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Recall Observatory FDA recall evidence

Drug product

Glutamine/Arginine/Carnitine 25 mg/100 mg/200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0359-2017

September 21, 2016

Class II

Product summary

Firm
Wells Pharmacy Network LLC
Event
Event 75289
Status
Terminated
Classification
Class II
Quantity
137 vials
Official record key
drug-enforcement:D-0359-2017

Official wording

Reason: Lack of Assurance of Sterility

Code information: All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07012016@10, 08032016@42, 08182016@11.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility