Recall D-0130-2023
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
Recall D-0130-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0130-2023 |
Event ID | 91378 |
Distribution | Nationwide to medical facilities. |
Quantity | 11,453 vials |
Recall Reason | CGMP Deviations: Raw material recalled by repackager, due to discoloration. |
Drug Classification | Class II |
Drug Code Info | 20230111 |
Recall Initiation Date | 20221222 |
Report Date | 20230111 |
Classification Date | 20230113 |
Address | 355 Riverwalk Pkwy Tonawanda, NY 14150-5837 United States |
Recalling Firm | Pine Pharmaceuticals, LLC |
Initial Notification | |
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