Vancomycin HCI IV bags recalled for labeling issue
Denver Solutions is recalling 33,480 Vancomycin HCI IV bags (NDC 71449-028-68) due to a labeling issue. The affected lots were distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses, injuries, or deaths. The stated issue is a labeling problem. Per the rubric, FDA Class III recalls are typically scored 1 or 2, and this qualifies as a 'minor labeling error' at severity level 2.
Plain-English summary
Denver Solutions, LLC, is recalling 33,480 Vancomycin HCI PF 1.25 g in 0.9% Sodium Chloride 250 mL IV bags (NDC 71449-028-68) due to a labeling issue. The product was manufactured by Leiters Compounding Health at 13796 Compark Blvd, Englewood, Colorado.
The recall involves a labeling classification issue. The specific nature of the labeling defect is not detailed in the available FDA recall information.
The affected product was distributed nationwide. Affected lot numbers include 2330781, 2330791, 2330795, 2330800, 2330807, 2330812, 2330816, 2330822, 2330897, 2330899, 2330901, 2330918, 2330943, 2331050, 2331064, and 2331102, with expiration dates ranging from October 2023 to January 2024.
Healthcare facilities and pharmacies that received affected lots should consult the FDA website or contact Denver Solutions for guidance on product handling and replacement.
The recalled product
- Product
- VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Category
- Drug — Antibiotic / Injectable
- Hazard
- Affected units
- 33,480
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#: 2330781
- Exp. 10/19/23
- 2330791
- Exp. 10/29/23
- 2330795
- Exp. 11/02/23
- 2330800
- Exp. 11/09/23
- 2330807
- Exp. 11/11/23
- 2330812
- Exp. 11/16/23
- 2330816
- Exp. 11/19/23
- 2330822
- 10/20/23
- 2330897
- 11/23/23
- 2330899
- 11/25/23
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Denver Solutions, LLC DBA Leiters Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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