CLASS II Drug recall · Reported 11 Jan 2023 · FDA Enforcement Report
Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution recalled
Pine Pharmaceuticals is recalling Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, distributed nationwide in the US. The recall was initiated on 22 Dec 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0130-2023
- FDA event ID
- 91378
- Recalling firm
- Pine Pharmaceuticals, Tonawanda, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Dec 2022
- FDA classified
- 13 Jan 2023
- Reported
- 11 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 22 Dec 2022 | Recall initiated by company | |
| 11 Jan 2023 | Published in enforcement report | +20 days |
| 13 Jan 2023 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Product as listed by the FDA
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
Where it was distributed
Nationwide to medical facilities.
Questions about this recall
Why was it recalled?
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Which lots are affected?
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 was it sold?
Nationwide to medical facilities.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pine Pharmaceuticals
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Foscarnet Sodium 2.4mg/ solution recalled by Pine Pharmaceuticals | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Endophth Kit (Vancomycin 1mg/ - Ceftazidime 2.25mg recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Bevacizumab 1.25 MG/ Solution for Injection syringes recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic recalled | Pine Pharmaceuticals | Sterility | Nationwide |