The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1541-2016·Announced 2016-10-05

FDA Recalls Autologous Serum Tears Due to Sterility Assurance Concerns

The FDA is recalling Autologous Serum Tears from Vital Care Compounder due to a lack of assurance of sterility. The product was distributed in Mississippi.

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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility assurance in a medical product falls under the 'Severe' category (Score 4), particularly when structural or safety defects are present without confirmed fatalities.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Autologous Serum Tears, a prescription product manufactured by Pharmacy Plus, Inc. dba Vital Care Compounder in Hattiesburg, Mississippi. The recall was initiated because of a lack of assurance of sterility in the product.

The affected product consists of 2 vials per bottle, with a total of 8 bottles involved in this recall. The distribution was limited to the state of Mississippi. Specific lot numbers and use-by dates are listed in the official recall notice, including lots 390325, 382789, 396766, 393470, 393036, 398131, 389288, and 392969.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication. The FDA classifies this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Manufacturer
Pharmacy Plus, Inc. dba Vital Care Compounder
Category
Drug — Ophthalmic
Hazard
Affected units
8

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 (15)

  • Lot#: 390325
  • Use by 08/01/16
  • 382789
  • Use by 08/07/16
  • 396766
  • Use by 08/11/16
  • 393470
  • Use by 08/14/16
  • 393036
  • 398131
  • Use by 08/15/16
  • 389288
  • Use by 08/20/16
  • 392969
  • Use by 08/21/16

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 →

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