American Health Packaging Recalls Enalapril Maleate Tablets Due to Impurities
American Health Packaging is recalling specific lots of Enalapril Maleate Tablets USP, 5 mg, due to out-of-specification results for a degradation product.
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 FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
American Health Packaging is recalling Enalapril Maleate Tablets USP, 5 mg, in 100-tablet blister cards. The recall involves Lot #166023 (expiration 11/30/18) and Lot #168467 (expiration 2/28/19). The total quantity recalled is 1,285 cartons, which contain 100 individual unit doses each.
The recall was initiated because the product failed impurities and degradation specifications, specifically showing out-of-specification results for the Enalapril DKT degradant. The FDA has classified this as a Class III recall, indicating that while there is a violation of FDA regulations, it is unlikely to cause adverse health consequences.
The affected products were distributed to wholesalers between December 29, 2016, and September 11, 2017. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the product should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]
- Manufacturer
- AMERICAN HEALTH PACKAGING
- Category
- Drug — Prescription Medication
- Hazard
Distribution
Distribution scope not specified by the agency.
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