Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01
Reported: March 11, 2020 Initiated: February 27, 2020 #D-0995-2020
Product Description
Elelyso (taliglucerase alfa) for injection, 200 units/vials,, 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
- 24,714 vials
- Distribution
- Nationwide within the United States and Albania, Israel, Serbia, Macedonia, Afghanistan, Botswana/South Africa/Zimbabwe, India, Israel, Rwanda, Uruguay, Mongolia
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01. Recalled by Pfizer Inc.. Units affected: 24,714 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 March 11, 2020. Severity: Moderate. Recall number: D-0995-2020.
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