Recalls / Class II
Class IID-0032-2023
Product
CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Affected lot / code info
- Lots: 59638, BUD: 11/25/2022; 64261, BUD: 04/30/2023
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.
Recalling firm
- Firm
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 115 S 40th Ave, N/A, Hattiesburg, Mississippi 39402-6600
Distribution
- Quantity
- 67 bottles
- Distribution pattern
- AL, LA, MS, and TN
Timeline
- Recall initiated
- 2022-10-07
- FDA classified
- 2022-11-02
- Posted by FDA
- 2022-11-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0032-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.