Recalls / Class III
Class IIID-0219-2018
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
- Affected lot / code info
- Lot#: 7H66200103G, Exp 12/19
Why it was 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
Recalling firm
- Firm
- Shionogi Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5770 Shiloh Rd, N/A, Alpharetta, Georgia 30005-8408
Distribution
- Quantity
- 968 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2017-05-24
- FDA classified
- 2018-01-12
- Posted by FDA
- 2018-01-24
- Terminated
- 2018-02-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0219-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.