FDA Drug recall D-66403-005
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…
- FDA Drug
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of 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… by Mylan Pharmaceuticals, citing CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-66403-005 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-13 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
Product
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
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Identifiers
| code_info | Lot s: a) 3036490, 3036491, 3036492, 3039874; b) 3036493, 3036494, 3039872, 3039873, 3041476, 3041477, 3044555, 3044683 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-66403-005%22
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