Class III
Terminated
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.
- Company
- Auromedics Pharma Llc
- Recall Initiated
- February 7, 2020
- Posted
- February 26, 2020
- Recall Number
- D-0853-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4600 Vials
- Firm Location
- East Windsor, NJ, United States
Reason for Recall
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Distribution
Ohio, Louisiana, Mississippi
Lot / Code Info
Lot #CGP190001-A, Exp. 07/31/2020
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