FDA Drug recall D-0412-2015
DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 1…
- FDA Drug
- Class III
- terminated
- Published 2015-03-25
On 2015-03-25 the FDA classified a Class III recall of DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 1… by Mylan Institutional, citing correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0412-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-02-11 |
| Published | 2015-03-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Institutional |
| Distribution | US |
Product
DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC, Glasgow, KY, 42141, NDC 53150-317-01.
Reason
Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL
Identifiers
| code_info | Lot Number: 7801009; Exp: Apr-2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Mylan Institutional
- Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton,…
FDA Drug · Class II · 2025-03-26 · Mylan Institutional - Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton,…
FDA Drug · Class II · 2025-03-26 · Mylan Institutional - Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manuf…
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-0412-2015%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.