Methylprednisolone Tablets Recalled for Potential Impurity Specification Failure
Physicians Total Care Inc. is recalling Methylprednisolone Tablets, USP, 4 mg, due to potential failure to meet Impurity C specifications.
What this means for you
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 II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any illnesses or injuries, and the hazard is a potential specification failure rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
Physicians Total Care Inc. is recalling Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle (NDC # 54868-2913-03). The recall involves 60 bottles distributed in Georgia and Pennsylvania.
The product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life. The affected lots include # 5ASX (Exp 10/31/2011), 5O37, 5QSQ, 5T6J, 5U7Z, 5WIC, 5XDS, 5ZHY, 601J, 63MJ, and 64O0 (Exp. 02/28/2012).
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Distributed by: Physicians Total Care Inc., Tulsa, OK 74146, NDC # 54868-2913-03
- Manufacturer
- Physicians Total Care, Inc.
- Category
- Drug — Tablets
- Affected units
- 60
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 (13)
- Lot # 5ASX
- Exp 10/31/2011
- 5O37
- 5QSQ
- 5T6J
- 5U7Z
- 5WIC
- 5XDS
- 5ZHY
- 601J
- 63MJ
- 64O0
- Exp. 02/28/2012.
Distribution
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