Medications & Supplements/Prescription Drugs

Pine Pharmaceuticals Bupivacaine and Lidocaine Injection Recalled for Lack of Sterility

Agency Publication Date: September 15, 2022

Summary

Pine Pharmaceuticals, LLC has recalled Bupivacaine HCl 0.375% and Lidocaine HCl 2% solution for injection due to a lack of assurance of sterility. The recall affects 920 of the 10 mL syringes and 3,263 of the 5 mL syringes distributed to direct accounts. No incidents or injuries have been reported to date, but the manufacturer is initiating the recall to ensure patient safety.

Risk

A lack of sterility assurance means the medicine could be contaminated with bacteria or other pathogens. If an unsterile product is injected into the eye area (retrobulbar or peribulbar injection), it could cause serious, vision-threatening infections or other systemic illnesses.

What You Should Do

This recall affects Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection sold by Pine Pharmaceuticals in 10 mL and 5 mL prefilled syringes.
Identify your product by checking the Item number and lot numbers on the packaging. For the 10 mL syringe (Item# 803), check for lot 58366 (Exp 09/26/2022) or 60247 (Exp 12/04/2022). For the 5 mL syringe (Item# 933), check for lots 54825 (Exp 08/10/2022), 57583 (Exp 08/22/2022), 59343 (Exp 10/30/2022), or 60355 (Exp 10/11/2022).
Stop using the recalled product. Contact Pine Pharmaceuticals or your distributor immediately to arrange for the return of any remaining stock.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information about this recall or to report any adverse effects.

Your Remedy Options

Other Action

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

Affected Products

Product: Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection (10 mL)

Variants: 10 mL prefilled syringe, Item# 803

Model:

803

UPC Codes:

6919408031

Lot Numbers:

58366 (Exp 09/26/2022)

60247 (Exp 12/04/2022)

Quantity: 920 syringes

Product: Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection (5 mL)

Variants: 5 mL prefilled syringe, Item# 933

Model:

933

UPC Codes:

6919409331

Lot Numbers:

54825 (Exp 08/10/2022)

57583 (Exp 08/22/2022)

59343 (Exp 10/30/2022)

60355 (Exp 10/11/2022)

Quantity: 3263 syringes

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90854

Status: Resolved

Manufacturer: Pine Pharmaceuticals, LLC

Sold By: Direct accounts

Manufactured In: United States

Units Affected: a) 920 syringes; b) 3263 syringes

Distributed To: Alabama, California, North Carolina, New York

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 Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection sold by Pine Pharmaceuticals in 10 mL and 5 mL prefilled syringes.

Identify your product by checking the Item number and lot numbers on the packaging. For the 10 mL syringe (Item# 803), check for lot 58366 (Exp 09/26/2022) or 60247 (Exp 12/04/2022). For the 5 mL syringe (Item# 933), check for lots 54825 (Exp 08/10/2022), 57583 (Exp 08/22/2022), 59343 (Exp 10/30/2022), or 60355 (Exp 10/11/2022).

Stop using the recalled product. Contact Pine Pharmaceuticals or your distributor immediately to arrange for the return of any remaining stock.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information about this recall or to report any adverse effects.

Affected Products

Product: Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection (10 mL)

Variants: 10 mL prefilled syringe, Item# 803

Model:

803

UPC Codes:

6919408031

Lot Numbers:

58366 (Exp 09/26/2022)

60247 (Exp 12/04/2022)

Quantity: 920 syringes

Product: Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection (5 mL)

Variants: 5 mL prefilled syringe, Item# 933

Model:

933

UPC Codes:

6919409331

Lot Numbers:

54825 (Exp 08/10/2022)

57583 (Exp 08/22/2022)

59343 (Exp 10/30/2022)

60355 (Exp 10/11/2022)

Quantity: 3263 syringes