Epi-Caine — Class II drug recall D-0130-2023
Terminated recall by Pine Pharmaceuticals, LLC, reported 2023-01-11, distributed nationwide. CGMP Deviations: Raw material recalled by repackager, due to discoloration.
| Recall number | D-0130-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pine Pharmaceuticals, LLC, Tonawanda, NY, United States |
| Recall initiated | 2022-12-22 |
| Classified | 2023-01-13 |
| Reported by FDA | 2023-01-11 |
| Terminated | 2023-05-04 |
| Distributed | Nationwide (US) |
| Quantity | 11,453 vials |
| Reason classes | cgmp |
| NDC | 69194-0948-01 |
| Lot numbers | 62881, 62923, 63066, 63067, 63103, 63120, 63219, 63226, 63263, 63380, 63381, 63433, 63455, 63537, 63580, 63721, 63792, 63888, 63930, 63959, 64079, 64109, 64239 |
| Expiration dates | 2022-12-25, 2022-12-26, 2023-01-01, 2023-01-02, 2023-01-03, 2023-01-08, 2023-01-09, 2023-01-15, 2023-01-16, 2023-01-17, 2023-01-22, 2023-01-23, 2023-01-29, 2023-01-31, 2023-02-05, 2023-02-06, 2023-02-07, 2023-02-13, 2023-02-14, 2023-02-21 |
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
Reason for recall
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0130-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.