Class III · Low risk
Mefenamic Acid
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
PONSTEL (Mefanamic Acid)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What 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
- Recalling firm
- Shionogi Inc.
- Origin
- GA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0982-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Shionogi Inc.
All 2017 recalls
Class III · Low risk
Mefenamic Acid Capsules
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
Class III · Low risk
Nisoldipine Extended Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Nisoldipine Extended Release Tablets
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Other dissolution failure recalls from 2017
All dissolution failure recalls
Class III · Low risk
Duloxetine Delayed-Release Capsules USP
Failed Dissolution Specification
Class II · Moderate risk
Liothyronine Sodium Tablets
Failed Dissolution Specifications.
Class II · Moderate risk
Dutasteride and Tamsulosin HCl Capsules
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Class III · Low risk
Methylphenidate Hydrochloride Tablets USP
Failed Dissolution Specifications: Low out of specification results for dissolution.
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