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.***
Reported: November 13, 2013 Initiated: September 13, 2013 #D-66403-009
Product Description
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.***
Reason for Recall
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 42,174 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
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.***. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 42,174 bottles.
Why was this product recalled? ▼
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 13, 2013. Severity: Moderate. Recall number: D-66403-009.
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