FDA Drug recall D-0982-2017
PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc
- FDA Drug
- Class III
- terminated
- Published 2017-07-26
On 2017-07-26 the FDA classified a Class III recall of PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc by Shionogi, citing failed Dissolution Specifications: Low dissolution results were obtained during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0982-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-05-24 |
| Published | 2017-07-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Shionogi |
| Distribution | US |
Product
PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981
Reason
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Identifiers
| code_info | Lot #: 5H66200103, Exp. June 2018 |
|---|
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-0982-2017%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.