Recalls / Class II
Class IID-1116-2018
Product
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
- Brand name
- Valsartan
- Generic name
- Valsartan
- Active ingredient
- Valsartan
- Route
- Oral
- NDCs
- 31722-745, 31722-746, 31722-747, 31722-748
- FDA application
- ANDA203311
- Affected lot / code info
- All Lots with expiration dates 7/2018 to 6/2020
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recalling firm
- Firm
- Hetero Labs Limited Unit V
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Unit V (SEZ Unit I in APIIC SEZ), Surv. No. 439-441, 458, Polepally Vill., Jadcherla Mandal, Mahaboob Nagar, N/A, India
Distribution
- Quantity
- 441,408 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-08-08
- FDA classified
- 2018-08-23
- Posted by FDA
- 2018-08-29
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1116-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.