FDA-Drug2018-01-24Class III

Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30

Shionogi Inc.
Hazard

Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules

Sold states
U.S.A. Nationwide
Affected count
968 bottles
Manufactured in
5770 Shiloh Rd, N/A, Alpharetta, GA, United States
Products
Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, 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-0219-2018

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