Hydrolytic Lysosomal Glucocerebroside-specific Enzyme
Where is Taliglucerase Alfa made?
1 company sell it under their own name. Their labels name 1 factory in the United States.
United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc Elelyso200 U per 5 mL · NDC 0069-0106 | Pharmacia & Upjohn Company LLCMakes it, packages it and labels it | Kalamazoo, MI, United States | Problems found, fixed voluntarilyJun 2023 |
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. - 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.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.