Drug product
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01
D-0831-2020
Product summary
- Event
- Event 84798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 69,012 bottles
- Official record key
drug-enforcement:D-0831-2020
Official wording
Reason: GMP Deviations: Product bottle may be absent of desiccant.
Code information: Lot #: 1269726M, exp. date 01/2020; 1283269M, 1283270M, exp. date 03/2020; 1292992M,1292993A, exp. date 04/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
GMP Deviations