FDA recall D-0485-2021

Product

Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-380-01 Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Reason for recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Distribution

FL, GA, SC

Key facts

Status

Terminated

Initiation date

2021-03-15

Report date

2021-06-02

Termination date

2024-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0485-2021