The Recall Desk
LowFDA (Drugs)·D-0072-2024·Announced 2023-11-01

Vancomycin Hydrochloride IV Bags Recalled Nationwide for Labeling Issue

Denver Solutions, LLC is recalling 25,908 Vancomycin HCI IV bags distributed nationwide due to a labeling issue. Affected lots include products with expiration dates from October 2023 through January 2024.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: FDA Class III pharmaceutical recall with no reported illnesses or injuries; the specific labeling defect is not disclosed, consistent with documentation issues typically rated as Low per the recall severity rubric.

Plain-English summary

Denver Solutions, LLC DBA Leiters Health is recalling VANCOmycin HCI PF 1.5g in 0.9% Sodium Chloride 250 mL intravenous bags due to a labeling issue. The recall affects 25,908 IV bags distributed nationwide to healthcare facilities.

The affected products bear lot numbers 2330792, 2330801, 2330821, 2330823, 2330825, 2330846, 2330847, 2330856, 2330858, 2330860, 2330866, and 2331053, with expiration dates between October 2023 and January 2024. Healthcare facilities and patients who have received affected lots should contact Denver Solutions, LLC or their healthcare provider for instructions on managing this recall.

The recalled product

Product
VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.
Manufacturer
Denver Solutions, LLC DBA Leiters Health
Hazard
  • mis-labeling

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 (20)

  • Lot#: 2330792
  • Exp. 12/17/23
  • 2330801
  • Exp. 12/26/23
  • 2330821
  • 10/15/23
  • 2330823
  • Exp. 10/21/23
  • 2330825
  • Exp. 10/27/23
  • 2330846
  • Exp. 10/28/23
  • 2330847
  • Exp. 11/03/23
  • 2330856
  • 11/17/23
  • 2330858
  • Exp. 12/03/23
  • 2330860
  • 12/15/23

Distribution

Distributed nationwide across the United States.