Moxifloxacin Preservative-Free Eye Drops Recalled for Sterility Assurance Failure
Pharmacy Plus, Inc. is recalling Moxifloxacin 0.15 mg/0.1 mL preservative-free eye drops in 1 mL syringes due to lack of assured sterility. FDA inspection found the manufacturing process could not guarantee the product's sterility.
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: FDA Class II recall where the manufacturing defect (lack of sterility assurance) presents a significant risk of infection for a sterile injectable product; however, no illnesses or injuries have been reported.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Moxifloxacin Preservative Free Syringes, 0.15 mg/0.1 mL, sterile solution in 1 mL syringes. The recall affects Lot 66470 with a Beyond Use Date of November 10, 2022. FDA inspection determined that the recalled products were manufactured in a manner that cannot guarantee the sterility of products labeled as sterile.
The recalled syringes were distributed to pharmacies and healthcare facilities in Alabama, Louisiana, Mississippi, and Tennessee. A total of 106 syringes were distributed. Moxifloxacin is an antibiotic eye drop used to treat bacterial eye infections.
Patients and healthcare providers who have these syringes should stop using them immediately and contact Vital Care Compounder or their pharmacy for instructions. Any concerns about potential adverse effects should be reported to the FDA's MedWatch program or to your healthcare provider.
The recalled product
- Product
- MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Ophthalmic
- Affected units
- 106
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: 66470
- BUD: 11/10/2022
Distribution
Part of a larger recall action
This product is one of 32 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder 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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