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.
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
Lot numbers, UPCs & expiration codes
Lot S91616
Where it was sold
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.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0005-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 19, 2018
- FDA report date
- Oct 10, 2018
- Quantity
- 12,416 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0005-2019, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 81050
- Address
- 235 E 42nd St
- Code information
- Lot S91616
- Postal code
- 10017-5703
- Report date
- Oct 10, 2018
- Product type
- Drugs
- Recall number
- D-0005-2019
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 12,416 vials
- Termination date
- Jun 26, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- 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.
- Recall initiation date
- Sep 19, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 2, 2018