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Recall Observatory FDA recall evidence

Drug product

MIC/B-COMP/(M)/CHROM/CARN, 20 mg/40 mg/50 mg/25 mcg/25 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0370-2017

September 21, 2016

Class II

Product summary

Firm
Wells Pharmacy Network LLC
Event
Event 75289
Status
Terminated
Classification
Class II
Quantity
933 vials
Official record key
drug-enforcement:D-0370-2017

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: 04082016@4, 05102016@1, 05172016@6, 06032016@3, 06092016@17, 06212016@42, 07012016@32, 07272016@16, 08172016@13, 4252016@21.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility