Apollo Care Fentanyl and Ropivacaine HCl added to Recall

Why it was recalled

Lack of assurance of sterility: Suspected microbial growth present on external label packaging.

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: AC-016581

Where it was sold

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-0487-2023
Classification: Class II
Status: Ongoing
Recall initiated: Feb 8, 2023
FDA report date: Apr 5, 2023
Quantity: 215 bags
Recall type: Voluntary: Firm initiated
Recalling firm: Apollo Care

Original FDA data

Every field from FDA enforcement report D-0487-2023, exactly as published.

Show all FDA fields

City: Columbia
State: MO
Status: Ongoing
Country: United States
Event ID: 91674
Address: 3801 Mojave Ct Ste 101
Code information: Lot #: AC-016581
Postal code: 65202-4042
Report date: Apr 5, 2023
Product type: Drugs
Recall number: D-0487-2023
Classification: Class II
Recalling firm: Apollo Care
Product quantity: 215 bags
Reason for recall: Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: MO
Recall initiation date: Feb 8, 2023
Initial firm notification: E-Mail
Center classification date: Mar 24, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0487-2023, published Apr 5, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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Apollo Care Fentanyl 500mcg Recall

Summary