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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 4,972
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.
Part of a larger recall action
This product is one of 16 recalled by Pine Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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