Why it was recalled
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide to medical facilities.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0130-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 22, 2022
- FDA report date
- Jan 11, 2023
- Quantity
- 11,453 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pine Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0130-2023, exactly as published.
Show all FDA fields
- City
- Tonawanda
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 91378
- Address
- 355 Riverwalk Pkwy
- 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.
- Postal code
- 14150-5837
- Report date
- Jan 11, 2023
- Product type
- Drugs
- Recall number
- D-0130-2023
- Classification
- Class II
- Recalling firm
- Pine Pharmaceuticals, LLC
- Product quantity
- 11,453 vials
- Termination date
- May 4, 2023
- Reason for recall
- CGMP Deviations: Raw material recalled by repackager, due to discoloration.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- Dec 22, 2022
- Initial firm notification
- Center classification date
- Jan 13, 2023