D-1211-2018 Class III Terminated
FDA drug recall D-1211-2018 was initiated by Hetero Labs, Ltd. - Unit III on September 12, 2018 and is designated Class III. Reason for recall: Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg. The recall status is terminated (terminated November 29, 2018). Affected quantity: 5,424 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 3, 2018
- Initiation Date
- September 12, 2018
- Termination Date
- November 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,424 bottles
Product Description
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90
Reason for Recall
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Distribution Pattern
Indiana and Louisiana
Code Information
Lot #: E181370, Exp. 5/2020