FDA Drug recall D-1498-2016
Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01)
- FDA Drug
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01) by Allergy Laboratories, citing lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1498-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-10 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Allergy Laboratories |
| Distribution | US |
Product
Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605.
Reason
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Identifiers
| code_info | Lot #s: 102814, 102914, 103014, 103114, Exp 10/16; 110314, 110414, 110514, 110614, 110714, 111014, Exp 11/16; 121014, 1…Lot #s: 102814, 102914, 103014, 103114, Exp 10/16; 110314, 110414, 110514, 110614, 110714, 111014, Exp 11/16; 121014, 121114, 121214, 121514, Exp 12/16; 011415, 011515, 011615, 012015, 012115, Exp 01/17; 021315, 021715, 021815, 021915, 022015, Exp 02/17; 030415, 030515, 030615, 031015, 031715, Exp 03/17; 042415, 042815, 042915, 043015, Exp 04/17; 050115, 050515, 052815, 052915, Exp 05/17; 060315, 060415, 061615, 061715, Exp 06/17 |
|---|
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-1498-2016%22
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