PONSTEL — Class III drug recall D-0982-2017
Terminated recall by Shionogi Inc., reported 2017-07-26, distributed nationwide. Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
| Recall number | D-0982-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shionogi Inc., Alpharetta, GA, United States |
| Recall initiated | 2017-05-24 |
| Classified | 2017-07-14 |
| Reported by FDA | 2017-07-26 |
| Terminated | 2018-02-28 |
| Distributed | Nationwide (US) |
| Quantity | 455 bottles |
| Reason classes | specification failure |
| Lot numbers | 5H66200103 |
| Expiration dates | 2018-06-20 |
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 for recall
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0982-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.