Drug 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
D-0982-2017
Product summary
- Firm
- Shionogi Inc.
- Event
- Event 77605
- Status
- Terminated
- Classification
- Class III
- Quantity
- 455 bottles
- Official record key
drug-enforcement:D-0982-2017
Official wording
Reason: Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Code information: Lot #: 5H66200103, Exp. June 2018
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications