Qualitest Recalls Subpotent Methylprednisolone Tablets Due to Stability Issues
Qualitest Pharmaceuticals is recalling specific lots of Methylprednisolone 4 mg tablets because they may be subpotent due to a 6-month stability time point issue.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a remote possibility of adverse health consequences. The issue is subpotency due to a stability time point, which is a quality defect rather than a high-risk contamination or structural defect, fitting the Moderate severity criteria for minor labeling or quality errors.
Plain-English summary
Qualitest Pharmaceuticals is voluntarily recalling specific lots of Methylprednisolone 4 mg tablets. The recall was initiated because the product is subpotent, meaning it may not contain the full labeled amount of the active ingredient, due to a 6-month stability time point issue.
The affected products are Methylprednisolone tablets, USP 4 mg, available in 100-count bottles (NDC 0603-4593-21) and 21-count blister packs (NDC 0603-4593-15). The specific lot codes are T147F13A for the 100-count bottles and S003M14 for the 21-count blister packs. Both lots have an expiration date of 05/2015. A total of 159,913 tablets are involved in this recall, which has a nationwide distribution pattern.
Consumers and healthcare providers should check their inventory for these specific NDCs and lot codes. If found, the product should be returned to the pharmacy or supplier for credit. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed these specific lots.
The recalled product
- Product
- METHYLPREDNISOLONE (METHYLPREDNISOLONE)
- Brand
- METHYLPREDNISOLONE
- Manufacturer
- Qualitest Pharmaceuticals
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 159,913
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 (3)
- 100 count: T147F13A
- Exp. 05/2015
- 21 count: S003M14
UPCs (1)
- 0306034593212
Distribution
Distributed nationwide across the United States.
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