Pfizer Recalls Elelyso Vials Due to Sterility Assurance Concerns
Pfizer is recalling 12,416 vials of Elelyso (taliglucerase alfa) because loose metal ferrule crimps may compromise 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 for an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Pfizer Inc. is recalling 12,416 vials of Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, NDC 0069-0106-01. The recall is limited to Lot S91616. The product is distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017.
The recall was initiated due to reports of loose metal ferrule crimps on the vials for injection. Specifically, the entire cap either lifted or dislodged while attempting to flip off the orange color plastic button. This defect raises a lack of assurance of sterility for the affected product.
The product was distributed nationwide in the U.S.A. Additionally, product from Lot S91616 was distributed to Albania, South Africa, Israel, Afghanistan, Rwanda, Botswana, Zimbabwe, and Iraq as part of the Compassionate Use Program. Patients and healthcare providers should stop using the affected vials and contact Pfizer or their healthcare provider for further instructions.
The recalled product
- Product
- ELELYSO (TALIGLUCERASE ALFA)
- Brand
- ELELYSO
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Injectable
- Affected units
- 12,416
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 (1)
- Lot S91616
Distribution
Distributed nationwide across the United States.
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