FDA Alerts Archive for 2014
January 1, 2014
January 6, 2014
January 8, 2014
January 10, 2014
January 14, 2014
- Pro ArthMax by Human Science Foundation: Recall - Undeclared Drug Ingredients
- t:slim Insulin Cartridges by Tandem Diabetes Care: Recall - Potential for Cartridge Leak
- Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing
- Pro ArthMax by Human Science Foundation: Recall - Undeclared Drug Ingredients
January 17, 2014
January 19, 2014
January 22, 2014
- Dream Body Slimming Capsule: Public Notification - Undeclared Drug Ingredient
- Magic Slim: Public Notification - Undeclared Drug Ingredient
January 31, 2014
- Testosterone Products: Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events
- Mega Slim Herbal Appetite Management Pills by YoungYou International: Recall - Presence of DMAA
February 7, 2014
February 11, 2014
February 14, 2014
- Reduce Weight Fruta Planta: Recall - Undeclared Drug Ingredient
- L-citrulline by Medisca: Alert - Potentially Subpotent Product
February 15, 2014
- Acetylcysteine Solution 10 Percent: Recall - Glass Particles in Product
- L-citrulline by Medisca: Alert - Potentially Subpotent Product
- Acetylcysteine Solution 10 Percent/Roxane: Recall - Glass Particles in Product
February 17, 2014
February 20, 2014
March 6, 2014
- Doribax (doripenem): Drug Safety Communication - Risk When Used to Treat Pneumonia on Ventilated Patients
- DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5 Percent Dextrose 6000mL: Recall - Contamination With Mold
March 7, 2014
March 14, 2014
- VPRIV (velaglucerase alfa for injection): Recall - Visible Particulate Matter
- Reumofan Plus: Recall - Undeclared Drug Ingredient
- Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, USP, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine
March 16, 2014
March 19, 2014
March 20, 2014
March 26, 2014
- Bella Vi Brand Products by Pure Edge Nutrition: Recall - Undeclared Drug Ingredients
- New Life Nutritional Center Dietary Supplements: Recall - Undeclared Drug Ingredients
March 28, 2014
March 31, 2014
- Revatio (sildenafil): Drug Safety Communication - FDA Clarifies Warning About Pediatric Use for Pulmonary Arterial Hypertension
- Nova Products, Inc. Dietary Supplements: Recall - Undeclared Drug Ingredients
April 8, 2014
April 11, 2014
- Infinity: Public Notification - Undeclared Drug Ingredient
- Lite Fit USA: Public Notification - Undeclared Drug Ingredient
April 14, 2014
April 17, 2014
April 18, 2014
- Thinogenics Products by Nature’s Universe: Recall - Undeclared Drug Ingredient
- Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates
- S.W.A.G: Public Notification - Undeclared Drug Ingredient
- Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates
- Cubicin (daptomycin for injection) by Cubist Pharmaceuticals: Recall - Presence of Particulate Matter
April 22, 2014
April 23, 2014
April 24, 2014
April 29, 2014
April 30, 2014
May 6, 2014
- African Black Ant, Black Ant, and Mojo Risen by Eugene Oregon, Inc: Recall - Undeclared Drug Ingredient
- Slim Trim U: Public Notification - Undeclared Drug Ingredient
- Natural Body Solution: Public Notification - Undeclared Drug Ingredient
May 12, 2014
- Asset Bee Pollen: Public Notification - Undeclared Drug Ingredient
- Datascope Corp/MAQUET, Certain Intra-Aortic Balloon Pumps: Recall - Potential Mechanical Failure of Power Supply Fan Assembly
May 13, 2014
May 15, 2014
- Eszopiclone Containing Sleep Aids: Drug Safety Communication - Can Cause Next-Day Impairment
- Dobutamine Injection (250mg/20mL)/Hospira: Recall - Visible Particulates
May 16, 2014
- MV5 Days: Public Notification - Undeclared Drug Ingredient
- Asset Bold: Public Notification - Undeclared Drug Ingredient
- Labetalol Hydrochloride Injection 100 MG/20 ML (5MG/ML), 20 ML, Multidose Vial by Hospira: Recall - Visible Particulates
May 22, 2014
May 28, 2014
May 29, 2014
June 2, 2014
- Soliris (eculizumab) Concentrated Solution for IV Infusion by Alexion: Recall - Visible Particulates
June 3, 2014
June 6, 2014
June 11, 2014
- Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error
- La Jiao Shou Shen: Public Notification - Undeclared Drug Ingredient
June 13, 2014
June 18, 2014
June 19, 2014
- Weight Loss Products: Immediate Public Notification: Undeclared Drug Ingredients
- Male Sexual Enhancement Products: Immediate Public Notification: Undeclared Drug Ingredients
June 20, 2014
- Docetaxel: Drug Safety Communication - May Cause Symptoms of Alcohol Intoxication
- Testosterone Products: FDA/CDER Statement - Risk of Venous Blood Clots
June 24, 2014
- Olmesartan: Drug Safety Communication - FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive
- Red Yeast Rice by Doctor’s Best: Recall - Undeclared Lovastatin
June 25, 2014
June 26, 2014
June 30, 2014
July 1, 2014
July 9, 2014
July 11, 2014
- Sterile Drug Products by Unique Pharmaceuticals Ltd.: Recall - Lack of Sterility Assurance
- Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination
- Sterile Drug Products by Unique Pharmaceuticals Ltd.: Alerting Health Care Professionals - Lack of Sterility Assurance
July 18, 2014
July 19, 2014
July 21, 2014
July 22, 2014
- Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error
July 30, 2014
August 5, 2014
August 7, 2014
- RegeneSlim Appetite Control Capsules: Recall - Presence Of DMAA
- Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter
August 8, 2014
August 9, 2014
August 11, 2014
- Arize: Public Notification - Undeclared Drug Ingredient
- Herbal Vigor Quick Fix: Public Notification - Undeclared Drug Ingredient
August 12, 2014
August 15, 2014
September 2, 2014
- Martin Avenue Pharmacy, Inc. Compounded Sterile Preparations: Recall - Lack of Assurance of Sterility
- Dermatend Original and Dermatend Ultra: Recall - Safety Concerns
- RegeneSlim Appetite Control Capsules: Recall - Presence Of DMAA
September 5, 2014
September 6, 2014
September 9, 2014
September 12, 2014
September 17, 2014
September 26, 2014
- Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events
- Bo Ying Compound by Eu Yan Sang (Hong Kong) Ltd: FDA/CDER Statement - Risk of Lead Poisoning
October 6, 2014
October 8, 2014
- Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall - Uncontrolled Storage During Transit
- SAM Junctional Tourniquet Accessory (Axilla) Strap - SAM Medical Products: Recall - Potential Clip Failure
October 10, 2014
- Sit and Slim II: Public Notification - Hidden Drug Ingredients
- Oregon Compounding Centers, Inc. Unexpired Sterile Products: Recall - Lack of Sterility Assurance
October 15, 2014
October 17, 2014
October 20, 2014
October 22, 2014
October 31, 2014
- 10 Percent Neutral Buffered Formalin by Richard-Allan Scientific: Class I Recall - May Contain Incorrect Concentration of Formalin
- Ginseng Kianpi Pil: Public Notification - Undeclared Drug Ingredients
November 5, 2014
November 14, 2014
November 16, 2014
November 17, 2014
November 18, 2014
November 20, 2014
- Forever Beautiful Bee Pollen by REFA Enterprises: Recall - Undeclared Drug Ingredients
- Intravia Containers by Baxter: Recall - Particulate Matter
November 21, 2014
November 24, 2014
- Super Extreme Accelerator: Public Notification - Undeclared Drug Ingredient
- Black Storm: Public Notification - Undeclared Drug Ingredient
- Bee Thin: Public Notification - Undeclared Drug Ingredient
- Bee Slim: Public Notification - Undeclared Drug Ingredient
- Gabapentin Capsules, USP 300 mg, by Aurobindo Pharma USA: Recall - Complaints of Empty Capsules
November 25, 2014
November 26, 2014
December 9, 2014
December 11, 2014
December 16, 2014
December 21, 2014
- B-Lipo Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredient
- SLIM-K Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredients
December 23, 2014
December 30, 2014
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