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June 29, 2020

UVT, INC. Issues Voluntary Nationwide Recall of SANIDERM ADVANCED HAND SANITIZER Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)

Summary Company Announcement Date: June 29, 2020 FDA Publish Date: June 29, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of methanol […]
June 29, 2020

FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer

On June 29, 2020, the Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf(PHESGO, Genentech, Inc.) for subcutaneous injection for the […]
June 29, 2020

Surmasis Pharmaceutical – 553686 – 06/22/2020

Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Mr. Lorne C. Scharnberg Recipient Title CEO Surmasis Pharmaceutical 4020 Gannett AvenueDes Moines, IA 50321United States […]
June 29, 2020

Surmasis Pharmaceutical – 553686 – 11/06/2018

November 6, 2018 WARNING LETTER Case# 553686   UPS NEXT DAY SIGNATURE REQUIRED Mr. Lorne C. Scharnberg CEO Surmasis Pharmaceutical 4020 Gannett Avenue Des Moines, Iowa […]
June 29, 2020

SuperHealthGuard and Loyal Great International Ltd. – 608633 – 06/26/2020

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States This is to advise you that the United […]
June 29, 2020

Nuance Health, LLC – 608405 – 06/26/2020

Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER Date:   June 26, 2020 TO:  [email protected] –Kent New and Jennifer Sawyer […]
June 29, 2020

Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry

Docket Number: FDA-2014-D-1747 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research [Updated June 29, 2020] This guidance […]
June 29, 2020

Development of Anti-Infective Drug Products for the Pediatric Population

Submit Comments by 09/29/2020 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 […]
June 27, 2020

Saniderm Products Voluntarily Issues Regional (Virginia, Maryland, New Jersey) Recall of 1 L Saniderm Advanced Hand Sanitizer bottles produced by Eskbiochem SA de CV Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)

Summary Company Announcement Date: June 26, 2020 FDA Publish Date: June 27, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description May contain methanol (wood […]
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