Medications & Supplements/Prescription Drugs

Pfizer Inc.: Elelyso Injection Recalled Due to Potential Lack of Sterility

Agency Publication Date: March 5, 2020

Summary

Pfizer Inc. is recalling 24,714 vials of Elelyso (taliglucerase alfa) for injection (200 units/vial), a prescription medication. The recall was initiated because the metal caps on the vials may be loose; in some cases, the entire cap can lift or dislodge when a user tries to flip off the orange plastic button. This defect compromises the sterile seal of the vial, which is critical for injectable medications. Consumers should check their supply for specific lot numbers with expiration dates ranging from February to October 2020. If you have an affected vial, contact your healthcare provider or pharmacist immediately for guidance and to arrange for a replacement.

Risk

The loose metal caps prevent a proper sterile seal on the medication vials. Using a medication that is not guaranteed to be sterile can lead to serious infections or other systemic health complications when the drug is injected.

What You Should Do

Identify if you have the affected Elelyso (taliglucerase alfa) 200 units/vial by checking for NDC 0069-0106-01 on the packaging.
Check your vials for the following lot numbers and expiration dates: Lot X14209 (Exp. 02/2020), Lot AH4601 (Exp. 03/2020), Lots AH4603, X46389, X78365, or AT2927 (Exp. 04/2020), Lot AH4602 (Exp. 05/2020), and Lot AL8590 (Exp. 10/2020).
Inspect the vial cap carefully; if the metal ring appears loose or if the entire cap dislodges when removing the orange plastic button, do not use the medication.
Contact your healthcare provider or pharmacist immediately to discuss alternative supplies and ensure your treatment is not interrupted.
Return any unused vials from the affected lots to your pharmacy for a refund and contact Pfizer for further instructions on the return process.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Elelyso (taliglucerase alfa) for injection (200 units/vial)

Model:

NDC 0069-0106-01

Lot Numbers:

X14209 (Exp. 02/2020)

AH4601 (Exp. 03/2020)

AH4603 (Exp. 04/2020)

X46389 (Exp. 04/2020)

X78365 (Exp. 04/2020)

AT2927 (Exp. 04/2020)

AH4602 (Exp. 05/2020)

AL8590 (Exp. 10/2020)

Date Ranges: February 2020, March 2020, April 2020, May 2020, October 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85067

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Pfizer Labs; Hospitals; Pharmacies

Manufactured In: United States

Units Affected: 24,714 vials

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected Elelyso (taliglucerase alfa) 200 units/vial by checking for NDC 0069-0106-01 on the packaging.

Check your vials for the following lot numbers and expiration dates: Lot X14209 (Exp. 02/2020), Lot AH4601 (Exp. 03/2020), Lots AH4603, X46389, X78365, or AT2927 (Exp. 04/2020), Lot AH4602 (Exp. 05/2020), and Lot AL8590 (Exp. 10/2020).

Inspect the vial cap carefully; if the metal ring appears loose or if the entire cap dislodges when removing the orange plastic button, do not use the medication.

Contact your healthcare provider or pharmacist immediately to discuss alternative supplies and ensure your treatment is not interrupted.

Return any unused vials from the affected lots to your pharmacy for a refund and contact Pfizer for further instructions on the return process.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Elelyso (taliglucerase alfa) for injection (200 units/vial)

Model:

NDC 0069-0106-01

Lot Numbers:

X14209 (Exp. 02/2020)

AH4601 (Exp. 03/2020)

AH4603 (Exp. 04/2020)

X46389 (Exp. 04/2020)

X78365 (Exp. 04/2020)

AT2927 (Exp. 04/2020)

AH4602 (Exp. 05/2020)

AL8590 (Exp. 10/2020)

Date Ranges: February 2020, March 2020, April 2020, May 2020, October 2020