D-0219-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 24, 2018
- Initiation Date
- May 24, 2017
- Termination Date
- February 28, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 968 bottles
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
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot#: 7H66200103G, Exp 12/19