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.
Reported: November 13, 2013 Initiated: September 13, 2013 #D-66403-005
Product Description
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.
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
- 167,866 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 167,866 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-66403-005.
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