Drug product
Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10
D-1128-2017
Product summary
- Event
- Event 78020
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3966 unit-dose boxes
- Official record key
drug-enforcement:D-1128-2017
Official wording
Reason: Failed moisture limits: Out of specification for moisture content.
Code information: Lot#: 0112313 Exp. 12/2017; 0113376 Exp. 06/2018; 0113645 Exp. 02/2019.
Distribution pattern: PA, OH, IL, CO, LA
Derived failure modes
-
Potency or specification failure
Out of specification