NDC 0069-0106
Elelyso 200 U per 5 mL injection, powder, lyophilized, for solution
On the label: Pfizer Laboratories Div Pfizer Inc.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Pharmacia & Upjohn Company LLC | Kalamazoo, MI, United States | Makes it, packages it and labels it | Problems found, fixed voluntarilyJun 16, 2023 · 9 inspections |
| Pfizer Ireland Pharmaceuticals Unlimited Company | Dublin, Ireland | Tests it | Problems found, fixed voluntarilyDec 15, 2023 · 5 inspections |
Recalls
- Feb 27, 2020 · Class II · Pfizer Inc.
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.
Lots: Lot #: X14209, Exp. Date 02/2020; AH4601, Exp. Date 03/2020; AH4603, X46389, X78365, AT2927, Exp. Date 04/2020; AH4602, Exp. Date 05/2020; AL8590, Exp. Date 10/2020 - Sep 19, 2018 · Class II · Pfizer Inc.
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.
Lots: Lot S91616
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Taliglucerase Alfa: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 200 U per 5 mL
- Approval
- BLA BLA022458
- On the market since
- May 1, 2012
- Package NDCs
0069-0106-01- Official label
- DailyMed (National Library of Medicine), updated Dec 29, 2025
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