Allergy Laboratories Recalls Ephedrine Sulfate Injection Due to Sterility Concerns
Allergy Laboratories is recalling Ephedrine Sulfate Injection vials because an FDA inspection raised concerns about product sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death if the product is contaminated.
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
- 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.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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