D-0005-2019 Class II Terminated
FDA drug recall D-0005-2019 was initiated by Pfizer Inc. on Sep 19, 2018 and is designated Class II. 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. The recall status is terminated (terminated Jun 26, 2020). Affected quantity: 12,416 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 10, 2018
- Initiation Date
- Sep 19, 2018
- Termination Date
- Jun 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,416 vials
Product Description
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
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.
Distribution Pattern
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.
Code Information
Lot S91616
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0005-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026