FDA-Drug2022-04-06Class II

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.

Aurolife Pharma, LLC
Hazard

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

Sold states
Nationwide in the USA and Puerto Rico
Affected count
4080 bottles
Manufactured in
2400 US Highway 130, N/A, Dayton, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0736-2022

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