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
Reported: July 26, 2017 Initiated: May 24, 2017 #D-0982-2017
Product Description
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
Reason for Recall
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Details
- Recalling Firm
- Shionogi Inc.
- Units Affected
- 455 bottles
- Distribution
- Nationwide
- Location
- Alpharetta, GA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Shionogi Inc.. Units affected: 455 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 26, 2017. Severity: Low. Recall number: D-0982-2017.
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