Amerisource Recalls Enalapril Maleate Tablets Due to Stability Failures
Amerisource Health Services is recalling Enalapril Maleate Tablets, 5 mg, because the product failed stability specifications.
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 agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences. The source text does not report any illnesses or injuries.
Plain-English summary
Amerisource Health Services is recalling Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. The product is packaged and distributed by American Health Packaging in Columbus, Ohio, and carries the NDC 68084-390-01.
The recall was initiated because the product failed stability specifications. The affected lot number is 167194, with an expiration date of 12/31/2018. The total quantity involved is 93,600 tablets.
The product was distributed nationwide in the United States and Puerto Rico. Consumers and healthcare providers should stop using the affected tablets and contact their pharmacist or healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 93,600
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 #:167194
- Exp. 12/31/2018
Distribution
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