Recalls / Class II
Class IID-0005-2019
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
- Brand name
- Elelyso
- Generic name
- Taliglucerase Alfa
- Active ingredient
- Taliglucerase Alfa
- Route
- Intravenous
- NDC
- 0069-0106
- FDA application
- BLA022458
- Affected lot / code info
- Lot S91616
Why it was 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.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, New York, New York 10017-5703
Distribution
- Quantity
- 12,416 vials
- 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.
Timeline
- Recall initiated
- 2018-09-19
- FDA classified
- 2018-10-02
- Posted by FDA
- 2018-10-10
- Terminated
- 2020-06-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0005-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.