The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1533-2016·Announced 2016-10-05

FDA Recalls Vital Care Compounder Eye Drops for Sterility Concerns

The FDA is recalling specific lots of MOXI/DEX/KETOROLAC eye drops from Vital Care Compounder 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 source text identifies the recall as FDA Class II. According to the severity rubric, an FDA Class II recall is classified as Severe (Score 4), particularly given the risk of infection associated with a lack of sterility assurance in ophthalmic products.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4% eye drops, product number #15, manufactured by Pharmacy Plus, Inc. dba Vital Care Compounder in Hattiesburg, Mississippi. The recall is being conducted because the agency has identified a lack of assurance of sterility for the affected product.

The recall involves six vials of the medication. The specific lots affected are 399080 (use by 8-14-16), 399740 (use by 8-25-16), 398952 (use by 8-13-16), 398865 (use by 8-11-16), 399057 (use by 8-13-16), and 398864 (use by 8-11-16). The source text indicates that the product was distributed in Mississippi.

Consumers and healthcare providers should stop using the affected lots of this medication and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402
Manufacturer
Pharmacy Plus, Inc. dba Vital Care Compounder
Category
Drug — Ophthalmic
Hazard
Affected units
6

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#: 399080
  • Use by 8-14-16
  • 399740
  • Use by 8-25-16
  • 398952
  • Use by 8-13-16
  • 398865
  • Use by 8-11-16
  • 399057
  • 398864

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 →

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