FDA recall D-1171-2022

Glenmark Pharmaceuticals Inc., USA · Class II · drug

Product

Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01

Reason for recall

CGMP Deviations

Distribution

One sole distributor in TX

Key facts

Status: Terminated
Initiation date: 2022-06-29
Report date: 2022-07-06
Termination date: 2023-06-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1171-2022