FDA Drug recall D-0413-2015
Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutiona…
- FDA Drug
- Class III
- terminated
- Published 2015-03-25
On 2015-03-25 the FDA classified a Class III recall of Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutiona… by Mylan Institutional, citing subpotent Drug and Failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0413-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-01-23 |
| Published | 2015-03-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Institutional |
| Distribution | US |
Product
Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10
Reason
Subpotent Drug and Failed Impurities/Degradation Specifications
Identifiers
| code_info | Lot #: UW301, UW302, Exp 02/15; UW303, UW304, UW305, UW306, Exp 04/15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class II · 2024-12-18 · Mylan Institutional - Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Man…
FDA Drug · Class II · 2024-12-18 · Mylan Institutional - Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Man…
FDA Drug · Class II · 2024-12-18 · Mylan Institutional
All Mylan Institutional recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0413-2015%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.