Safety Alerts and Recalls – MPR
Mylan Recalls One Lot of Daptomycin for Injection
Wed, 08 Jul 2020 18:40:00 +0000

According to Mylan, the administration of the recalled product may lead to “serious adverse events including, but not limited to, local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism.”

The post Mylan Recalls One Lot of Daptomycin for Injection appeared first on MPR.

FDA: Risk of Methanol Toxicity With Certain Hand Sanitizers
Mon, 06 Jul 2020 17:00:16 +0000

Hand sanitizers containing methanol, or wood alcohol, present a danger to individuals as the substance can be toxic when absorbed through the skin or life-threatening if ingested.

The post FDA: Risk of Methanol Toxicity With Certain Hand Sanitizers appeared first on MPR.

Supplements With Undeclared Active Ingredients Pose Substantial Health Risk
Thu, 25 Jun 2020 15:51:16 +0000

A recent Morbidity and Mortality Weekly Report (MMWR) highlights the risks associated with use of over-the-counter (OTC) products containing undeclared prescription ingredients as well as the importance of collaboration between various health departments and systems to ensure a prompt response to an outbreak.

The post Supplements With Undeclared Active Ingredients Pose Substantial Health Risk appeared first on MPR.

OTC Cough/Cold Meds Recalled Due to Incorrect Dosing Cups
Tue, 23 Jun 2020 16:00:00 +0000

GlaxoSmithKline (GSK) Consumer Healthcare announced the voluntary recall of 2 lots of Children’s Robitussin® Honey Cough and Chest Congestion DM and 1 lot of Children's Dimetapp® Cold and Cough due to the inclusion of incorrect dosing cups.

The post OTC Cough/Cold Meds Recalled Due to Incorrect Dosing Cups appeared first on MPR.

FDA Revokes EUA for COVID-19 Antibody Test, Cracks Down on Fraudulent At-Home Tests
Thu, 18 Jun 2020 19:18:08 +0000

Warning letters have been issued to 3 companies marketing adulterated and misbranded serological tests that claim to detect antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), according to the FDA.

The post FDA Revokes EUA for COVID-19 Antibody Test, Cracks Down on Fraudulent At-Home Tests appeared first on MPR.

Warning Letters Issued to Several Companies Selling Unapproved “Homeopathic” Injectables
Thu, 18 Jun 2020 17:40:56 +0000

The FDA has issued warning letters to several companies selling unapproved injectable products labeled as homeopathic.

The post Warning Letters Issued to Several Companies Selling Unapproved “Homeopathic” Injectables appeared first on MPR.

FDA: Vial Caps of Two Neuromuscular Blocking Agents May Not Have Warning Statement
Thu, 04 Jun 2020 16:15:00 +0000

The FDA is notifying healthcare professionals regarding the temporary absence of the "paralyzing agent" warning statement on vial caps of vecuronium bromide for injection

The post FDA: Vial Caps of Two Neuromuscular Blocking Agents May Not Have Warning Statement appeared first on MPR.

FDA: Certain Epinephrine Autoinjector Devices May Have Missing Safety Component
Tue, 02 Jun 2020 19:38:54 +0000

Certain lots of Amneal’s Epinephrine Injection, Autoinjector 0.3mg may not contain the yellow "stop collar" that is necessary for proper dosing of the anaphylaxis treatment, according to the FDA.

The post FDA: Certain Epinephrine Autoinjector Devices May Have Missing Safety Component appeared first on MPR.

FDA: Unacceptable NDMA Levels Identified in Certain Metformin ER Products
Fri, 29 May 2020 15:00:00 +0000

Specifically, unacceptable levels of this potentially carcinogenic impurity have been identified in products manufactured by 5 different firms.

The post FDA: Unacceptable NDMA Levels Identified in Certain Metformin ER Products appeared first on MPR.

Superpotent Lots of Hypothyroidism Treatment NP Thyroid Recalled
Wed, 27 May 2020 14:00:00 +0000

Testing revealed that the product may have up to 115% of the labeled amount of Liothyronine (T3) (acceptable range is 90.0-110.0%).

The post Superpotent Lots of Hypothyroidism Treatment NP Thyroid Recalled appeared first on MPR.

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