PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: January 24, 2018 Initiated: May 24, 2017 #D-0219-2018

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Shionogi Inc.
Units Affected
968 bottles
Distribution
U.S.A. Nationwide
Location
Alpharetta, GA

Frequently Asked Questions

What product was recalled?
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. Recalled by Shionogi Inc.. Units affected: 968 bottles.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Drug on January 24, 2018. Severity: Low. Recall number: D-0219-2018.