Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk Parkway, Tonawanda, NY 14150.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #s: a) 58366, exp. date 09/26/2022; 60247, exp. date 12/04/2022; b) 54825, exp. date 08/10/2022; 57583, exp. date 08/22/2022; 59343, exp. date 10/30/2022; 60355, exp. date 10/11/2022
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Pine Pharmaceuticals, LLC
Reason for Recall:
Lack of Assurance of Sterility
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk Parkway, Tonawanda, NY 14150.

Product Codes/Lot Numbers:

Lot #s: a) 58366, exp. date 09/26/2022; 60247, exp. date 12/04/2022; b) 54825, exp. date 08/10/2022; 57583, exp. date 08/22/2022; 59343, exp. date 10/30/2022; 60355, exp. date 10/11/2022

Distribution:

Distributed in: AL, CA, NC, NY

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1514-2022

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