FDAFDA · Food and drugs·Recall number D-0982-2017
PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981
Published July 26, 2017 · Recall initiated: May 24, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Shionogi Inc.
- Distributor
- Nationwide
- Lot
- Lot #: 5H66200103, Exp. June 2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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