FDA-Drug2017-07-26Class III

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

Shionogi Inc.
Hazard

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

Sold states
Nationwide
Affected count
6304 bottles
Manufactured in
5770 Shiloh Rd, N/A, Alpharetta, GA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0981-2017

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