FDA Drug recall D-0502-2017
Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., C…
- FDA Drug
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., C… by Sun Pharmaceutical Industries, citing presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0502-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-05 |
| Published | 2017-03-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, Gujarat, India, NDC 47335-956-88.
Reason
Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
Identifiers
| ndc | 47335-956-83 |
|---|---|
| ndc | 47335-956-81 |
| ndc | 47335-956-88 |
| ndc | 47335-956-08 |
| ndc | 47335-956-18 |
| code_info | Lot #: JKR5219A, JKR5200A, JKR5220A, JKR5221A, JKR5222A, Exp 03/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0502-2017%22
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