Drug product
Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30
D-0981-2017
Product summary
- Firm
- Shionogi Inc.
- Event
- Event 77605
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6304 bottles
- Official record key
drug-enforcement:D-0981-2017
Official wording
Reason: Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Code information: Lot #: 5H66200103G, Exp. June 2018.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications