Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct....

FDA Drug Recall #D-0614-2018 — Class II — March 7, 2018

Recall Summary

Recall Number D-0614-2018
Classification Class II — Moderate risk
Date Initiated March 7, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Apollo Care
Location Columbia, MO
Product Type Drugs
Quantity 144 bags

Product Description

Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.

Reason for Recall

Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.

Distribution Pattern

Medical Facility in MO

Lot / Code Information

Lot#: AC-015565, Exp. 03/26/2018

Other Recalls from Apollo Care

Recall # Classification Product Date
D-0487-2023 Class II Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 2... Feb 8, 2023
D-0277-2022 Class II VANComycin 1g added to 250mL of 0.9% Sodium Chl... Oct 28, 2021
D-0615-2018 Class II Vancomycin 1.25g added to 250 mL of 0.9% Sodium... Mar 7, 2018
D-0579-2018 Class II Vancomycin 1g added to 250mL of 0.9% Sodium Chl... Feb 15, 2018
D-0580-2018 Class II Vancomycin 1.25g added to 250mL of 0.9% Sodium ... Feb 15, 2018

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

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.