Skip to content
Recall Observatory FDA recall evidence

Drug product

MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

D-0368-2017

September 21, 2016

Class II

Product summary

Firm
Wells Pharmacy Network LLC
Event
Event 75289
Status
Terminated
Classification
Class II
Quantity
633 vials
Official record key
drug-enforcement:D-0368-2017

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: 04222016@4, 05112016@24, 05162016@14, 06082016@8, 06222016@42, 07272016@8

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility