AuroMedics Pharma LLC recalls Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra…

Recall date

February 7, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0853-2020

FDA classification

Class III

Brand / firm

AuroMedics Pharma LLC

Sold / distributed

Ohio, Louisiana, Mississippi

Why it was recalled

Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.