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July 6, 2022

Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100), Due to the Potential of Missing Labels on Some Pens

Summary Company Announcement Date: July 05, 2022 FDA Publish Date: July 06, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential for the label […]
July 5, 2022

LIV Health LLC dba INFINIWELL and DEAL Media L.L.C. dba HARMONIA – 613114 – 11/23/2021

Delivery Method: United Parcel Service Product: Drugs Recipient: Recipient Name Roger Frantz and Jeremy S. Delk LIV Health LLC dba INFINIWELL and DEAL Media L.L.C. dba […]
July 5, 2022

Identifying Trading Partners Under the Drug Supply Chain Security Act

Submit Comments by 09/05/2022 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 […]
July 5, 2022

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry

Docket Number: FDA-2014-D-1981 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Comments and suggestions regarding this draft document should be submitted within 60 […]
July 5, 2022

MONQ, LLC – 613570 – 06/30/2022

Delivery Method: Via Email Product: Drugs Recipient: MONQ, LLC 842 Conference Dr Suite #2Goodlettsville, TN 37072United States [email protected] Your response should be sent to U.S. Food […]
July 5, 2022

Omni Consumer Products LLC d/b/a YoKratom – 634184 – 06/30/2022

Delivery Method: Via Email Product: Drugs Recipient: Omni Consumer Products LLC d/b/a YoKratom 1650 Pennystone TrlMyrtle Beach, SC 29575United States [email protected] WARNING LETTER June 30, 2022 […]
July 5, 2022

Kratom Exchange – 633972 – 06/30/2022

Delivery Method: Via Email Product: Drugs  WARNING LETTER June 30, 2022 RE: 633972 Dear Kratom Exchange: This letter is to advise you that the U.S. Food […]
July 5, 2022

Klarity Kratom – 634501 – 06/30/2022

Delivery Method: Via Email Product: Drugs WARNING LETTER June 30, 2022 RE: 634501 Dear Klarity Kratom: This letter is to advise you that the U.S. Food […]
July 5, 2022

Herbsens Botanicals – 634373 – 06/30/2022

Delivery Method: Via Email Product: Drugs WARNING LETTER June 30, 2022 RE: 634373 Dear Herbsens Botanicals: This letter is to advise you that the U.S. Food […]
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