Pine Pharmaceuticals, LLC: Drug Recall

Recall #D-0130-2023 · 12/22/2022

Class II: Risk

Recall Details

Recall Number: D-0130-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Pine Pharmaceuticals, LLC
Status: Terminated
Date Initiated: 12/22/2022
Location: Tonawanda, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11,453 vials

Reason for Recall

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Product Description

Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1

Distribution Pattern

Nationwide to medical facilities.

Other Recalls by Pine Pharmaceuticals, LLC

Class II: Risk 10/02/2023

Lack of Assurance of Sterility
Class II: Risk 10/02/2023

Lack of Assurance of Sterility
Class II: Risk 10/02/2023

Lack of Assurance of Sterility
Class II: Risk 10/02/2023

Lack of Assurance of Sterility
Class II: Risk 10/02/2023

Lack of Assurance of Sterility

View all recalls by Pine Pharmaceuticals, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.