Drug 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.
D-0853-2020
Product summary
- Event
- Event 84927
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4600 Vials
- Official record key
drug-enforcement:D-0853-2020
Official wording
Reason: Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Code information: Lot #CGP190001-A, Exp. 07/31/2020
Distribution pattern: Ohio, Louisiana, Mississippi
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications