VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 38...

FDA Drug Recall #D-0639-2023 — Class II — May 2, 2023

Recall Summary

Recall Number D-0639-2023
Classification Class II — Moderate risk
Date Initiated May 2, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Apollo Care, LLC
Location Columbia, MO
Product Type Drugs
Quantity 1113 bags

Product Description

VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-264-25

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Missouri only

Lot / Code Information

Lot #: AC-016647, Exp. Date 06/28/2023

Other Recalls from Apollo Care, LLC

Recall # Classification Product Date
D-0409-2025 Class II FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 2... Apr 15, 2025
D-0646-2023 Class II FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL ... May 2, 2023
D-0635-2023 Class II Ketamine Injection, 50 mg per 5 mL (10 mg/mL), ... May 2, 2023
D-0647-2023 Class II VANComycin 1.5g added to 250 mL of 0.9% Sodium ... May 2, 2023
D-0643-2023 Class II VANComycin 2.5 g added to 500 mL of 0.9% Sodium... May 2, 2023

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.