Alpharetta, GA, United States
Shionogi Inc. recalls
1 recall recorded since 2018, most recently on 24 May 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 24 May 2017
- Terminated
- 28 February 2018
- Reason
- 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
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0219-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.