Recalls / Class II
Class IID-0478-2017
Product
Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
- Affected lot / code info
- Lot # T04483, T04484, Exp 2/18; T06028, Exp 4/18; T08423, Exp 5/18
Why it was recalled
Failed tablet/capsule specification: missing break line on the 5mg tablet.
Recalling firm
- Firm
- Accord Healthcare, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1009 Slater Rd Ste 210B, N/A, Durham, North Carolina 27703-8446
Distribution
- Quantity
- 12896 bottles
- Distribution pattern
- U.S. Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-12-20
- FDA classified
- 2017-02-16
- Posted by FDA
- 2017-02-22
- Terminated
- 2017-08-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0478-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.