PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: July 26, 2017 Initiated: May 24, 2017 #D-0981-2017

Product Description

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

Reason for Recall

Failed Dissolution Specifications: Low dissolution results were obtained during stability testing

Details

Recalling Firm
Shionogi Inc.
Units Affected
6304 bottles
Distribution
Nationwide
Location
Alpharetta, GA

Frequently Asked Questions

What product was recalled?
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. Recalled by Shionogi Inc.. Units affected: 6304 bottles.
Why was this product recalled?
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Which agency issued this recall?
This recall was issued by the FDA Drug on July 26, 2017. Severity: Low. Recall number: D-0981-2017.