Why it was recalled
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Product description
AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Lot numbers, UPCs & expiration codes
Lots: 65521, BUD: 10/15/2022; 65545, BUD: 10/15/2022; 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, UD: 11/18/2022; 66928, BUD: 11/19/2022
Where it was sold
AL, LA, MS, and TN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0028-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 7, 2022
- FDA report date
- Nov 9, 2022
- Quantity
- 168 droptainers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmacy Plus, Inc. dba Vital Care Compounder
Original FDA data
Every field from FDA enforcement report D-0028-2023, exactly as published.
Show all FDA fields
- City
- Hattiesburg
- State
- MS
- Status
- Ongoing
- Country
- United States
- Event ID
- 90982
- Address
- 115 S 40th Ave
- Code information
- Lots: 65521, BUD: 10/15/2022; 65545, BUD: 10/15/2022; 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, UD: 11/18/2022; 66928, BUD: 11/19/2022
- Postal code
- 39402-6600
- Report date
- Nov 9, 2022
- Product type
- Drugs
- Recall number
- D-0028-2023
- Classification
- Class II
- Recalling firm
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Product quantity
- 168 droptainers
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Distribution pattern
- AL, LA, MS, and TN
- Recall initiation date
- Oct 7, 2022
- Initial firm notification
- Telephone
- Center classification date
- Nov 2, 2022