FDAFDA · Food and drugs·Recall number D-1116-2018
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
Published August 29, 2018 · Recall initiated: August 8, 2018
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VALSARTAN
- Manufacturer
- Hetero Labs Limited Unit V
- Distributor
- Nationwide
- UPC
- 331722748902
- Lot
- All Lots with expiration dates 7/2018 to 6/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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