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Recall Observatory FDA recall evidence

Drug product

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

D-0130-2023

December 22, 2022

Class II

Product summary

Firm
Pine Pharmaceuticals, LLC
Event
Event 91378
Status
Terminated
Classification
Class II
Quantity
11,453 vials
Official record key
drug-enforcement:D-0130-2023

Official wording

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

Code information: Lot # 62881, Exp 12/25/2022; 62923, Exp 12/26/2022; 63066, Exp 01/03/2023; 63067, Exp 01/01/2023; 63103, Exp 01/02/2023; 63120, Exp 01/03/2023; 63219, 63226, Exp 01/08/2023; 63263, Exp 01/09/2023; 63380, 63381, Exp 01/15/2023; 63433, Exp 01/16/2023; 63455, Exp 01/17/2023; 63537, Exp 01/22/2023; 63580, Exp 01/23/2023; 63721, Exp 01/29/2023; 63792, Exp 01/31/2023; 63888, Exp 02/05/2023; 63930, Exp 02/06/2023; 63959, Exp 02/07/2023; 64079, Exp 02/13/2023; 64109, Exp 02/14/2023; 64239, Exp 02/21/2023.

Distribution pattern: Nationwide to medical facilities.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations