Reported Aug 29, 2018 · Completed
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber…
Hetero Labs Limited Unit V
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hetero Labs Limited Unit V · Unit V (SEZ Unit I in APIIC SEZ) · Jadcherla Mandal, Mahaboob Nagar · N/A
Is this the product you have?
- Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles
- Rx Only Manufactured forCamber Pharmaceuticals, Inc
- Piscataway NJ 08854 ByHetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-746-90 UPC 331722746908
- Lot codes and dates
- All Lots with expiration dates 7/2018 to 6/2020
- Amount recalled
- 394,896 bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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