots within expiry

Product: Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

All lots within expiry

Product: Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MA

All lots within expiry

Product: Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

All lots within expiry

Product: Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA

All lots within expiry

Product: Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA

All lots within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 64716
Status: Resolved
Manufacturer: Pallimed Solutions
Manufactured In: United States
Units Affected: 16 products (1 vial; 408 vials; 246 vials; 71 vials; 23 vials; 7 vials; 3 vials; 261 vials; 3 vials; 18 vials; 56 vials; 2 vials; 10 vials; 597 vials; 862 vials; 12 vials)

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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 · 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.