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
Reported: October 10, 2018 Initiated: September 19, 2018 #D-0005-2019
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.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 12,416 vials
- 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.
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Pfizer Inc.. Units affected: 12,416 vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 10, 2018. Severity: Moderate. Recall number: D-0005-2019.
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