Key Takeaway

Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17 by Accord Healthcare, Inc. was recalled on December 20, 2016. The hazard: Failed tablet/capsule specification: missing break line on the 5mg tablet.

FDA Drug Class II Terminated

Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17

Recalled: December 20, 2016 ~12896 bottles units affected D-0478-2017

Description

Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17

Hazard / Reason

Failed tablet/capsule specification: missing break line on the 5mg tablet.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17

Drugs

Company Information

Accord Healthcare, Inc.

Durham, NC, United States

View all 93 recalls by Accord Healthcare, Inc. →

Distribution

U.S. Nationwide and Puerto Rico

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