Drug product
Inositol/Choline/B-Complex+Leucine+CARN+CHROM+LIDO (LipoLean), Injectable, 30 mL vial, Compounded by Wells Pharmacy. Ocala, FL
D-0363-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 433 vials
- Official record key
drug-enforcement:D-0363-2017
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: 04132016@32, 05062016@4, 05312016@5, 06132016@93, 06282016@36, 08172016@5.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility