Epi-Caine Intraocular Injection Recalled Due to Raw Material Discoloration
Pine Pharmaceuticals is recalling Epi-Caine intraocular injection (11,453 vials nationwide) due to discoloration in raw material used for compounding, a manufacturing quality control failure.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification with identified manufacturing deviation (discoloration in raw material). While no illnesses or injuries have been reported, this represents a risk-of-harm situation for an injectable pharmaceutical where quality control failure could result in product contamination or safety issues.
Plain-English summary
Pine Pharmaceuticals is recalling Epi-Caine, a sterile intraocular injection containing epinephrine 0.025% and lidocaine HCL 0.75%. The recall involves 11,453 single-dose vials that were distributed nationwide to medical facilities.
The recall was triggered by a manufacturing deviation: discoloration was detected in the raw material used to compound the product. This indicates a breakdown in manufacturing quality control standards (Current Good Manufacturing Practices).
Healthcare providers who received affected lots should immediately stop using the product and contact Pine Pharmaceuticals for return or destruction instructions. Affected lots are identified by lot numbers ranging from #62881 to #64239, with expiration dates between December 2022 and February 2023.
The recalled product
- 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
- Manufacturer
- Pine Pharmaceuticals, LLC
- Affected units
- 11,453
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- 63219
- 63226
- Exp 01/08/2023
- 63263
- Exp 01/09/2023
- 63380
- 63381
- Exp 01/15/2023
- 63433
Distribution
Distributed nationwide across the United States.
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