Drug product
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01
D-1171-2022
Product summary
- Event
- Event 90431
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36 bottles
- Official record key
drug-enforcement:D-1171-2022
Official wording
Reason: CGMP Deviations
Code information: Lot #: 20020121, Exp 01/2024
Distribution pattern: One sole distributor in TX
Derived failure modes
-
Manufacturing or process control
CGMP Deviations