Novel Laboratories, Inc. Products: Prescription Medications Section, Page 7

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Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate

PEG-3350. SODIUM CHLORIDE. POTASSIUM CHLORIDE. SODIUM BICARBONATE for Oral Solution is indicated for bowel cleansing prior to colonoscopy. CONTRAINDICATIONS: PEG-3350. SODIUM CHLORIDE. POTASSIUM CHLORIDE. SODIUM BICARBONATE is contraindicated in…

Novel Laboratories, Inc.28 May 2009

Potassium Chloride

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS. THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT…

Novel Laboratories, Inc.20 December 2019

SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE

Sodium Sulfate. Potassium Sulfate and Magnesium Sulfate Oral Solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults (1) Sodium…

Novel Laboratories, Inc.4 December 2017

Temazepam

Temazepam Capsules USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules USP should be used for short…

Novel Laboratories, Inc.9 August 2012

Tinidazole

Tinidazole Tablets is a nitroimidazole antimicrobial indicated for: Trichomoniasis (1.1) Giardiasis: in patients age 3 and older (1.2) Amebiasis: in patients age 3 and older (1.3) Bacterial Vaginosis: in non- pregnant, adult women (1.4, 8.1) 1.1…

Novel Laboratories, Inc.25 May 2012

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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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