Recall: D-0485-2021

Class II - Potentially Harmful

Class IIClassification

2021-03-15Initiated

TerminatedStatus

Cardinal Health Inc.Firm

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

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Distribution

FL, GA, SC

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.