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Recall Observatory FDA recall evidence

Drug product

Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244

D-417-2013

March 28, 2013

Class II

Product summary

Firm
NuVision Pharmacy, Inc.
Event
Event 64722
Status
Terminated
Classification
Class II
Quantity
32 vials
Official record key
drug-enforcement:D-417-2013

Official wording

Reason: Lack of Assurance of Sterility; reports of adverse events after injection

Code information: Lot Number N01232013@4, Do Not Use Beyond Date of January 1, 2014

Distribution pattern: FL, MO, UT, and WA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility