NDC 68462-356
Theophylline 600 mg tablet, extended release
On the label: Glenmark Pharmaceuticals Inc., USA.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Goa, India | Makes it and tests it | Problems found, fixed voluntarilyJun 30, 2026 · 7 inspections, 1 with FDA action |
Recalls
- Aug 8, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
Lots: Batch # 19243193, 19243215, 19243231,19243248, 19243283, Exp 7/31/2026; 19244530, 19244561, Exp 10/31/2026; 19250178, Exp 12/31/2026 - May 15, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
OOS results reported for the Dissolution (by UV) test.
Lots: Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26 - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: 19205025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Theophylline: every company that makes it
- Form
- tablet, extended release, oral
- Strength
- 600 mg
- Approval
- ANDA ANDA090355
- On the market since
- Jul 13, 2010
- Package NDCs
68462-356-0168462-356-05- Official label
- DailyMed (National Library of Medicine), updated Jan 29, 2026
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