Vital Care Compounder Recalls Moxifloxacin HCl Eye Drops for Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 16 vials of Moxifloxacin HCl eye drops due to a lack of assurance of 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for serious health consequences (such as sterility issues in ophthalmic products) fall under the Severe category.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 16 vials of Moxifloxacin HCl 1 mg/ml and BSS solution. The product is a 2ml single-use vial prescription medication. The recall is being conducted because of a lack of assurance of sterility.
The affected product is identified by Lot# 396607 with a use-by date of 08/13/16. The distribution pattern is listed as MS, indicating the product was distributed in Mississippi. The recalling firm is located in Hattiesburg, MS.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II.
The recalled product
- Product
- Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial, Rx, Vital Care Compounder, Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 16
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# 396607
- Use by 08/13/16
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 21 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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