FDA recall D-1071-2020

Product

Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01

Reason for recall

Failed Impurities/Degradation Specification: Presence of unknown impurity observed.

Distribution

Product was distributed within the United States.

Key facts

Status

Terminated

Initiation date

2020-03-30

Report date

2020-04-08

Termination date

2021-11-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chestnut Ridge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1071-2020