AvKARE Recalls Lovastatin Tablets Due to Dissolution Failures
AvKARE Inc. is recalling 237 cartons of Lovastatin Tablets USP, 40 mg, because annual stability testing revealed low dissolution results.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving potential but unreported adverse health consequences.
Plain-English summary
AvKARE Inc. is recalling 237 cartons of Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton. The product is identified by NDC 50268-512-15, Lot 15270, and an expiration date of 01/18. The recall was initiated because annual stability testing showed low out-of-specification results for dissolution.
The affected product was distributed nationwide in the USA. Lovastatin is a prescription medication used to treat high cholesterol. The recall is classified as FDA Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for a replacement. Patients should not discontinue their medication without consulting their healthcare provider.
The recalled product
- Product
- Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
- Manufacturer
- AVKARE Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 237
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: 15270
- Exp. 01/18
Distribution
Distributed nationwide across the United States.
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