Glycopyrrolate Tablets recalled over possible glass fragments

Recall date

March 17, 2022

Source

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

Official notice title

Aurolife Pharma, LLC recalls Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton…

Recall number

D-0736-2022

FDA classification

Class II

Brand / firm

Aurolife Pharma, LLC

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.