Cardinal Health Inc. recalls Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-380-01 Manufactured by: Glenmark
Recalled June 2, 2021 · FDA recall D-0485-2021 · Cardinal Health
Hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage. · FDA Class II
Units
141 bottles
Sold at
FL, GA, SC
Description
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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
Manufacturer(s)
Cardinal Health Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →