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.
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 1/5 (Low).
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
- Category
- Drug — Intravenous
- Hazard
- Affected units
- 25,908
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.
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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