FDA Recall D-0487-2023
Apollo Care · Columbia, MO
Class II Ongoing 1191 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
Reason for recall
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Recall record
- Recall number
D-0487-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- MO
- Recall initiated
- 2023-02-08
- Classified by FDA Center
- 2023-03-24
- FDA published
- 2023-04-05
- Recalling firm
- Apollo Care
- Firm location
- Columbia, MO
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.