Elelyso — Class II drug recall D-0005-2019
Terminated recall by Pfizer Inc., reported 2018-10-10, distributed nationwide. Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap e
| Recall number | D-0005-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2018-09-19 |
| Classified | 2018-10-02 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2020-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AF, IL, IQ, ZA |
| Quantity | 12,416 vials |
| Reason classes | sterility |
| NDC | 00069-0106, 00069-0106-01 |
| Lot numbers | 91616 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0005-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.