H.J. Harkins Company, Inc. Products: Prescription Medications Section, Page 36

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VENTOLIN HFA (Albuterol Sulfate)

VENTOLIN HFA is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1). Prevention of exercise-induced bronchospasm in patients 4…

H.J. Harkins Company, Inc.20 January 2012

VIRACEPT (Nelfinavir Mesylate)

VIRACEPT in combination with other antiretroviral agents is indicated for the treatment of HIV infection. Description of Studies. In the clinical studies described below, efficacy was evaluated by the percent of patients with plasma HIV RNA < 400…

H.J. Harkins Company, Inc.18 April 2012

ZALEPLON

Zaleplon is indicated for the short-term treatment of insomnia. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY.). It has not been shown to…

H.J. Harkins Company, Inc.31 August 2011

ZOLPIDEM TARTRATE

Zolpidem tartrate tablets USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets USP have been shown to decrease sleep latency for up to 35 days in controlled…

H.J Harkins Company Inc.6 November 2017

Zyprexa (Olanzapine)

ZYPREXA (olanzapine) is an atypical antipsychotic indicated: As oral formulation for the: Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one…

H.J. Harkins Company, Inc.25 October 2011

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FDA Medwatch

KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a Precautionary Measure Due to a Single Foreign Tablet Found During the Line Clearance After the Batch was Packaged
Mon, 02 Oct 2023. Newtown, Pennsylvania, KVK-Tech, Inc. is voluntarily recalling one lot (Batch Number: 17853A; “the batch”) of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed “K” above bisect “13” on one side and plain…
Biomic Sciences Issues Voluntary Nationwide Recall of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray Products Due to Microbial Contamination
Sun, 01 Oct 2023. Charlottesville, VA – Biomic Sciences is voluntarily recalling all lots of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray products to the consumer level. FDA testing found the product to contain microbial contamination identified as…

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