February 2020 FDA Recall Glycopyrrolate by Auromedics Pharma Llc
D-0853-2020 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Auromedics Pharma Llc on February 7, 2020 for the product Glycopyrrolate. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Ohio, Louisiana, Mississippi and the recall is currently terminated.

Recall Number: D-0853-2020

Reason for Recall
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Initiated
02-07-2020
Reported
02-26-2020
Quantity
4600 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84927
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AuroMedics Pharma LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Ohio, Louisiana, Mississippi
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-08-2023
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# CGP190001-A, Exp. 07/31/2020

Affected Packages Involved in this Recall

55150-292-01 Glycopyrrolate
55150-293-02 Glycopyrrolate
55150-294-05 Glycopyrrolate
55150-295-20 Glycopyrrolate