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May 26, 2020

Samchundang Pharm Co., Ltd. – 599255 – 05/13/2020

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. In-Seok Chun Recipient Title CEO Samchundang Pharm Co., Ltd. 351, Hyoryeong-roSeocho-guSeoul06643South Korea Issuing Office: Center for […]
May 26, 2020

Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents

Submit Comments by 07/27/2020 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
May 26, 2020

ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents

The International Council  on Harmonisation (ICH) has developed maintenance procedures  (PDF – 26KB) for revising the permitted daily exposure (PDE) of solvents included in the Q3C […]
May 26, 2020

FDA approves brigatinib for ALK-positive metastatic NSCLC

On May 22, 2020, the Food and Drug Administration approved brigatinib (ALUNBRIG, ARIAD Pharmaceuticals Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell […]
May 22, 2020

Apace Packaging LLC Issues Voluntary Nationwide Recall of Cyclobenzaprine HCL and Amantadine HCL (Lot 16710) Due to Potential Mislabeling

Summary Company Announcement Date: July 26, 2017 FDA Publish Date: February 07, 2018 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Cyclobenzaprine HCL may […]
May 22, 2020

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency

Summary Company Announcement Date: May 22, 2020 FDA Publish Date: May 22, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Super potency Company Name: […]
May 22, 2020

Coronavirus (COVID-19) Update: Daily Roundup May 22, 2020

For Immediate Release: May 22, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
May 22, 2020

Isomeric Pharmacy Solutions Issues Voluntary Nationwide Recall of All Sterile Compounded Products

Summary Company Announcement Date: April 06, 2017 FDA Publish Date: February 07, 2018 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Lack of […]
May 22, 2020

Dougherty’s Pharmacy – 500635 – 05/14/2020

Delivery Method: VIA Electronic Mail Reference #: 2017-DAL-WL-22 Product: Drugs Recipient: Recipient Name Stewart I. Edington Recipient Title President/CEO Dougherty’s Pharmacy 5924 Royal LaneSuite 250Dallas, TX […]
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