CLASS II Drug recall · Reported 25 Oct 2023 · FDA Enforcement Report
Cefuroxime 4mg / (10 mg/mL) syringe recalled by Pine Pharmaceuticals
Pine Pharmaceuticals is recalling Cefuroxime 4mg / (10 mg/mL) syringe, distributed nationwide in the US. The recall was initiated on 2 Oct 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0057-2024
- FDA event ID
- 93154
- Recalling firm
- Pine Pharmaceuticals, Tonawanda, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Oct 2023
- FDA classified
- 19 Oct 2023
- Reported
- 25 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Compounded Drugs
Timeline
| 2 Oct 2023 | Recall initiated by company | |
| 19 Oct 2023 | Classified by FDA | +17 days |
| 25 Oct 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
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; 71068, Exp. Date 3/9/2024; 67345, Exp. Date 10/3/2023
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
15 other products · FDA event 93154This product is part of a recall event; the main page for the event is Lidocaine-phenylephrine 1%-1.5% Single Dose Vial recalled.
More recalls from Pine Pharmaceuticals
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Foscarnet Sodium 2.4mg/ solution recalled by Pine Pharmaceuticals | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Endophth Kit (Vancomycin 1mg/ - Ceftazidime 2.25mg recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Bevacizumab 1.25 MG/ Solution for Injection syringes recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic recalled | Pine Pharmaceuticals | Sterility | Nationwide |
Other Cefuroxime recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cefuroxime, Sterile Ophthalmic Solution for Injection recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Cefuroxime 10mg/mL INJ 0.5 mg, SDV recalled | Pacific Compounding Pharmacy & Consultations | Particulate Matter | CA |
| Drug | CLASS II | Cefuroxime 10 mg/mL in Sodium Chloride recalled by Leiter's Enterprises | Leiter's Enterprises | Sterility | 4 states |
| Drug | CLASS III | Cefuroxime, Ophthalmic Solution for Injection recalled | JCB Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride recalled | Leiter's Compounding | Sterility | Nationwide |