Recalls / Class II

Class IID-66403-009

Product

Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labeled in part ***Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.***

Affected lot / code info

Lot #: a) 2003177, 2003178, 2003179, 2003180, 3043496; b) 2003176, 2003177, 3043496

Why it was recalled

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Recalling firm

Firm

Mylan Pharmaceuticals Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730

Distribution

Quantity

42,174 bottles

Distribution pattern

Nationwide and Puerto Rico

Timeline

Recall initiated

2013-09-13

FDA classified

2013-11-04

Posted by FDA

2013-11-13

Terminated

2015-07-23

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-66403-009. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.