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
Product summary
- 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
Lack of Assurance of Sterility