Defective drugs are responsible for billions of dollars in medical expenses in the United States annually and an untold amount of needless pain and suffering. Although the United States government has an agency (The FDA) in place to review the safety and effectiveness of drugs before they are released for public use, there are still a lot of ways for a company to get an unsafe or ineffective product on the market. Below is a list of the most recent FDA recalls with links for more information:
Typically a drug will have to go through rigorous testing before the FDA will issue market approval. But the FDA is overworked and the drug manufacturers and distributors have millions of dollars on the line, so the drug companies found a loop hole. Instead of going through the normal process, whereby a drug is tested for months or years prior to market placement, some companies obtain approval from the FDA to market their in the United States through the 510(k) premarket notification process pursuant to 21 U.S.C. § 360(k). Under this loophole, companies assert that their product is substantially equivalent to other products already available on the market. Under this scenario, the actual product is approved for use in the United States by the Food and Drug Administration (FDA), but without the clinical testing that products typically receive. The FDA relies on the representations of the drug manufacturer that the drug is “substantially similar” to a drug the FDA has already tested and approved. The drug manufacturer asks the FDA to certify its product is safe because another device that was “substantially similar” was safe. But “substantial similarity” is in the eye of the beholder, and when it is the company that stands to make billions of dollars making that call, substantial similarity becomes very broad.
Visit our defective drug blog for recent drug recalls. If you or a loved one has been injured by any of the following products, all of which have been recalled, call the Merman Law Firm immediately:
- Sandoz US Announces Precautionary Recall Of Oral Contraceptive Introvale®, Following Report Of Packaging Flaw
- Franck’s Pharmacy: Compounded Prescription Recall
- Hospira Recalls One Lot Of Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject, That May Contain More Than The Intended Fill Volume
- Franck’s Compounding Lab Recalls Triamcinolone acetonide P.F. 80mg/ml
- American Regent Recalls Epinephrine Injection, USP, 1:1000, 1mL Ampules Lot #1395 Due to Discoloration and Small Visible Particles
- XROCK INDUSTRIES, LLC Recalls X-ROCK, a Product Marketed as a Dietary Supplement To Support Male Sexual Performance, Due to Unlisted, Potentially Hazardous Ingredient
- Hospira Recalls One Lot of Morphine Sulfate Injection, USP 4 MG/ML, (C-II) 1 ML Fill in 2.5 ML Carpuject, That May Contain More Than The Intended Fill Volume
- Franck’s Lab Recalls One Lot of triamcinolone acetonide P.F. 80mg/ml
- American Regent Recalls Cyanocobalamin Injection, USP, 100 mcg/mL, 1ml Vial Lot #s 1662, 1679, 1683
- Recall of Brilliant Blue G
- Bedford Laboratories™ Issues Nationwide Voluntary Recall of Cytarabine for Injection, USP, 1 Gram per Vial
- Regeneca, Inc. Issues a Voluntary Nationwide Recall of All Lots of Single Capsule RegenErect Because of Potential Health Risks
- Glenmark Generics Inc. Recalls Seven Lots of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg (Generic) Due to Possibility of Out of Sequence Tablets
- American Regent Initiates Nationwide Voluntary Recall Of Phenylephrine HCl Injection, USP, 1% 5 mL Vial, Lot# 0693 Due To Visible Particles
- McNeil Consumer Healthcare Announces Voluntary Nationwide Recall of Infants’ TYLENOL Oral Suspension, 1 oz. Grape Due to Dosing System Complaints
- Bedford Laboratories Issues Nationwide Voluntary Recall of Cytarabine for Injection, USP, 1 Gram per Vial
- Regeneca, Inc. Issues A Voluntary Nationwide Recall Of A Specific Lot Of RegenArouse Because Of Potential Health Risks
- Wholistic Herbs, Inc. Recalls “Koff & Kold” and “Kold Sore” Because Of Possible Health Risk
- North American Rescue, LLC Announces A Follow-Up to the Recall of Crickit Convenience Kits Related to Nationwide Recall of Triad Povidone Iodine Prep Pads 22
- February 02, 2012 Bedford Laboratories Issues A Voluntary Nationwide Patient Level Recall Of Acetylcysteine Solution, USP, LOT 1877093
- Pfizer Recalls Lo/Ovral-28 and Norgestrel/Ethinyl Estradiol Tablets Due to Possibility of Inexact Tablet Counts or Out of Sequence Tablets
- One Lot of Aveeno Baby Calming Comfort Lotion Recalled
- Cephalon, Inc. recalls Treanda® (bendamustine HCL) for Injection 25mg/Vial Due to Particulate Matter
- Perfect Image Solutions, LLC Issues Voluntary Recall of Unapproved Product Due to Potential Health Risk
- Bedford Laboratories Issues Guidance On 2011 Voluntary Recall Of Polymyxin B For Injection USP And Vecuronium Bromide For Injection Related To Glass Particles
- Novartis Consumer Health Inc. Recalls Certain Over-The-Counter Products Due to Potential Presence Of Foreign Tablets Or Chipped Or Broken Tablets Or Gelcaps
