FDA Drug Recalls

Recalls / Class III

Class IIID-269-2013

Product

Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10

Affected lot / code info
Lot# 3002450; exp 8/14

Why it was recalled

Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets..

Recalling firm

Firm
Mylan Pharmaceuticals Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
781 Chestnut Ridge Rd, Morgantown, West Virginia 26505-2730

Distribution

Quantity
2,405 bottles
Distribution pattern
Nationwide.

Timeline

Recall initiated
2013-02-26
FDA classified
2013-04-23
Posted by FDA
2013-05-01
Terminated
2013-12-05
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-269-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.