Glycopyrrolate 1mg/5mL Syringes Recalled for Sterility Risk
Denver Solutions, LLC (DBA Leiters Health) is recalling Glycopyrrolate 1mg/5mL single-dose syringes (Lot #2431015B, expiration 4/10/2025) distributed nationwide because some syringes were found to be leaking or damaged, which compromises sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with potential for contamination and loss of sterility assurance in an injectable drug product. While no illnesses or injuries are reported in the source, the risk-of-harm nature of compromised sterility in a parenteral medication without reported adverse events justifies a High rating per the rubric.
Plain-English summary
Denver Solutions, LLC (DBA Leiters Health) is recalling Glycopyrrolate 1mg/5mL (0.2 mg/mL) in single-dose 5mL syringes (NDC 71449-104-11) distributed nationwide in the United States. The recall affects 170 syringes from Lot #2431015B with an expiration date of 4/10/2025.
The syringes are being recalled because some units are leaking or damaged, which creates a lack of assurance of sterility. Damaged or leaking syringes cannot be guaranteed to remain sterile and may pose a risk if administered to patients.
Patients or healthcare facilities using syringes from the affected lot should stop use and contact Denver Solutions, LLC (DBA Leiters Health) at 13796 Compark Blvd, Englewood, CO 80112 for further instructions. Patients should consult with their healthcare provider if they have questions about their treatment.
The recalled product
- Product
- Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Category
- Drug
- Affected units
- 170
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 (2)
- Lot #: 2431015B
- Exp. 4/10/2025.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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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