Lidocaine HCl 4% ophthalmic solution recall: Sterility Concern
Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Why was Lidocaine HCl 4% ophthalmic solution recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 67443, Exp. Date 10/8/2023; 68775, Exp. Date 12/9/2023
- Product
- Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Recalling firm
- Pine Pharmaceuticals, LLC
- Quantity
- 1598 droppers
- Distribution
- Nationwide within the United States
- Recall date
- October 25, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)