Pfizer Recalls Elelyso Vials Due to Sterility Assurance Concerns
Pfizer is recalling 24,714 vials of Elelyso (taliglucerase alfa) for injection due to reports of loose metal ferrule crimps that 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 infection or serious injury.
Plain-English summary
Pfizer Inc. is recalling 24,714 vials of Elelyso (taliglucerase alfa) for injection, 200 units/vials. The recall is due to reports of loose metal ferrule crimps on the vials, where 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 product.
The affected product is distributed nationwide within the United States and in several international locations, including Albania, Israel, Serbia, Macedonia, Afghanistan, Botswana/South Africa/Zimbabwe, India, Rwanda, Uruguay, and Mongolia. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring between February and October 2020.
Healthcare providers and patients should stop using the affected vials and contact Pfizer or their healthcare provider for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- ELELYSO (TALIGLUCERASE ALFA)
- Brand
- ELELYSO
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Injectable
- Affected units
- 24,714
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 (13)
- Lot #: X14209
- Exp. Date 02/2020
- AH4601
- Exp. Date 03/2020
- AH4603
- X46389
- X78365
- AT2927
- Exp. Date 04/2020
- AH4602
- Exp. Date 05/2020
- AL8590
- Exp. Date 10/2020
Distribution
Distributed nationwide across the United States.
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