The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0982-2017·Announced 2017-07-26

Shionogi Recalls PONSTEL Capsules Due to Failed Dissolution Specifications

Shionogi Inc. is recalling 455 bottles of PONSTEL capsules because stability testing showed low dissolution results.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which is defined as unlikely to cause adverse health consequences. The issue is a failure in dissolution specifications during stability testing, which is a quality control issue rather than a direct safety hazard like contamination or mislabeling.

Plain-English summary

Shionogi Inc. is recalling 455 bottles of PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles. The product is prescription-only and was manufactured by Halo Pharmaceutical Inc. for Shionogi Inc.

The recall was initiated because low dissolution results were obtained during stability testing. The affected product is identified by Lot # 5H66200103 with an expiration date of June 2018. The recall is classified as Class III by the FDA.

The product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

Product
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
Manufacturer
Shionogi Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
455

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 5H66200103
  • Exp. June 2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Shionogi Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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