Drug product
Desmopressin Acetate Tablets, 0.1 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 0591-2464-01
D-0830-2020
Product summary
- Event
- Event 84798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,868 bottles
- Official record key
drug-enforcement:D-0830-2020
Official wording
Reason: GMP Deviations: Product bottle may be absent of desiccant.
Code information: Lot #: 1281203M, exp. date 03/2020 and 1290113M, exp. date 04/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
GMP Deviations