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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.*** Class II

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

Mylan Pharmaceuticals Inc. 20130913 Terminated
Distributed: Nationwide and Puerto Rico
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Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6899-01 Class II

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

Mylan Pharmaceuticals Inc. 20130913 Terminated
Distributed: Nationwide and Puerto Rico
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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. Class II

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

Mylan Pharmaceuticals Inc. 20130913 Terminated
Distributed: Nationwide and Puerto Rico
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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. Class II

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

Mylan Pharmaceuticals Inc. 20130913 Terminated
Distributed: Nationwide and Puerto Rico
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Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC 0378-5209-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Class II

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

Mylan Pharmaceuticals Inc. 20130913 Terminated
Distributed: Nationwide and Puerto Rico
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Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01 Class II

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

Mylan Pharmaceuticals Inc. 20130913 Terminated
Distributed: Nationwide and Puerto Rico
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Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Class II

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

Mylan Pharmaceuticals Inc. 20130913 Terminated
Distributed: Nationwide and Puerto Rico
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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 Class II

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

Mylan Pharmaceuticals Inc. 20130913 Terminated
Distributed: Nationwide and Puerto Rico
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Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Class II

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

Mylan Pharmaceuticals Inc. 20130913 Terminated
Distributed: Nationwide and Puerto Rico
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Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA 91320-1799,NDC 55513-710-01, UPC 3 55513 71001 5. Class II

Reason: Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.

Amgen, Inc. 20130917 Terminated
Distributed: Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.
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