Biocon Recalls Subpotent Simvastatin Tablets Due to Quality Concerns
Biocon Inc is voluntarily recalling 5,505 bottles of Simvastatin Tablets USP 5 mg because the drug was found to be subpotent. The affected lots were distributed in Pennsylvania, California, and Ohio.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor quality issues without reported harm.
Plain-English summary
Biocon Inc is voluntarily recalling 5,505 bottles of Simvastatin Tablets, USP 5 mg, prescription only. The recall involves two package sizes: 90-count bottles (NDC 24658-0300-90) and 1,000-count bottles (NDC 24658-0300-10). The specific lot number is 14S0042F5B, with an expiration date of 4/2016. The product was manufactured by Blu Caribe in Dorado, Puerto Rico, for Blu Pharmaceuticals in Franklin, Kentucky.
The recall was initiated because the drug was identified as subpotent, meaning it did not contain the full amount of the active ingredient required by the United States Pharmacopeia (USP). This is a Class III recall, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed in Pennsylvania, California, and Ohio. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the supplier or disposed of according to local regulations. No specific consumer action is mandated beyond identifying and removing the affected stock.
The recalled product
- Product
- Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134
- Manufacturer
- Biocon Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 5,505
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 # 14S0042F5B
- exp. 4/2016
Distribution
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