THEOPHYLLINE
Generic: THEOPHYLLINE
Zydus Lifesciences LimitedManufacturer
ORALRoute
THEOPHYLLINE ANHYDROUSActive Substance
2024-05-21Original Approval
THEOPHYLLINE is FDA application ANDA218063, sponsored by ZYDUS LIFESCIENCES. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2025-05-15
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark PhOOS results reported for the Dissolution (by UV) test.
Class II2025-08-08
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals LimiteFailed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV)
Class II2021-03-15
Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-380-01 Manufactured by: Glenmark CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Top Reported Reactions
1
DYSPNOEA
2,399 reports
2
ASTHMA
2,072 reports
3
PNEUMONIA
1,444 reports
4
WHEEZING
1,408 reports
5
VOMITING
1,216 reports
6
COUGH
1,106 reports
7
DRUG HYPERSENSITIVITY
940 reports
8
MALAISE
810 reports
9
DRUG INEFFECTIVE
785 reports
10
OEDEMA
770 reports