Agency classClass IIOur severity:High FDA (Drugs)·D-0028-2023·Announced 2022-11-09

FDA Recalls Vital Care Autologous Tears Serum Due to Sterility Assurance Failure

Vital Care Compounder's Autologous Tears Serum Full Strength has been recalled due to manufacturing defects that cannot assure product sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.

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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a lack of sterility assurance in a sterile pharmaceutical product, representing a risk of harm. Per the rubric, recalls involving risk-of-harm products where injury has not yet been reported receive a score of 3.

Plain-English summary

Vital Care Compounder is recalling Autologous Tears Serum Solution Full Strength, 3 mL droptainers (Rx only) due to manufacturing process defects. FDA inspection determined that the products were produced in a manner that cannot guarantee their sterility.

The recall includes 168 droptainers distributed in Alabama, Louisiana, Mississippi, and Tennessee. Affected lot numbers are 65521, 65545, 65605, 65658, 65733, 65894, 66019, 66120, 66388, 66755, 66870, and 66928, with beyond-use dates ranging from October 15 to November 19, 2022.

Patients who have received this product should consult their healthcare provider regarding the recall.

The recalled product

Product: AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Manufacturer: Pharmacy Plus, Inc. dba Vital Care Compounder
Category: Drug — Ophthalmic
Hazard: sterility-failure
Affected units: 168

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 (20)

Lots: 65521
BUD: 10/15/2022
65545
65605
BUD: 10/16/2022
65658
BUD: 10/17/2022
65733
BUD: 10/21/2022
65894
BUD: 10/24/2022
66019
BUD: 10/28/2022
66120
BUD: 10/30/2022
66388
BUD: 11/6/2022
66755
BUD: 11/14/2022
66870

Distribution

Distributed in 4 states:

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.

See all 32 products in this recall →

Same manufacturer · Pharmacy Plus, Inc. dba Vital Care Compounder

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Same hazard · sterility failure