Recalls / Class II
Class IID-0130-2023
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
- Affected lot / code info
- 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.
Why it was recalled
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Recalling firm
- Firm
- Pine Pharmaceuticals, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 355 Riverwalk Pkwy, N/A, Tonawanda, New York 14150-5837
Distribution
- Quantity
- 11,453 vials
- Distribution pattern
- Nationwide to medical facilities.
Timeline
- Recall initiated
- 2022-12-22
- FDA classified
- 2023-01-13
- Posted by FDA
- 2023-01-11
- Terminated
- 2023-05-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0130-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.