Camerican International of Paramus, NJ is recalling 7.05 oz boxes of Aldi Brand Casa Mamita Churro Bites Filled with Chocolate Hazelnut Cream because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic react
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Field Safety Notices: 19 to 23 May 2025
List of Field Safety Notices from 19 to 23 May 2025.
Infusion Pump Correction: Baxter Updates Instructions for Use for Novum IQ Large Volume Pump due to Potential for Underinfusion
Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for Underinfusion
Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity
Listen to FDA Drug Safety Podcast, FDA’s preliminary evaluation has not found evidence that use of GLP-1 RAs causes suicidal thoughts/actions.
Newly Added Guidance Documents
Guidance documents represent the FDA’s current thinking on a particular subject. New guidance documents are listed here for three months.
Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs
This guidance provides recommendations for how requestors can comply with the requirements described in the Proposed Administrative Order titled Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs.