Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product description
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902
Lot numbers, UPCs & expiration codes
All Lots with expiration dates 7/2018 to 6/2020
Where it was sold
Nationwide
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-1116-2018
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Aug 8, 2018
- FDA report date
- Aug 29, 2018
- Quantity
- 441,408 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hetero Labs Limited Unit V
Original FDA data
Every field from FDA enforcement report D-1116-2018, exactly as published.
Show all FDA fields
- City
- Jadcherla Mandal, Mahaboob Nagar
- Status
- Completed
- Country
- India
- Event ID
- 80773
- Address
- Unit V (SEZ Unit I in APIIC SEZ)
- Address (line 2)
- Surv. No. 439-441, 458, Polepally Vill.
- Code information
- All Lots with expiration dates 7/2018 to 6/2020
- Report date
- Aug 29, 2018
- Product type
- Drugs
- Recall number
- D-1116-2018
- Classification
- Class II
- Recalling firm
- Hetero Labs Limited Unit V
- Product quantity
- 441,408 bottles
- Reason for recall
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 8, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 23, 2018