The Recall Desk
SevereFDA (Drugs)·D-1538-2016·Announced 2016-10-05

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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.

See all 21 products in this recall →