The Recall Desk
HighFDA (Drugs)·D-0057-2024·Announced 2023-10-25

Cefuroxime Injectable Syringes Recalled for Lack of Sterility Assurance

Pine Pharmaceuticals is recalling 4,972 syringes of Cefuroxime injectable medication due to lack of assurance of sterility. The compounded antibiotic was distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall of a sterile compounded injectable medication with lack of sterility assurance meets the rubric criterion for Score 3: a risk-of-harm product where injury has not yet been reported. No illnesses or deaths are documented in the source material.

Plain-English summary

Pine Pharmaceuticals, LLC is recalling Cefuroxime 4mg/0.4 mL injectable syringes due to lack of assurance of sterility. The compounded antibiotic was manufactured by Pine Pharmaceuticals in Tonawanda, New York, and may not meet established sterilization standards.

The recall affects approximately 4,972 syringes that were distributed nationwide. The affected product is prescribed by healthcare providers for injectable antibiotic treatment.

Healthcare facilities and patients who have received this medication should stop using it immediately and contact their healthcare provider or supplier. Those with questions about the recall should contact Pine Pharmaceuticals at 355 Riverwalk Parkway, Tonawanda, NY 14150.

Affected lot numbers include: 67918 (Exp. 10/29/2023), 68033 (Exp. 11/4/2023), 68515 (Exp. 11/26/2023), 68528 (Exp. 11/27/2023), 68618 (Exp. 12/2/2023), 68651 (Exp. 12/3/2023), 68767 (Exp. 12/9/2023), 68829 (Exp. 12/11/2023), 69820 (Exp. 1/9/2024), 70733 (Exp. 2/19/2024), 71068 (Exp. 3/9/2024), 67345 (Exp. 10/3/2023).

The recalled product

Product
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Manufacturer
Pine Pharmaceuticals, LLC
Category
Drug — Compounded Injectable / Antibiotic
Hazard
  • contamination
  • sterility-assurance
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #: 67918
  • Exp. Date 10/29/2023
  • 68033
  • Exp. Date 11/4/2023
  • 68515
  • Exp. Date 11/26/2023
  • 68528
  • Exp. Date 11/27/2023
  • 68618
  • Exp. Date 12/2/2023
  • 68651
  • Exp. Date 12/3/2023
  • 68767
  • Exp. Date 12/9/2023
  • 68829
  • Exp. Date 12/11/2023
  • 69820
  • Exp. Date 1/9/2024
  • 70733
  • Exp. Date 2/19/2024

Distribution

Distributed nationwide across the United States.

Related recalls

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