Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded
Summary
The FDA issued a Class II for Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injec by Pine Pharmaceuticals, LLC. Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration..
Details
Source
Drug Recall
External ID
D-0130-2023
Action Date
2023-01-11
Status
Terminated
Category
drug
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/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.
Quantity Affected: 11,453 vials
Reason for Recall
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Distribution
Nationwide to medical facilities.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-22
Company
Tonawanda, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 22 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Pine Pharmaceuticals, LLC has 19 FDA actions in our database, including 19 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pine Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pine Pharmaceuticals, LLC have FDA actions?
Pine Pharmaceuticals, LLC has 19 FDA actions in our database, including 19 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0130-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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