FDA Recalls Compounded Moxifloxacin Syringes for Lack of Sterility Assurance
Pine Pharmaceuticals recalls 2,176 syringes of compounded moxifloxacin nationwide due to inadequate sterility assurance. The product was distributed to healthcare providers and patients.
What this means for you
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 lack of sterility assurance in an injectable pharmaceutical. No illnesses or injuries are reported in the source text. Per the rubric, this constitutes a risk-of-harm product where injury has not been reported, warranting a High severity rating.
Plain-English summary
Pine Pharmaceuticals, LLC is recalling 2,176 syringes of Moxifloxacin in Balanced Salt Solution distributed nationwide. The affected lot numbers are 67623, 67919, 68917, 69079, and 69120, with expiration dates ranging from October 15, 2023, through December 24, 2023.
The FDA issued a Class II recall because the compounded medication lacks assured sterility. This means the product cannot be verified to be free from harmful microorganisms that could cause serious infections when injected. The product is distributed as prescription-only medication intended for injection.
Patients and healthcare providers who have syringes from the affected lots should stop using them immediately and consult their healthcare provider, particularly if any of the product has already been administered.
The recalled product
- Product
- Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Manufacturer
- Pine Pharmaceuticals, LLC
- Category
- Drug — Compounded Injectable
- Hazard
- lack-of-sterility
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 (10)
- Lot #: 67623
- Exp. Date 10/15/2023
- 67919
- Exp. Date 10/29/2023
- 68917
- Exp. Date 12/16/2023
- 69079
- Exp. Date 12/23/2023
- 69120
- Exp. Date 12/24/2023
Distribution
Distributed nationwide across the United States.
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