Recalls / Class II

Class IID-66403-002

Product

Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-6895-01

Affected lot / code info

Lot #: 2003156, 2003157, 2003155, 3043491

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

4,722 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-66403-002. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.