Drug 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
D-0219-2018
Product summary
- Firm
- Shionogi Inc.
- Event
- Event 78851
- Status
- Terminated
- Classification
- Class III
- Quantity
- 968 bottles
- Official record key
drug-enforcement:D-0219-2018
Official wording
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
Code information: Lot#: 7H66200103G, Exp 12/19
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign substance