September 2018 FDA Recall Elelyso by Pfizer Inc.
D-0005-2019 - Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.

This Class II drug recall was voluntarily initiated by Pfizer Inc. on September 19, 2018 for the product Elelyso. The FDA reported the reason for recall as lack of assurance of sterility -reports of loose metal ferrule crimps on vials for injection. the entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0005-2019

Reason for Recall
Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Initiated
09-19-2018
Reported
10-10-2018
Quantity
12,416 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81050
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. nationwide. The following countries received product from Lot S91616: Albania, South Africa, Israel, Afghanistan, Rwanda, Botswana, Zimbabwe and Iraq as part of the Compassionate Use Program.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-26-2020
Product Description About Product Description
Full technical description of the product.
Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-0106-01

Batch or Lot Expiration Information

Lot# Lot S91616

Affected Packages Involved in this Recall

0069-0106-01 Elelyso