Recall record at a glance
| Official record | D-1114-2018 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Completed |
| Recalling firm | Hetero Labs Limited Unit V |
| Report date | Aug 29, 2018 |
| Recall initiation date | Aug 8, 2018 |
| Quantity | 394,896 bottles |
| Location | Jadcherla Mandal, Mahaboob Nagar, India |
Official product description
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, 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 31722-746-90 UPC 331722746908
Why the product was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution information
Nationwide
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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