Medications & Supplements/Prescription Drugs

Epi-Caine Injection Recalled Due to Discolored Raw Materials

Agency Publication Date: January 5, 2023

Summary

Pine Pharmaceuticals, LLC is recalling 11,453 vials of Epi-Caine (epinephrine 0.025% and lidocaine HCL 0.75%) intraocular injection solution. This recall was initiated because the raw materials used to manufacture the drug were discolored, indicating potential quality and manufacturing issues. The affected 1 ml single-dose vials were distributed nationwide to medical facilities for use in surgical procedures.

Risk

Using a medication manufactured with discolored or degraded raw materials may lead to sub-potent treatment or unpredictable adverse reactions during eye surgery. No injuries or adverse events have been reported to date regarding this issue.

What You Should Do

This recall affects Epi-Caine (epinephrine 0.025% and lidocaine HCL 0.75%) Solution for Intraocular Injection, packaged in 1 ml single-dose vials (NDC 69194-0948-1).
Check your facility inventory for lot numbers including 62881, 62923, 63066, 63067, 63103, and others with expiration dates ranging from December 2022 to February 2023. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product immediately and quarantine any remaining stock to prevent further use in medical procedures.
Contact Pine Pharmaceuticals, LLC or your medical distributor directly to arrange for the return of any unused vials.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information or to report a concern.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection (1 ml)

Variants: Single Dose Vial, 1 ml

Lot Numbers:

62881 (Exp 12/25/2022)

62923 (Exp 12/26/2022)

63066 (Exp 01/03/2023)

63067 (Exp 01/01/2023)

63103 (Exp 01/02/2023)

63120 (Exp 01/03/2023)

63219 (Exp 01/08/2023)

63226 (Exp 01/08/2023)

63263 (Exp 01/09/2023)

63380 (Exp 01/15/2023)

63381 (Exp 01/15/2023)

63433 (Exp 01/16/2023)

63455 (Exp 01/17/2023)

63537 (Exp 01/22/2023)

63580 (Exp 01/23/2023)

63721 (Exp 01/29/2023)

63792 (Exp 01/31/2023)

63888 (Exp 02/05/2023)

63930 (Exp 02/06/2023)

63959 (Exp 02/07/2023)

64079 (Exp 02/13/2023)

64109 (Exp 02/14/2023)

64239 (Exp 02/21/2023)

NDC:

69194-0948-1

Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. Total quantity: 11,453 vials.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91378

Status: Resolved

Manufacturer: Pine Pharmaceuticals, LLC

Sold By: medical facilities

Manufactured In: United States

Units Affected: 11,453 vials

Distributed To: Nationwide

Agency Last Updated: January 13, 2023

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

This recall affects Epi-Caine (epinephrine 0.025% and lidocaine HCL 0.75%) Solution for Intraocular Injection, packaged in 1 ml single-dose vials (NDC 69194-0948-1).

Check your facility inventory for lot numbers including 62881, 62923, 63066, 63067, 63103, and others with expiration dates ranging from December 2022 to February 2023. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product immediately and quarantine any remaining stock to prevent further use in medical procedures.

Contact Pine Pharmaceuticals, LLC or your medical distributor directly to arrange for the return of any unused vials.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information or to report a concern.

Affected Products

Product: Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection (1 ml)

Variants: Single Dose Vial, 1 ml

Lot Numbers:

62881 (Exp 12/25/2022)

62923 (Exp 12/26/2022)

63066 (Exp 01/03/2023)

63067 (Exp 01/01/2023)

63103 (Exp 01/02/2023)

63120 (Exp 01/03/2023)

63219 (Exp 01/08/2023)

63226 (Exp 01/08/2023)

63263 (Exp 01/09/2023)

63380 (Exp 01/15/2023)

63381 (Exp 01/15/2023)

63433 (Exp 01/16/2023)

63455 (Exp 01/17/2023)

63537 (Exp 01/22/2023)

63580 (Exp 01/23/2023)

63721 (Exp 01/29/2023)

63792 (Exp 01/31/2023)

63888 (Exp 02/05/2023)

63930 (Exp 02/06/2023)

63959 (Exp 02/07/2023)

64079 (Exp 02/13/2023)

64109 (Exp 02/14/2023)

64239 (Exp 02/21/2023)

NDC:

69194-0948-1

Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. Total quantity: 11,453 vials.