Reported Jul 18, 2018 · Terminated
Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and…
American Health Packaging
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AMERICAN HEALTH PACKAGING · 2550 John Glenn Ave Ste A · Columbus, OH · 43217-1188
Is this the product you have?
Enalapril Maleate Tablets USP5 mg100 Tablets (10X10) blister cards12 cartons in a shipperRx
- Packaged and Distributed byAmerican Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]
- Lot codes and dates
- Lot# 166023 - Exp. 11/30/18 (232 units). Lot# 168467 - Exp. 2/28/19 (1053 units).
- Amount recalled
- 1285 cartons (cartons of 100 individual unit doses)
Why it was recalled
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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