Food & drugs

Sundial Herbal Products is Recalling Products Attached Because these Products were Misbranded. The Products are Currently Unapp

09-07-2020

To be in compliance with FDA Drug Regulations, Sundial is requesting an immediate recall, removal and return, of all Sundial Products, distributed from the period beginning January 1, 2014 through current, that have labeling containing/making drug...

Maquiladora Miniara S.A. de C.V. Issues Voluntary Nationwide Recall of Shine and Clean Hand Sanitizer and Due to Potential Pres

09-07-2020

Maquiladora Miniara S.A. de C.V. is voluntarily recalling lots of Shine and Clean Hand Sanitizer gel to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol) Substantial methanol exposure can...

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and

08-07-2020

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,...

CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets

08-07-2020

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...

Endologix Issues Correction Notice for Ovation iX Abdominal Stent Graft System

08-07-2020

Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the...

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and

08-07-2020

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,...

Allergy Alert: KIND Issues Voluntary Recall Due to Undeclared Sesame Seeds in Oats & Honey

07-07-2020

KIND Healthy Snacks (KIND) is voluntarily recalling a limited number of Oats & Honey Granola with Toasted Coconut pouches due to the presence of sesame seeds, which is not listed as an ingredient in the product. The label does list “sesame...

Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate

07-07-2020

Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate...

Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 750

06-07-2020

Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of...

ITECH 361 Issues Voluntary Nationwide Recall of All Clean Hand Sanitizer and Moisturizer and Disinfectant Due to The Potential

06-07-2020

ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand Sanitizer, Moisturizer and Disinfectant sold in one liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

UPDATE: Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers

06-07-2020

The FDA is providing the most recent, interim post-approval study results for Abiomed's Impella RP System.

False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System - Letter to Clinical Laboratory Staff and Health Care

06-07-2020

FDA warns lab staff that use of BD SARS-CoV-2 Reagents for the BD Max System may lead to false positive results.

Sundial Herbal Products is Recalling Products Attached Because these Products were Misbranded. The Products are Currently Unapp

Maquiladora Miniara S.A. de C.V. Issues Voluntary Nationwide Recall of Shine and Clean Hand Sanitizer and Due to Potential Pres

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and

CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets

Endologix Issues Correction Notice for Ovation iX Abdominal Stent Graft System

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and

Allergy Alert: KIND Issues Voluntary Recall Due to Undeclared Sesame Seeds in Oats & Honey

Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate

Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 750

ITECH 361 Issues Voluntary Nationwide Recall of All Clean Hand Sanitizer and Moisturizer and Disinfectant Due to The Potential

UPDATE: Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers

False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System - Letter to Clinical Laboratory Staff and Health Care

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UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication

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