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September 29, 2022

FDA approves first treatment for prurigo nodularis

Action FDA has approved Dupixent (dupilumab) injection for the treatment of adults with prurigo nodularis (PN). This is the first FDA-approved treatment for PN. Dupixent is […]
September 29, 2022

Bespoke Apothecary LLC – 641573 – 09/28/2022

Product: Drugs Recipient: Recipient Name April Hart and Bill Krovetcz Bespoke Apothecary LLC 300 Sullivan Crest RoadElmira, NY 14901United States [email protected] WARNING LETTER RE: 641573 Date: […]
September 28, 2022

Proper Trade LLC/My Stellar Lifestyle Issues Voluntary Nationwide Recall of Wonder Pill Capsules Due to the Presence of Undeclared Tadalafil

Summary Company Announcement Date: September 27, 2022 FDA Publish Date: September 28, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains undeclared tadalafil […]
September 27, 2022

Eugia US LLC Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), Due to the Presence of Particulate Matter

Summary Company Announcement Date: September 27, 2022 FDA Publish Date: September 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of a dark […]
September 27, 2022

Zhejiang Tianyu Pharmaceutical Co., Ltd. – 631054 – 08/17/2022

Delivery Method: Return Receipt Requested Product: Drugs Recipient: Recipient Name Mr. Yongjun Tu Recipient Title Chief Executive Officer and Chairman of the Board Zhejiang Tianyu Pharmaceutical […]
September 27, 2022

Muscle Sports Products, LLC – 625731 – 09/23/2022

Delivery Method: United Parcel Service Product: DrugsFood & Beverages Recipient: Recipient Name Jason R. Mancuso Recipient Title CEO Muscle Sports Products, LLC 101 Dominion Blvd.Ronkonkoma, NY […]
September 27, 2022

System Kosmetik Produktionsgesellschaft fur kosmetische Gmbh – 632727 – 09/09/2022

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Ms. Petra Mikschl Recipient Title Chief Executive Officer/Co-owner System Kosmetik Produktionsgesellschaft fur kosmetische Gmbh Raiffeisenstr. 2Munster86692 […]
September 27, 2022

Providing Over-the-Counter Monograph Submissions in Electronic Format

Submit Comments by 11/28/2022 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 […]
September 26, 2022

Walfer Corporation dba Wallace Pharmacy – 611017 – 09/20/2022

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Wayne Wallace Recipient Title Owner Walfer Corporation dba Wallace Pharmacy 3524 B Tamiami TrailPort Charlotte, FL 33952-8100United […]
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