Drug product
Methylcobalamin 1,000 mcg/mL Injectable, a) 10 mL vial and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
D-0365-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 499 vials b) 1214 vials
- Official record key
drug-enforcement:D-0365-2017
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. a) Known lot code: 04062016@5, 05172016@1, 06162016@2, 07202016@47, 08222016@6 b) Known lot code: 04052016@1, 05032016@1, 05182016@1, 05262016@32, 06162016@13, 06232016@74, 07012016@18, 08092016@6, 09062016@33
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility