FDA Alerts
2025
MC25-001-CG FDA Astellas recall 1 lot PROGRAF 0.5mg and 1 of ASTAGRAF XL 0.5mg capsules MC25-005-CG FDA - Requires Guillain-Barré Warning in Prescribing Info for RSV Vaccines Abrysvo and Arexvy MC25-006-CG Copaxone, Glatopa FDA Adds Boxed Warning About Serious Allergic Reaction Called Anaphylaxis MC25-007-CG FDA Alvogen recalling 1 lot Fentanyl Transdermal System 25 mcgh transdermal patches MC25-011-CG FDA warns about allergy medicines cetirizine or levocetirizine long-term use may cause itching MC25-012-CG FDA Amneal recall 3 lots of Sulfamethoxazole Trimethoprim Tablets USP 400 mg 80 mg MC25-013-CG FDA Warning About Risk of Heat-Related Complications with Antinausea Patch Transderm Scōp MC25-014-CG FDA Require Expand Label Weight Loss Patients Younger than 6 yrs taking ER Stimulants for ADHD MC25-017-CG FDA - CBER suspended biologics license for Valneva Austria GmbH’s Ixchiq (Chikungunya Vaccine) MC25-018-CG FDA recommend earlier MRI for patients with Alzheimer disease taking Leqembi (lecanemab) MC25-019-CG FDA Removes Risk Evaluation Mitigation Strategies Program for Antipsychotic Drug Clozapine MC25-020-CG FDA Nostrum recall Sucralfate Tablets USP 1 gram all lots within expiry MC25-021-CG FDA Unichem recalling 1 lot Cyclobenzaprine Hydrochloride Tabs USP 10 mg due to Mislabeling MC25-023-CG FDA Nationwide recall atorvastatin calcium tablets 10, 20, 40, 80 milligram doses MC25-024-CG FDA Early Alert Glucose Monitor Sensor - FreeStyle Libre 3 Several Models from Abbott (1) MC25-025-CG Update on the Safety of Andexxa by AstraZeneca FDA Safety Communication
2024
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MC24-003-CG Medicines for Type 2 Diabetes-Obesity - FDA Evaluation Reports of Suicidal Thoughts or Action
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MC24-005-CG Prolia (denosumab) FDA Adds Boxed Warning for Increase Risk of Hypocalcemia
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MC24-006-CG Azurity recall 1 lot Zenzedi (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled
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MC24-010-CG Brassica recall Lubricant Eye Ointment Equate, Equate Stye, CVS, Lubricant PM due to Sterility
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MC24-012-CG MC-Rx Info Series Vol 62 March 2024 Tips for Pharmacies Compounding Practices Focus Semaglutide
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MC24-013-CG Par Pharmaceutical recall 1 lot Treprostinil Injection 20mg 20mL (1mg mL)
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MC24-016-CG Eugia recall 1 lot Methocarbamol Injection USP 1000 mg 10 mL 100mg mL Single Dose
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MC24-017-CG AvKARE recall 1 lot Atovaquone Oral Suspension USP 750 mg 5 mL Due to Contamination
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MC24-021-CG Dr. Reddys recall 6 lots Sapropterin Dihydrochloride Powder for Oral Solution 100 mg
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MC24-025-CG FDA warns consumers not use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain
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MC24-028-CG FDA Glenmark recall 114 batches Potassium Chloride ER Caps USP 750 mg 10 mEq K
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MC24-029-CG FDA American Health-BluePoint recall 21 batches Potassium Chloride ER Caps USP 750 mg
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MC24-035-CG FDA - Endo recall 1 lot Clonazepam ODT due to mislabeling incorrect Strength
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MC24-041-CG FDA Bionpharma recall 1 batch Atovaquone Oral Suspension 750mg due to Contamination
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MC24-042-CG FDA warning Veozah used for hot flashes due to menopause can cause serious liver injury
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MC24-049-CG FDA Endo expands its voluntary recall of Clonazepam Orally Disintegrating Tablets USP
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MC24-050-CG FDA Drug Safety - Ocaliva by Intercept - Serious Liver Injury in Patients without Cirrhosis
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MC24-052-CG FDA Warning Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes
FDA Drug Updates
2020