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.
Reported: September 14, 2016 Initiated: August 10, 2016 #D-1498-2016
Product Description
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.
Details
- Recalling Firm
- Allergy Laboratories, Inc.
- Units Affected
- 1,928,075 vials
- Distribution
- Nationwide
- Location
- Oklahoma City, OK
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Allergy Laboratories, Inc.. Units affected: 1,928,075 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 14, 2016. Severity: Moderate. Recall number: D-1498-2016.
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