Drug product
Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-604-21; NDC Unit Dose 68084-604-11
D-0849-2020
Product summary
- Event
- Event 84990
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,720 cartons
- Official record key
drug-enforcement:D-0849-2020
Official wording
Reason: GMP Deviations: Product bottle may be absent of desiccant.
Code information: Lot 180510, exp 3/31/2020; Lot 181912, exp 4/30/2020
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
GMP Deviations