by Pill Pals Customer Service | Apr 1, 2025 | News
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Author affiliation: Centers for Disease Control and Prevention, Atlanta,...
by Pill Pals Customer Service | Apr 1, 2025 | News
Summary Company Announcement Date: April 01, 2025 FDA Publish Date: April 01, 2025 Product Type: Food & Beverages Juice Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Botulism Company Name: Walker’s Wine...
by Pill Pals Customer Service | Apr 1, 2025 | News
Extended-release, long-acting (ER/LA) and immediate-release (IR) opioid analgesics, such as hydrocodone, oxycodone, and morphine, are powerful pain-reducing medications that have both benefits as well as serious risks. The FDA has determined that a REMS is necessary...
by Pill Pals Customer Service | Apr 1, 2025 | News
Summary Company Announcement Date: March 30, 2025 FDA Publish Date: March 31, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared allergen – peanut, soy, sesame, and wheat. Company Name: Fresh Creative...
by Pill Pals Customer Service | Mar 31, 2025 | News
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without...
by Pill Pals Customer Service | Mar 31, 2025 | News
Update: March 31, 2025The FDA is providing an update that Vantive (formerly Baxter Kidney Care) has notified its customers that no PCBs were detected in MiniCap Extended Life PD transfer sets, and PCBAs were found at levels not posing a risk for patients over six...
by Pill Pals Customer Service | Mar 31, 2025 | News
What are “Novel” Drugs?”Novel” drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.FDA Novel Drug Therapy Approvals for 2025No.Drug...
by Pill Pals Customer Service | Mar 31, 2025 | News
Alecensa (alectinib) capsulesAlunbrig (brigatinib) tabletsLorbrena (lorlatinib) tabletsZykadia (ceritinib) capsules; tabletsOptic neuropathyFDA is evaluating the need for regulatory action.AntidepressantsSelective serotonin reuptake inhibitors...
by Pill Pals Customer Service | Mar 31, 2025 | News
The Prescription Drug User Fee Act of 1992 (PDUFA), Biosimilar User Fee Act of 2012 (BsUFA), and Generic Drug User Fee Amendments of 2012 (GDUFA) authorize FDA to collect user fees from industry to support activities related to the review of certain human medical...
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