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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

Leiter's Pharmacy: Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured. ; Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to custo

Agency Publication Date: September 13, 2013
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Affected Products

Product: Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126

Lot 06072013@49, Exp 9/5/13

Lot Numbers:
06072013
Product: Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126

Lot #: 06122013@9; Exp 9/10/13

Lot Numbers:
06122013
Product: Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126

Lot #: 08052013@1, 08052013@4, Exp 11/03/2013

Lot Numbers:
08052013
Product: Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126

Lot # : 07302013@6 Exp 10/28/13

Lot Numbers:
07302013

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 66103
Status: Resolved
Manufacturer: Leiter's Pharmacy
Manufactured In: United States
Units Affected: 4 products (56 vials; 810 vials; 265 vials; 728 vials)

Were You Affected by This Recall?

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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.