Recalls / Class III
Class IIID-1211-2018
Product
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90
- Brand name
- Fenofibrate
- Generic name
- Fenofibrate
- Active ingredient
- Fenofibrate
- Route
- Oral
- NDCs
- 31722-595, 31722-596
- FDA application
- ANDA204598
- Affected lot / code info
- Lot #: E181370, Exp. 5/2020
Why it was recalled
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.
Recalling firm
- Firm
- Hetero Labs, Ltd. - Unit III
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Plot 22-110, Part Ii, Ida, Rangareddy, Jeedimetla, Hyderabad, N/A, India
Distribution
- Quantity
- 5,424 bottles
- Distribution pattern
- Indiana and Louisiana
Timeline
- Recall initiated
- 2018-09-12
- FDA classified
- 2018-09-25
- Posted by FDA
- 2018-10-03
- Terminated
- 2018-11-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1211-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.