Recalls / Class III
Class IIID-0982-2017
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
- Affected lot / code info
- Lot #: 5H66200103, Exp. June 2018
Why it was recalled
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Recalling firm
- Firm
- Shionogi Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5770 Shiloh Rd, N/A, Alpharetta, Georgia 30005-8408
Distribution
- Quantity
- 455 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-05-24
- FDA classified
- 2017-07-14
- Posted by FDA
- 2017-07-26
- Terminated
- 2018-02-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0982-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.