Class II
Terminated
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.
This recall has been terminated (originally issued September 14, 2016).
- Company
- Allergy Laboratories, Inc.
- Recall Initiated
- August 10, 2016
- Posted
- September 14, 2016
- Recall Number
- D-1498-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,928,075 vials
- Firm Location
- Oklahoma City, OK, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Distribution
Nationwide
Lot / Code Info
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
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