Medications Updated During July 2017, From Newest to Oldest, Page 2

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Panhematin (Hemin)

PANHEMATIN is a hemin for injection indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women, after initial carbohydrate therapy is known or suspected to be…

RECORDATI RARE DISEASES, INC.31 July 2017

Kayexalate (Sodium Polystyrene Sulfonate)

KAYEXALATE is indicated for the treatment of hyperkalemia. Limitation of Use: KAYEXALATE should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [ see Clinical Pharmacology (12.2) ]…

Concordia Pharmaceuticals Inc.31 July 2017

Acyclovir

Acyclovir ointment USP 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients. CONTRAINDICATIONS: Acyclovir ointment 5% is…

Glenmark Pharmaceuticals Inc., USA31 July 2017

Hydrocodone Bitartrate and Acetaminophen

Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain. CONTRAINDICATIONS: Hydrocodone bitartrate and acetaminophen tablets should not be administered to patients who have previously…

Mayne Pharma Inc.31 July 2017

Quinapril Hydrochloride

Quinapril hydrochloride is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have…

PD-Rx Pharmaceuticals, Inc.31 July 2017

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FDA Medwatch

CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets
Tue, 07 Jul 2020. As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing. This testing revealed that some…
Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
Tue, 07 Jul 2020. Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA,…

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