FDA recall D-0452-2025

Glenmark Pharmaceuticals Inc., USA · Class II · drug

Product

Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01

Reason for recall

OOS results reported for the Dissolution (by UV) test.

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2025-05-15
Report date: 2025-06-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0452-2025