Drug product
Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05
D-0866-2023
Product summary
- Firm
- Viatris Inc
- Event
- Event 92366
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,736 boxes
- Official record key
drug-enforcement:D-0866-2023
Official wording
Reason: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Code information: Lot #: 101241A, Exp 10/23
Distribution pattern: Product was distributed to 10 distributors who may have further distribute the product to the retail level.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations