[pending] Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 C
Pending LLM rewrite. Source: FDA_DRUG D-0370-2025.
What this means for you
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: Pending LLM scoring against the rubric.
Plain-English summary
Lack of Assurance of Sterility: Leaking/damaged syringes.
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 — Drugs
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.
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