Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., D...
FDA Recall #D-0478-2017 — Class II — December 20, 2016
Product Description
Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
Reason for Recall
Failed tablet/capsule specification: missing break line on the 5mg tablet.
Recalling Firm
Accord Healthcare, Inc. — Durham, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
12896 bottles
Distribution
U.S. Nationwide and Puerto Rico
Code Information
Lot # T04483, T04484, Exp 2/18; T06028, Exp 4/18; T08423, Exp 5/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated