Shionogi Recalls Mefenamic Acid Capsules for Dissolution Failures
Shionogi Inc. is recalling Mefenamic Acid 250mg 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 as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a failure to meet dissolution specifications without reported injuries.
Plain-English summary
Shionogi Inc. is recalling Mefenamic Acid, 250mg capsules, packaged in 30-count bottles. The product is distributed by Prasco Laboratories and manufactured by Halo Pharmaceutical Inc. The recall involves 6,304 bottles with Lot # 5H66200103G and an expiration date of June 2018.
The recall was initiated because low dissolution results were obtained during stability testing. This indicates that the medication may not dissolve at the required rate, which could affect its performance.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or physician for guidance on replacement or disposal.
The recalled product
- Product
- Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30
- Manufacturer
- Shionogi Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 6,304
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 #: 5H66200103G
- 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 →Related recalls
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