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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Edge Pharma, LLC: Epinephrine/Lidocaine Solution Recalled for Incorrect or Missing Labeling

Agency Publication Date: March 18, 2021
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Summary

Edge Pharma, LLC has recalled 60 syringes of Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection (0.025%/0.75%). The recall was initiated because the syringes were distributed with incorrect or missing lot numbers and expiration dates on the labels. These prescription syringes (0.8 mL) were distributed only in Pennsylvania and should be checked immediately for the specific lot number 10-2020-13.

Risk

Incorrect or missing expiration dates may lead to the use of a drug beyond its intended shelf life, while missing lot numbers prevent healthcare providers from identifying specific batches if safety issues arise.

What You Should Do

  1. Check your medical supplies for Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, 0.8 mL single-use syringes with NDC 05446-0863-01.
  2. Identify if your product belongs to lot number 10-2020-13@8 with an expiration date of 12/03/2020 or lot number 10-2020-13.
  3. If you have an affected syringe, stop using the product immediately and contact your healthcare provider or pharmacist for guidance.
  4. Return any unused syringes to the pharmacy or place of purchase for a refund and contact Edge Pharma, LLC at their Colchester, VT location for further instructions.
  5. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return for 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/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe
Model:
NDC 05446-0863-01
Recall #: D-0307-2021
Lot Numbers:
10-2020-13@8 (Exp 12/03/2020)
10-2020-13

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87514
Status: Resolved
Manufacturer: Edge Pharma, LLC
Sold By: Edge Pharma LLC
Manufactured In: United States
Units Affected: 60 syringes
Distributed To: Pennsylvania

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 ยท 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.