Allergy Laboratories Recalls Ephedrine Sulfate Injection Due to Sterility Concerns

Plain-English summary

Allergy Laboratories, Inc. is recalling Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vials. The product is packaged in 1 mL fill in a 2 mL Vial (NDC: 69053-008-01) and 25 x 2 mL Vials (NDC 69053-008-02). The recall affects 1,928,075 vials distributed nationwide.

The recall was initiated because an FDA inspection at the facility raised concerns that product sterility was potentially impacted. The agency has classified this as a Class II recall. Specific lot numbers and expiration dates are listed in the official recall notice.

Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions. Consumers should not use the product if they have questions about its sterility.

The recalled product

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.

Manufacturer

Allergy Laboratories, Inc.

Category

Drug — Injectable

Hazard

• sterility
• infection

Affected units

1,928,075

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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