FDA Drug recall D-1435-2014
Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by:…
- FDA Drug
- Class III
- terminated
- Published 2014-07-23
On 2014-07-23 the FDA classified a Class III recall of Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by:… by Mylan Institutional D B A Udl Laboratories, citing failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1435-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-07-03 |
| Published | 2014-07-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Institutional D B A Udl Laboratories |
| Distribution | US |
Product
Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
Reason
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Identifiers
| code_info | Lot #: 3045659, 3048256, Exp 07/14 |
|---|
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-1435-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.