FDA Drug recall D-0219-2018
Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo P…
- FDA Drug
- Class III
- terminated
- Published 2018-01-24
On 2018-01-24 the FDA classified a Class III recall of Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo P… by Shionogi, citing presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0219-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-05-24 |
| Published | 2018-01-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Shionogi |
| Distribution | US |
Product
Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30
Reason
Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
Identifiers
| code_info | Lot#: 7H66200103G, Exp 12/19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0219-2018%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.