Fresenius Kabi USA, LLC: Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Fresenius Kabi USA, LLC
- Product
- Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07
- Reason / hazard
- Presence of Particulate Matter: Hair was found in product
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within in the USA
- Recall initiated
- 2026-07-16
- Code info
- Lot #: 6134349, 6134620 Exp. Date 11/2026
- Product quantity
- 59,425 vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Lake Zurich
- State
- IL
- Country
- United States
- Event id
- 99449
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