Recalls / Class II

Class IID-66403-007

Product

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count bottles (NDC 0378-6897-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

Affected lot / code info

Lot #: a) 2003169, 2003170, 2003171, 2003172, 2003173, 3043493; b) 2003168, 2003169, 3043493

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

60,506 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-66403-007. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.