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Recall Observatory FDA recall evidence

Drug product

B-complex + Vit C 20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL

D-0342-2017

September 21, 2016

Class II

Product summary

Firm
Wells Pharmacy Network LLC
Event
Event 75289
Status
Terminated
Classification
Class II
Quantity
180 vials
Official record key
drug-enforcement:D-0342-2017

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: 03252016@2, 04292016@11, 06122016@9, 07212016@11

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility