Why it was recalled
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
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
Lot numbers, UPCs & expiration codes
Lot #: 5H66200103, Exp. June 2018
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0982-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 24, 2017
- FDA report date
- Jul 26, 2017
- Quantity
- 455 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shionogi Inc.
Original FDA data
Every field from FDA enforcement report D-0982-2017, exactly as published.
Show all FDA fields
- City
- Alpharetta
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 77605
- Address
- 5770 Shiloh Rd
- Code information
- Lot #: 5H66200103, Exp. June 2018
- Postal code
- 30005-8408
- Report date
- Jul 26, 2017
- Product type
- Drugs
- Recall number
- D-0982-2017
- Classification
- Class III
- Recalling firm
- Shionogi Inc.
- Product quantity
- 455 bottles
- Termination date
- Feb 28, 2018
- Reason for recall
- Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- May 24, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2017