Reported Sep 14, 2016 · Terminated
Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC:…
Allergy Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Allergy Laboratories, Inc. · 1005 SW 2nd St · Oklahoma City, OK · 73109-1006
Is this the product you have?
- 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 forAndersen Pharmaceutical, White Plains, NY 10605
- Lot codes and dates
Lot #s: 102814102914103014103114Exp 10/16110314110414110514110614110714111014Exp 11/16121014121114121214121514Exp 12/16011415011515011615012015012115Exp 01/17021315021715021815021915022015Exp 02/17030415030515030615031015031715Exp 03/17042415042815042915043015Exp 04/17050115050515052815052915Exp 05/17060315060415061615061715Exp 06/17
- Amount recalled
- 1,928,075 vials
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
This product could cause temporary or reversible health problems — stop using it.
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