Lidocaine eye drops recalled due to lack of sterility assurance
Pine Pharmaceuticals is recalling Lidocaine HCl 4% ophthalmic solution due to lack of sterility assurance. The affected product was distributed nationwide in 1,598 single-use droppers.
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: This is an FDA Class II recall for a pharmaceutical product with lack of sterility assurance. Although no illnesses, injuries, or hospitalizations have been reported in the source text, non-sterile ophthalmic solutions pose a significant risk of harm through potential eye infections or contamination. This qualifies as a risk-of-harm product without reported injury per the severity rubric.
Plain-English summary
Pine Pharmaceuticals, LLC is recalling Lidocaine HCl 4% ophthalmic solution (eye drops) due to lack of assurance of sterility. The recalled product is supplied as 3 mL single-use droppers for prescription use.
The recall affects 1,598 droppers distributed nationwide. The recalled lots are Lot #67443 (expiration date 10/8/2023) and Lot #68775 (expiration date 12/9/2023). The product was manufactured and compounded by Pine Pharmaceuticals, LLC in Tonawanda, New York.
Lack of sterility assurance in eye drops poses a potential risk for eye infections or other contamination-related adverse effects. Patients currently using affected droppers should contact their healthcare provider immediately. Do not use the recalled product and follow your healthcare provider's instructions for obtaining a replacement.
The recalled product
- Product
- Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Manufacturer
- Pine Pharmaceuticals, LLC
- Affected units
- 1,598
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 (4)
- Lot #: 67443
- Exp. Date 10/8/2023
- 68775
- Exp. Date 12/9/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Pine Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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