FDA Drug recall D-059-2013
Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets
- FDA Drug
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets by Dr Reddy S Laboratories, citing failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-059-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-27 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
Reason
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Identifiers
| code_info | Lot C203090 Exp.03/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class III · 2024-12-18 · Dr Reddy S Laboratories
All Dr Reddy S Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-059-2013%22
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