FDA Alerts
2024
MC24-003-CG Medicines for Type 2 Diabetes-Obesity - FDA Evaluation Reports of Suicidal Thoughts or Action MC24-005-CG Prolia (denosumab) FDA Adds Boxed Warning for Increase Risk of Hypocalcemia MC24-006-CG Azurity recall 1 lot Zenzedi (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled MC24-010-CG Brassica recall Lubricant Eye Ointment Equate, Equate Stye, CVS, Lubricant PM due to Sterility MC24-012-CG MC-Rx Info Series Vol 62 March 2024 Tips for Pharmacies Compounding Practices Focus Semaglutide MC24-013-CG Par Pharmaceutical recall 1 lot Treprostinil Injection 20mg 20mL (1mg mL) MC24-016-CG Eugia recall 1 lot Methocarbamol Injection USP 1000 mg 10 mL 100mg mL Single Dose MC24-017-CG AvKARE recall 1 lot Atovaquone Oral Suspension USP 750 mg 5 mL Due to Contamination MC24-021-CG Dr. Reddys recall 6 lots Sapropterin Dihydrochloride Powder for Oral Solution 100 mg MC24-025-CG FDA warns consumers not use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain MC24-028-CG FDA Glenmark recall 114 batches Potassium Chloride ER Caps USP 750 mg 10 mEq K MC24-029-CG FDA American Health-BluePoint recall 21 batches Potassium Chloride ER Caps USP 750 mg MC24-035-CG FDA - Endo recall 1 lot Clonazepam ODT due to mislabeling incorrect Strength MC24-041-CG FDA Bionpharma recall 1 batch Atovaquone Oral Suspension 750mg due to Contamination MC24-042-CG FDA warning Veozah used for hot flashes due to menopause can cause serious liver injury
2023
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MC23-004-CG FDA Spectrum recall 3 lots of Epinephrine (L-Adrenaline) USP due to product discolored
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MC23-011-CG FDA IBSA recall 27 lots TIROSINT-SOL (levothyroxine sodium) Oral Solution due to subpotency
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MC23-012-CG FDA Global recall all lots Artificial Tears Lubricant Eye Drops
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MC23-015-CG FDA Apotex Recall 6 lots Brimonidine Tartrate Ophthalmic Solution, 0.15
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MC23-018-CG FDA Ascend recall Dabigatran Etexilate Caps USP 75 mg and 150 mg due to nitrosamine
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MC23-023-CG FDA Camber recall 1 lot Atovaquone Oral Suspension USP 750mg 5mL due to Bacillus cereus
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MC23-024-CG FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena
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MC23-025-CG FDA Update Prescribing Info to Provide Guidance for Safe Use All Opioid Pain Medicine
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MC23-026-CG FDA Teva recall Specific Lots of FENTANYL Buccal Tablets CII Due to a Labeling Error
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MC23-028-CG FDA Akorn recall various within-expiry human and animal products due to company shutdown
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MC23-031-CG FDA Update Warnings to Improve Safe Use of Prescription Stimulants Used to Treat ADHD
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MC23-033-CG FDA Harvard Drug recall 1 lot Dronabinol Caps USP 2.5mg and Ziprasidone HCL Caps 20mg
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MC23-038-CG FDA Cipla recall 6 batches Albuterol Sulfate Inhalation Aerosol, 90 mcg
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MC23-043-CG FDA Lupin recall 2 lots Tydemy Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tabs
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MC23-047-CG FDA Marlex recall Digoxin Tabs USP, 0.125mg and 0.25mg Due to Label Mix-Up
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MC23-049-CG FDA Novartis recall 1 Lot Sandimmune Oral Sol (Cyclosporine) 100 mgmL due crystallization
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MC23-051-CG FDA change therapeutic equivalence rating for Accord generics Prograf oral caps
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MC23-052-CG FDA VistaPharm recall 1 lot Sucralfate Oral Suspension 1g10mL due to Bacillus
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MC23-054-CG FDA SCYNEXIS recall 2 lots BREXAFEMME (ibrexafungerp tablets) due to cross contamination
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MC23-059-CG FDA KVK-Tech recall 1 lot Betaxolol Tablets USP 10mg due to foreign tablet found on packaging
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MC23-062-CG FDA Bayer Issues Voluntary Recall Nationwide of VITRAKVI® (larotrectinib) Oral Solution 20 mgmL Due to Presence of Microbial Contamination
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MC23-064-CG FDA Novartis issues recall of Sandimmune Solution 100 mgmL due to crystal formation
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MC23-065-CG FDA Drug Safety Communication - FDA Warns of Rare but Serious Drug Reaction
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MC23-067-CG FDA InvaGen Recall 1 lot Vigabatrin for Oral Solution USP 500mg due to Leaking Sachets
2022
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MC22-003-CG FDA - Taro recall 1 lot Clobetasol Propionate Ointment USP, 0.05% 60 g tubes
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MC22-007-CG FDA warning dental problems with buprenorphine medicine dissolved in the mouth
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MC22-009-CG FDA Viona recall 23 lots Metformin HCI ER USP 750 mg
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MC22-013-CG-FDA Mylan Pharmaceuticals Recall of One Batch of Semglee 100 unitsmL (U-100), 3 mL Pens,
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MC22-026-CG FDA investigating possible increased of death with cancer medicine Ukoniq (umbralisib)
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MC22-036-CG FDA - Sandoz recall of 13 lots Orphenadrine Citrate 100 mg Extended Release (ER) Tablets
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MC22-037-CG FDA - Adamis Pharm recall certain lots SYMJEPI Injection 0.15 mg (0.15 mg0.3 mL) and 0.3
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MC22-038-CG FDA - Pfizer recall 6 lots Accuretic -1 quinapril & hydrochlorothiazide 4 quinapril HCl hydroch
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MC22-045-CG FDA - Mylan recall 1 batch Insulin Glargine Injection 100 units mL (U-100)
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MC22-047-CG FDA - Pfizer recall 5 lots Accupril (Quinapril HCl) tablets due to nitrosamine
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MC22-055-CG FDA Teva recall 1 lot of Anagrelide Capsules, USP 0.5 mg (Lot number GD01090)
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MC22-056-CG Recall Ukoniq - FDA Approval of Lymphoma Medicine is Withdrawn Due to Safety Concerns
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MC22-062-CG FDA Bryant recall 1 lot Morphine Sulfate 30 mg ER and 1 lot of 60 mg ER due incorrect labeling
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MC22-063-CG FDA Warns About Increased Risk of Death and Side Effects with Copiktra (duvelisib)
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MC22-064-CG FDA Mylan recall 1 Batch Insulin Glargine Injection Pens, 100 units mL due to Missing Labels
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MC22-070-CG FDA - Vi-Jon recall all lots of all flavors of Magnesium Citrate Saline Laxative Oral Solution
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MC22-077-CG FDA – GSMS recall certain lots Clopidogrel 75mg Tabs mislabeled as Atenolol 25mg Tablets
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MC22-084-CG FDA-Mylan Recall 1 Lot Octreotide Acetate Injection 500 mcgMl due Glass Particulates in Syringe
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MC22-085-CG FDA-Aurobindo Recall 2 Lots of Quinapril and Hydrochlorothiazide Tablets
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MC22-086-CG FDA Insulet Medical Device Correction for Omnipod 5 Automated Insulin Delivery System
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MC22-088-CG FDA Investigating Risk of Severe Hypocalcemia in Patients on Dialysis
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MC22-090-CG FDA Detect recalling specific lots of the Detect Covid-19 Test
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MC22-094-CG FDA announced that Lupin recall 4 lots Quinapril Tablets
FDA Drug Updates
2020