FDAFDA · Food and drugs·Recall number D-0485-2021
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
Published June 2, 2021 · Recall initiated: March 15, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- THEOPHYLLINE
- Manufacturer
- Cardinal Health Inc.
- Distributor
- FL, GA, SC
- UPC
- 0368462380017
- Lot
- 19205025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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