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.
What this means for you
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
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:
- AL
- LA
- MS
- TN
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