Drug product
Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-11 Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Zhejiang 317024 China For Par Pharmaceutical Companes, Inc. Spring Valley, NY 10977 U.S.A.
D-0538-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 131 bottles
- Official record key
drug-enforcement:D-0538-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 10116
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations