Recalls / Class III
Class IIID-0074-2018
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
- Affected lot / code info
- Lot #:167194; Exp. 12/31/2018
Why it was recalled
Failed Stability Specifications
Recalling firm
- Firm
- Amerisource Health Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 93,600 tablets
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2017-08-29
- FDA classified
- 2017-11-10
- Posted by FDA
- 2017-11-22
- Terminated
- 2019-08-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0074-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.