Glycopyrrolate recall: Sterility Concern
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
Why was Glycopyrrolate recalled?
Lack of Assurance of Sterility: Leaking/damaged syringes.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 2431015B, Exp. 4/10/2025.
- 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
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Quantity
- 170 syringes
- Distribution
- Nationwide in the U.S.A
- Recall date
- April 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)