Home / Recalls / Pine Pharmaceuticals, LLC / D-0063-2024

D-0063-2024 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
662 dropper

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 67659, Exp. Date 10/16/2023; 70316, Exp. Date 1/30/2024

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-0052-2024 Class II — Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compo (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-0050-2024 Class II — Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Comp (October 2, 2023)