Class II
Completed
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307
- Company
- Hetero Labs Limited Unit V
- Recall Initiated
- August 8, 2018
- Posted
- August 29, 2018
- Recall Number
- D-1113-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 316,380 bottles
- Firm Location
- Jadcherla Mandal, Mahaboob Nagar, India
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution
Nationwide
Lot / Code Info
All Lots with expiration dates 7/2018 to 6/2020
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