American Health Packaging Recalls Lovastatin Tablets Due to CGMP Deviations
American Health Packaging is recalling 14,360 bottles of Lovastatin 40 mg tablets because the drug substance was out of specification for impurity results.
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 the violation is not likely to cause adverse health consequences. The hazard involves out-of-specification impurities without reported illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
American Health Packaging is recalling 14,360 bottles of Lovastatin Tablets USP, 40 mg. The affected products are packaged in 100-count bottles (NDC 68001-316-00) and 1,000-count bottles (NDC 68001-316-08). The specific lots involved are G702705 and G702706, both with an expiration date of March 31, 2020.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the finished product was manufactured using lovastatin drug substance that was out of specification for individual impurity results. The products were distributed nationwide within the United States and Puerto Rico.
Consumers who have these specific lots of Lovastatin tablets should stop using them and contact their healthcare provider or pharmacist for guidance. The products were manufactured by Lupin Limited for BluePoint Laboratories.
The recalled product
- Product
- LOVASTATIN (LOVASTATIN)
- Brand
- LOVASTATIN
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 14,360
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 #: a) G702705 and b) G702706
- Exp. 3/31/2020
UPCs (3)
- 0368001316002
- 0368001314008
- 0368001315005
Distribution
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