American Health Packaging Recalls Subpotent Methylprednisolone Tablets
American Health Packaging is recalling 2,005 cartons of Methylprednisolone 4 mg tablets because they failed to meet potency standards at a 6-month stability time point.
What this means for you
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, fitting the 'Low' severity criteria for documentation or minor quality issues.
Plain-English summary
American Health Packaging is recalling 2,005 cartons of MethylPREDNISolone Tablets, USP, 4 mg. The affected products are packaged in 100 unit dose blisters and distributed nationwide. The recall involves specific lots with expiration dates of 05/2015.
The recall was initiated because the tablets were found to be subpotent at a 6-month stability time point. This means the medication may not contain the full amount of the active ingredient required to be effective. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase for a refund or replacement. The affected NDC numbers are 68084-149-01 for cartons and 68084-149-11 for individual doses.
The recalled product
- Product
- METHYLPREDNISOLONE (METHYLPREDNISOLONE)
- Brand
- METHYLPREDNISOLONE
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,005
Distribution
Distributed nationwide across the United States.
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