Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Glenmark Pharmaceuticals Inc., USA

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0452-2025

Other Anhydrous recalls

See all

Class III · Low risk Terminated Oct 20, 2023

Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured…

Reason Subpotent Drug

Edenbridge Pharmaceuticals, LLC NDC 42799-217-01 D-0080-2024

Class II · Moderate risk Terminated Mar 15, 2021

Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-380-01 Manufactured by: Glenmark…

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 68462-380-01 D-0485-2021

Class II · Moderate risk Terminated Mar 6, 2020

Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories…

Reason CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with…

Nostrum Laboratories Inc NDC 29033-001-01 D-1059-2020

Class II · Moderate risk Terminated May 22, 2017

Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLine…

Reason Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The…

Global Marketing Enterprises, Inc. D-1096-2017

Class II · Moderate risk Terminated Mar 30, 2017

Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium…

Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.

Bayer HealthCare Pharmaceuticals, Inc. D-1051-2017