Ephedrine Sulfate Injection — Class II drug recall D-1498-2016
Terminated recall by Allergy Laboratories, Inc., reported 2016-09-14, distributed nationwide. Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was p
| Recall number | D-1498-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Allergy Laboratories, Inc., Oklahoma City, OK, United States |
| Recall initiated | 2016-08-10 |
| Classified | 2016-09-07 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2017-03-13 |
| Distributed | Nationwide (US) |
| Quantity | 1,928,075 vials |
| Reason classes | sterility |
| NDC | 69053-0008-01, 69053-0008-02 |
| Lot numbers | 01/17, 011415, 011515, 011615, 012015, 012115, 02/17, 021315, 021715, 021815, 021915, 022015, 03/17, 030415, 030515, 030615, 031015, 031715, 04/17, 042415, 042815, 042915, 043015, 05/17, 050115, 050515, 052815, 052915, 06/17, 060315, 060415, 061615, 061715, 10/16, 102814, 102914, 103014, 103114, 11/16, 110314 and 10 more |
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 for recall
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1498-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.