Compounded Intranasal Lidocaine-Oxymetazoline Solution Recalled Due to Sterility Assurance
Pine Pharmaceuticals is recalling 860 syringes of intranasal lidocaine-oxymetazoline solution distributed nationwide due to lack of sterility assurance. Lot 67808 expired 10/23/2023.
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 FDA Class II recall addresses a compounded intranasal medication with lack of sterility assurance. No illnesses or injuries have been reported, so this qualifies as a high-risk situation where potential for harm exists but injury has not yet been documented.
Plain-English summary
Pine Pharmaceuticals is recalling 860 syringes of its compounded intranasal solution (lidocaine HCL 2% and oxymetazoline HCl 0.025%). The product is supplied in 2-mL syringes for intranasal use (Rx only) and was distributed nationwide.
The FDA classified this as a Class II recall due to lack of assurance of sterility. This means the compounded medication cannot be verified to meet sterility standards required for intranasal medications.
The recall affects Lot #67808, which expired on 10/23/2023. The product was manufactured by Pine Pharmaceuticals, LLC (Tonawanda, NY).
The recalled product
- Product
- Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Manufacturer
- Pine Pharmaceuticals, LLC
- Hazard
- Affected units
- 860
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 (2)
- Lot #: 67808
- Exp. Date 10/23/2023
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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