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Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution and Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution Due to Pr

Canton, SD, Jarman’s Midwest Cleaning Systems, Inc. is voluntarily recalling all lots of Alcohol Antiseptic 80% Topical So...

Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program

The Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program is designed to expand DDT types by e...

Drug Compounding and Drug Shortages

Drug Compounding and Drug Shortages

FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma

On March 22, 2023, the Food and Drug Administration granted accelerated approval to retifanlimab-dlwr (Zynyz, Incyte Corpo...

Electronic Systems, Electronic Records, and Electronic Signatures Webinar - 04/25/2023

In this webinar, FDA will present the current thinking regarding 21 CFR 11 and its application to electronic records, elec...

Ascend Laboratories LLC. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Parsippany. New Jersey. Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules. USP 75 mg and 150...

Herbal Vitality, Inc. - 640206 - 03/07/2023

Unapproved New Drugs/Misbranded

Dunagin Pharmaceuticals Inc. dba Massco Dental - 644335 - 02/22/2023

CGMP/Finished Pharmaceuticals/Adulterated

Procter & Gamble Manufactura S. de R.L. de C.V. - 650837 - 03/14/2023

Failure to Register and List

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