Food, drugs, devices › Pine Pharmaceuticals, LLC
Drug recall: Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 River
FDA enforcement event 93154 is a drug recall by Pine Pharmaceuticals, LLC of Tonawanda, NY, initiated 2 Oct 2023 and classified Class II, with 16 product records.
FDA defines Class II as 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. 59% of the 281 drug enforcement events initiated in 2023 carry the same class.
Status: Terminated, terminated 15 May 2024. Initiation: voluntary: firm initiated. Pine Pharmaceuticals, LLC has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Pine Pharmaceuticals, LLC, Tonawanda, NY.
Reason for recall
"Lack of Assurance of Sterility"
Distribution
"Nationwide within the United States"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0050-2024 | Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 2862 Syringes | Class II | Terminated | 25 Oct 2023 |
| D-0051-2024 | Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 26 vials | Class II | Terminated | 25 Oct 2023 |
| D-0052-2024 | Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 201 kits | Class II | Terminated | 25 Oct 2023 |
| D-0053-2024 | Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 128 bags | Class II | Terminated | 25 Oct 2023 |
| D-0054-2024 | Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 881 pre-filled syringes | Class II | Terminated | 25 Oct 2023 |
| D-0055-2024 | Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 2181 droppers | Class II | Terminated | 25 Oct 2023 |
| D-0056-2024 | Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 2484 syringes | Class II | Terminated | 25 Oct 2023 |
| D-0057-2024 | Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 4972 syringes | Class II | Terminated | 25 Oct 2023 |
| D-0058-2024 | Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 2176 syringes | Class II | Terminated | 25 Oct 2023 |
| D-0059-2024 | Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 9673 vials | Class II | Terminated | 25 Oct 2023 |
| D-0060-2024 | TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 1693 droppers | Class II | Terminated | 25 Oct 2023 |
| D-0061-2024 | Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 130 | Class II | Terminated | 25 Oct 2023 |
| D-0062-2024 | Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 1598 droppers | Class II | Terminated | 25 Oct 2023 |
| D-0063-2024 | Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 662 dropper | Class II | Terminated | 25 Oct 2023 |
| D-0064-2024 | Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 860 syringes | Class II | Terminated | 25 Oct 2023 |
| D-0065-2024 | Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | 136 syringes | Class II | Terminated | 25 Oct 2023 |
Context
Other enforcement events for Pine Pharmaceuticals, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Mar 2023 | Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in indiv | Drug | Class III | 1 |
| 22 Dec 2022 | Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded | Drug | Class II | 1 |
| 27 Jul 2022 | Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 | Drug | Class II | 1 |
| 5 Mar 2018 | Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy | Drug | Class III | 1 |
| 4 Nov 2015 | Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods | Drug | Class II | 4 |
All 6 events for Pine Pharmaceuticals, LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Lack of Assurance of Sterility"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within the United States"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 May 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.