Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Epinephrine Auto-Injectors Recalled Due to Potential Activation Failure

Agency Publication Date: May 4, 2020

Summary

Teva Pharmaceuticals USA is recalling 600 cartons (1,200 units) of Epinephrine Injection USP, 0.3 mg (Auto-Injectors). The recall was initiated because a specific component shared with other lots was found to be out-of-specification for 'trigger force,' which could prevent the device from activating correctly during an emergency. This recall affects generic epinephrine auto-injectors typically used for the emergency treatment of severe allergic reactions (anaphylaxis). Consumers who have this medication should check their lot numbers immediately and contact their healthcare provider or pharmacist for guidance.

Risk

The device may require excessive force to activate or may fail to fire altogether, which could delay or prevent the delivery of life-saving medication during a life-threatening allergic reaction.

What You Should Do

Check your medication packaging for Epinephrine Injection USP, 0.3 mg (Auto-Injector) with NDC 0093-5986-27.
Verify if your product belongs to Lot # 007F19AA with an expiration date of 04/2021.
If you have the affected lot, contact your healthcare provider or pharmacist immediately to discuss obtaining a replacement or alternative treatment.
Do not attempt to use or test the device if it is from the affected lot unless in an absolute emergency where no other treatment is available.
Return any unused, affected product to the pharmacy where it was purchased for a refund and further instructions.
Contact Teva Pharmaceuticals USA directly for additional information regarding this recall at their corporate office in Parsippany, NJ.
For further questions or to report a problem, 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: Epinephrine Injection USP, 0.3 mg (Auto-Injector), 2 auto-injectors per carton

Model:

NDC 0093-5986-27

Recall #: D-1260-2020

Lot Numbers:

007F19AA (Exp. 04/2021)

Date Ranges: Expiration date 04/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85146

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Sold By: wholesaler

Manufactured In: United States

Units Affected: 600 cartons/2 auto-injector per carton

Distributed To: Nationwide

Agency Last Updated: May 5, 2020

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

Check your medication packaging for Epinephrine Injection USP, 0.3 mg (Auto-Injector) with NDC 0093-5986-27.

Verify if your product belongs to Lot # 007F19AA with an expiration date of 04/2021.

If you have the affected lot, contact your healthcare provider or pharmacist immediately to discuss obtaining a replacement or alternative treatment.

Do not attempt to use or test the device if it is from the affected lot unless in an absolute emergency where no other treatment is available.

Return any unused, affected product to the pharmacy where it was purchased for a refund and further instructions.

Contact Teva Pharmaceuticals USA directly for additional information regarding this recall at their corporate office in Parsippany, NJ.

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