Intraocular Moxifloxacin Injection Recalled Due to Sterility Assurance Issues
Pine Pharmaceuticals is recalling 2,484 syringes of Moxifloxacin intraocular injection nationwide due to lack of sterility assurance in the compounded product.
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 without reported hospitalizations or illnesses. The hazard—lack of sterility assurance in an intraocular injection administered directly into the eye—poses a risk of serious infection, but no actual harm has been reported. Per the rubric, risk-of-harm products where injury has not been reported score as High (3).
Plain-English summary
Pine Pharmaceuticals, LLC is recalling 2,484 syringes of Moxifloxacin in Balanced Salt Solution (600 mcg/0.4mL or 150 mcg/0.1mL strength). This is a prescription intraocular injection used to treat bacterial infections of the eye. The recall was initiated due to lack of assurance of sterility in the compounded product.
The recalled product was distributed nationwide within the United States. Affected lot numbers and expiration dates are: 67480 (10/9/2023), 68640 (12/3/2023), 68769 (12/9/2023), 68760 (12/10/2023), 68925 (12/16/2023), and 70119 (1/20/2024). The product was compounded by Pine Pharmaceuticals, located at 355 Riverwalk Parkway, Tonawanda, NY 14150.
Patients and healthcare providers who have received or dispensed this product should immediately discontinue use. If a patient has already received any of the recalled syringes, they should contact their healthcare provider to report potential exposure and discuss appropriate follow-up care. The product should be returned to the dispensing pharmacy.
The recalled product
- Product
- Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Manufacturer
- Pine Pharmaceuticals, LLC
- Affected units
- 2,484
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 (12)
- Lot #: 67480
- Exp. Date 10/9/2023
- 68640
- Exp. Date 12/3/2023
- 68769
- Exp. Date 12/9/2023
- 68760
- Exp. Date 12/10/2023
- 68925
- Exp. Date 12/16/2023
- 70119
- Exp. Date 1/20/2024
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.
See all 16 products in this recall →Related recalls
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