Apollo Care Fentanyl and Ropivacaine Epidural Injection Recalled for Contamination
Apollo Care is recalling 215 bags of Fentanyl and Ropivacaine epidural injection (Lot AC-016581) due to suspected microbial growth on external packaging. The recall affects product distributed in Missouri.
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 a sterile injectable product (epidural anesthetic) where sterility assurance is critical. Suspected microbial contamination poses an inherent risk of harm to patients; no illnesses or injuries have been reported, keeping the score at the maximum of 3 per the rubric rule for theoretical hazards without reported illness.
Plain-English summary
Apollo Care is recalling 215 bags of Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) in 250mL 0.9% Sodium Chloride solution, lot number AC-016581. The product is labeled for epidural use only.
The FDA initiated this Class II recall due to lack of assurance of sterility. Suspected microbial growth was detected on the external label packaging, raising concerns about the sterility of the product.
The recalled product was distributed in Missouri. Patients who have received this medication or healthcare providers who have this product in stock should consult with medical professionals regarding appropriate steps. If the product was administered, patients should report any signs of infection or unusual symptoms to their healthcare provider immediately.
The recalled product
- 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
- Manufacturer
- Apollo Care
- Category
- Drug — Epidural Anesthetic
- Affected units
- 215
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 (1)
- Lot #: AC-016581
Distribution
Distributed in 1 state:
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