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    FDA MedWatch Alerts

    MPM Medical LLC Issues Voluntary Nationwide Recall of Regenecare HA Hydrogel Due to Burkholderia cepecia Contamination

    December 2, 2020 -- Mesquite, TX MPM Medical is voluntarily recalling one lot of Regenecare HA Hydrogel to the consumer level. Following two customer...

    Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine

    November 19, 2020 -- Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg...

    Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

    November 09, 2020 -- Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an...

    Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

    November 03, 2020 -- Nostrum Laboratories, Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that...

    Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

    November 02, 2020 -- Kansas City, Missouri, Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 750...

    Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex? Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

    Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from...

    Drug Safety Communication: Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) - Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later

    ISSUE: FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to...

    Marksans Pharma Limited Issues Expansion of Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)

    October 05, 2020 -- Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired...

    Drug Safety Communication: Benadryl (diphenhydramine) - Serious Problems with High Doses of the Allergy Medicine

    ISSUE: FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to...

    Drug Safety Communication: Benzodiazepine Drug Class - Boxed Warning Updated to Improve Safe Use

    ISSUE: The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for...

    Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Riomet ER? (Metformin Hydrochloride for Extended-Release Oral Suspension) Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

    September 23, 2020 -- Sun Pharmaceutical Industries, Inc. (Sun Pharma), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily...

    FDA Alerts of Perrigo's Voluntary Albuterol Inhaler Recall

    September 21, 2020 -- The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of all unexpired albuterol...

    Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid? (Thyroid Tablets, USP) Due to Sub Potency

    September 17, 2020 -- Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP...

    FDA Alerts Health Care Professionals and Oncology Clinical Investigators About Efficacy and Potential Safety Concerns with Atezolizumab in Combination with Paclitaxel for Treatment of Breast Cancer

    September 8, 2020 -- FDA is alerting health care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of...

    Corgiomed LLC Issues Voluntary Nationwide Recall of All Lots of Leafree Instant Hand Sanitizer Aloe Vera Labeled as EDIBLE ALCOHOL

    List of Recalled Alcohol-Based Hand Sanitizer Products (FDA) FDA advises consumers not to use hand sanitizers on this list. September 3, 2020 --...

    RLC Labs, Inc., Issues Voluntary Nationwide Recall of All Lots of Nature-Throid? and WP Thyroid? with Current Expiry Due to Sub Potency

    September 3, 2020 -- RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in all strengths, all counts of...

    The Protein Shoppe, LLC Issues Voluntary Nationwide Recall of the “Red- E” Male Enhancement Tablet Due to the Presence of Undeclared Sildenafil

    September 1, 2020 -- The Protein Shoppe, LLC is voluntarily recalling all lots of “Red-E” (Male Enhancement tablet) to the consumer level. This...

    Mylan Initiates Voluntary Nationwide Recall of Four Lots of Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP Due to Carton Label Mix-Up

    August 28, 2020 -- Mylan N.V. today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the...

    COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers

    Silver Spring, MD -- August 27, 2020 -- The U.S. Food and Drug Administration (FDA) is warning consumers about alcohol-based hand sanitizers that are being...

    Bayshore Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

    August 20, 2020 -- Bayshore Pharmaceuticals, LLC, Short Hills, NJ is voluntarily recalling one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP,...

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