Recalls / Class II

Class IID-66403-006

Product

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles (NDC 0378-6896-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

Affected lot / code info

Lot #: a) 2003159, 2003160, 2003161, 3043492; b) 2003158, 2003159, 3043492

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

30,878 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-66403-006. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.