D-0853-2020 Class III Terminated
FDA drug recall D-0853-2020 was initiated by AuroMedics Pharma LLC on February 7, 2020 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples). The recall status is terminated (terminated March 8, 2023). Affected quantity: 4600 Vials.
Recall Details
- Product Type
- Drugs
- Report Date
- February 26, 2020
- Initiation Date
- February 7, 2020
- Termination Date
- March 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4600 Vials
Product Description
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).
Distribution Pattern
Ohio, Louisiana, Mississippi
Code Information
Lot #CGP190001-A, Exp. 07/31/2020