Drug recall D-0853-2020
Product
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.
Reason for recall
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Lots and codes
Lot #CGP190001-A, Exp. 07/31/2020
Recall details
- Recalling firm
- AuroMedics Pharma LLC, East Windsor, NJ
- Quantity
- 4600 Vials
- Distribution
- Ohio, Louisiana, Mississippi
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 7, 2020
- Terminated
- March 8, 2023
Related products
- Glycopyrrolate – drug information
- NDC 55150-293 Glycopyrrolate · Glycopyrrolate .2 mg/mL · AuroMedics Pharma LLC
- NDC 55150-292 Glycopyrrolate · Glycopyrrolate .2 mg/mL · AuroMedics Pharma LLC
- NDC 55150-295 Glycopyrrolate · Glycopyrrolate .2 mg/mL · AuroMedics Pharma LLC
- NDC 55150-294 Glycopyrrolate · Glycopyrrolate .2 mg/mL · AuroMedics Pharma LLC