FDAFDA · Food and drugs·Recall number D-0853-2020
Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for Use in Newborns, Contains Benzyl Alcohol, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ, 08520, Made in India, NDC 55150-295-20.
Published February 26, 2020 · Recall initiated: February 7, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- GLYCOPYRROLATE
- Manufacturer
- AuroMedics Pharma LLC
- Distributor
- Ohio, Louisiana, Mississippi
- UPC
- 0355150295203
- Lot
- Lot #CGP190001-A, Exp. 07/31/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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