FDA Drug recall D-1115-2018
Camber Pharmaceuticals, Inc
- FDA Drug
- Class II
- completed
- Published 2018-08-29
On 2018-08-29 the FDA classified a Class II recall of Camber Pharmaceuticals, Inc by Hetero Labs Unit V, citing CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1115-2018 |
| Classification | Class II |
| Status | completed |
| Initiated | 2018-08-08 |
| Published | 2018-08-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hetero Labs Unit V |
| Distribution | US |
Product
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905
Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Identifiers
| upc | 331722747905 |
|---|---|
| ndc | 31722-745-30 |
| ndc | 31722-745-90 |
| ndc | 31722-745-05 |
| ndc | 31722-745-31 |
| ndc | 31722-745-32 |
| ndc | 31722-746-30 |
| ndc | 31722-746-90 |
| ndc | 31722-746-05 |
| ndc | 31722-746-31 |
| ndc | 31722-746-32 |
| ndc | 31722-747-30 |
| ndc | 31722-747-90 |
| ndc | 31722-747-05 |
| ndc | 31722-747-31 |
| ndc | 31722-747-32 |
| ndc | 31722-748-30 |
| ndc | 31722-748-90 |
| ndc | 31722-748-05 |
| ndc | 31722-748-31 |
| ndc | 31722-748-32 |
| ndc | 3317227479 |
| code_info | All Lots with expiration dates 7/2018 to 6/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1115-2018%22
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