Recalls / Class II

Class IID-66403-012

Product

Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

Affected lot / code info

Lot #: a) 3038984, 3038985, 3038986, 3041484, 3041485; b) 3036828, 3036829, 3036830, 3036831, 3036832, 3038987, 3038988, 3038989, 3038990, 3041480, 3041481, 3041482, 3041483, 3044522, 3044525

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

101,450 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-66403-012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.