Recalls / Class III
Class IIID-0981-2017
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
- Affected lot / code info
- Lot #: 5H66200103G, 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
- 6304 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-0981-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.