Drug Enforcement D-0452-2025

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

Status

Ongoing

Classification

Class II

Report Date

June 4, 2025

Termination Date

—

Product Information

Product description
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
Product quantity
8,520 100-count bottles
Reason for recall
OOS results reported for the Dissolution (by UV) test.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Address
750 Corporate Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0452-2025
Event ID
96867
Recall initiation date
May 15, 2025
Center classification date
May 28, 2025
Code info
Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26
More code info
—