Drug Enforcement D-0056-2024

Lack of Assurance of Sterility

Status

Terminated

Classification

Class II

Report Date

October 25, 2023

Termination Date

May 15, 2024

Product Information

Product description
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.
Product quantity
2484 syringes
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Pine Pharmaceuticals, LLC
Address
355 Riverwalk Pkwy, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0056-2024
Event ID
93154
Recall initiation date
October 2, 2023
Center classification date
October 19, 2023
Code info
Lot #: 67480, Exp. Date 10/9/2023; 68640,Exp. Date 12/3/2023; 68769, Exp. Date 12/9/2023; 68760, Exp. Date 12/10/2023; 68925, Exp. Date 12/16/2023;70119, Exp. Date 1/20/2024
More code info