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.
Product description
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90
Lot numbers, UPCs & expiration codes
Lot #: E181370, Exp. 5/2020
Where it was sold
Indiana and Louisiana
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1211-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 12, 2018
- FDA report date
- Oct 3, 2018
- Quantity
- 5,424 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hetero Labs, Ltd. - Unit III
Original FDA data
Every field from FDA enforcement report D-1211-2018, exactly as published.
Show all FDA fields
- City
- Hyderabad
- Status
- Terminated
- Country
- India
- Event ID
- 81017
- Address
- Plot 22-110, Part Ii, Ida
- Address (line 2)
- Rangareddy, Jeedimetla
- Code information
- Lot #: E181370, Exp. 5/2020
- Report date
- Oct 3, 2018
- Product type
- Drugs
- Recall number
- D-1211-2018
- Classification
- Class III
- Recalling firm
- Hetero Labs, Ltd. - Unit III
- Product quantity
- 5,424 bottles
- Termination date
- Nov 29, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90
- Distribution pattern
- Indiana and Louisiana
- Recall initiation date
- Sep 12, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 25, 2018