Home / Recalls / Pine Pharmaceuticals, LLC / D-0060-2024

D-0060-2024 Class II Terminated

Recalled by Pine Pharmaceuticals, LLC — Tonawanda, NY

Recall Details

Product Type: Drugs
Report Date: October 25, 2023
Initiation Date: October 2, 2023
Termination Date: May 15, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1693 droppers

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 68184, Exp. Date 10/9/2023; 68623, Exp. Date 11/2/2023

Other recalls by Pine Pharmaceuticals, LLC

D-0056-2024 Class II — Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 (October 2, 2023)
D-0063-2024 Class II — Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-u (October 2, 2023)
D-0062-2024 Class II — Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compound (October 2, 2023)
D-0064-2024 Class II — Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administra (October 2, 2023)
D-0055-2024 Class II — Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL mu (October 2, 2023)
D-0057-2024 Class II — Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pha (October 2, 2023)
D-0059-2024 Class II — Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pin (October 2, 2023)
D-0051-2024 Class II — Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vi (October 2, 2023)
D-0061-2024 Class II — Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx o (October 2, 2023)
D-0052-2024 Class II — Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compo (October 2, 2023)