Drug recall D-0538-2021
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.
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots and codes
10116
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 131 bottles
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Lamotrigine Extended Release – drug information
- NDC 49884-561 Lamotrigine Extended Release · Lamotrigine 25 mg/1 · Par Health USA, LLC
- NDC 49884-604 Lamotrigine Extended Release · Lamotrigine 250 mg/1 · Par Health USA, LLC
- NDC 49884-605 Lamotrigine Extended Release · Lamotrigine 300 mg/1 · Par Health USA, LLC