FDA Drug recall D-1814-2015
Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd.…
- FDA Drug
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd.… by Apotex, citing failed Stability Specifications: product may not meet specification limit for assay test.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1814-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-17 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Apotex |
| Distribution | US |
Product
Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd., Bangalore, India, Manufactured for: Apotex Corp, Westin, FL, a) NDC 60505-3145-1, b) NDC 60505-3145-5
Reason
Failed Stability Specifications: product may not meet specification limit for assay test.
Identifiers
| code_info | Lot #s: a) KP9749, KT3501, Exp 09/2015, KP4524, Exp 11/2015, KV8264, Exp 01/2016, KX8713, KX8714, KX8715, Exp 04/2016;…Lot #s: a) KP9749, KT3501, Exp 09/2015, KP4524, Exp 11/2015, KV8264, Exp 01/2016, KX8713, KX8714, KX8715, Exp 04/2016; b) KP4525, Exp 11/2015, KP9750, Exp 12/2015, KX8716, Exp 04/2016 |
|---|
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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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1814-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.