VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only;...
FDA Drug Recall #D-0281-2024 — Class I — December 28, 2023
Recall Summary
| Recall Number | D-0281-2024 |
| Classification | Class I — Serious risk |
| Date Initiated | December 28, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Denver Solutions, LLC DBA Leiters Health |
| Location | Englewood, CO |
| Product Type | Drugs |
| Quantity | 10,152 IV bags |
Product Description
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
Reason for Recall
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Distribution Pattern
Nationwide within the United States
Lot / Code Information
Lot #: 2331184, Exp. Date 02/13/2024; 2331185, Exp. Date 02/10/2024; 2331189, Exp. Date 02/20/2024; 2331191, Exp. Date 02/24/2024; 2331258,Exp. Date 03/03/2024; 2331317, Exp. Date 03/15/2024.
Other Recalls from Denver Solutions, LLC DBA Leiters Health
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0371-2025 | Class II | dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride... | Mar 31, 2025 |
| D-0373-2025 | Class II | Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL ... | Mar 31, 2025 |
| D-0370-2025 | Class II | Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Singl... | Mar 31, 2025 |
| D-0374-2025 | Class II | Rocuronium Bromide 50 mg per 5mL (10mg per mL),... | Mar 31, 2025 |
| D-0372-2025 | Class II | PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 ... | Mar 31, 2025 |
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.