Reported Jul 26, 2017 · Terminated
PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park,…
Shionogi Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shionogi Inc. · 5770 Shiloh Rd · Alpharetta, GA · 30005-8408
Is this the product you have?
- PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only
- Manufactured forShionogi Inc. Florham Park
- NJ 07932 Manufactured byHalo Pharmaceutical Inc. Whippany, NJ 07981
- Lot codes and dates
Lot #: 5H66200103Exp. June 2018
- Amount recalled
- 455 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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