Drug recall D-0219-2018

Class III Terminated reported Jan 24, 2018

Product

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

Lots and codes

Lot#: 7H66200103G, Exp 12/19

Recall details

Recalling firm
Shionogi Inc., Alpharetta, GA
Quantity
968 bottles
Distribution
U.S.A. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 24, 2017
Terminated
February 28, 2018