Philadelphia Defective Pharmaceutical Attorneys Report on Recent Drug Recalls for Defective Packaging and Labeling Errors

Defective Drug Lawyers Explain the Role of the FDA and Drug Recalls

The Food and Drug Administration (FDA) is responsible for testing the safety and effectiveness of new drugs before they can be approved for patient use.  setting the guidelines for the packaging and labeling of both prescription and over-the-counter drugs.  Despite having standards in place, dangerous drugs and defective medical products and devices are still distributed to consumers causing patients to suffer from adverse health consequences, pain, or even death.  A drug recall may be recommended by the FDA to remove a drug that is considered to be defective or harmful.  In some instances, a recall can pertain to the packaging or labeling of a drug even if the drug itself poses no health risk to the consumers.  A drug recall can be cause for alarm when they have the potential to cause catastrophic life-altering events for patients and their families.

Massive Infant Tylenol Recall Due to Defective Dosing System

Infant Tylenol oral suspension is an over-the-counter medication that is used to reduce fever or minor aches and pains in children.  The active ingredient in Tylenol is acetaminophen.  Taking more than the recommended dose of acetaminophen may cause severe liver damage or even death. 

Recently, Johnson & Johnson’s McNeil Consumer Healthcare issued a recall of 574,000 bottles of the 1 oz. grape flavored Infant Tylenol that were distributed throughout the United States.  This is just the latest recall for the company that has had numerous products recalled in the last several years, in some cases after disastrous consequences. In fact, in January, 2012, our Phildelphia defective drugs attorneys at Messa & Associates filed a Children’s Tylenol lawsuit for the death of a two-year-old boy after he ingested tainted Tylenol from a recalled lot.  After developing a fever, his parents gave him the recommended dose of Children’s Tylenol.  After 30 minutes, the toddler began spitting up blood.  He was immediately rushed to the hospital where he died the following day from liver failure. 

This most recent recall was initiated as a precaution after several consumers complained about the defective SimpleMeasure dosing system.  This system was designed as a safety improvement to help caregivers measure the precise dose.  SimpleMeasure dosing involves a parent or guardian using an enclosed dosing syringe, and inserting it into a pinhole in the protective cover referred to as a “flow restrictor” at the top of the bottle.  After turning the bottle upside down, the proper amount of medicine would be withdrawn into the syringe.  Reports were made that the flow restrictor was pushed into the bottle when the syringe was inserted through the small hole in the flow restrictor.  The use of this defective product may lead to improper dosing, which could cause infant injury or even death. 

Packaging Error Leads to Birth Control Recall

Millions of women take birth control pills on a daily basis as their primary method of contraception.  A recent recall of Norgestimate and Ethinyl Estradiol oral contraceptives is cause for alarm for any individual who was relying on these medications to prevent a pregnancy.  Due to a packaging error, the drug manufacturer Glenmark Generics issued a recall of seven (7) lots of the drug.   The packets of these pills were distributed nationwide from September 21, 2011 and December 30, 2011.

The packaging error caused the tablets in the pack to be rotated 180 degrees resulting in the sequential order of the pills to be incorrect.  In addition to the tablets being in the wrong order, the lot number and expiration date were only visible on the outer pouch.   The company stated that no health risks existed for those taking the pills, but urged the women to use another form of contraception.  For the women who took the pills in the incorrect order, they were left with inadequate contraception and at risk for an unexpected pregnancy.  Any failure or wrong dose of birth control pills can lead to an unintended pregnancy with the potential to cause physical, emotional, and financial distress on the mother.

This case follows two other recent birth control pill recalls.  Nearly 1 million Pfizer birth control pills were recalled because of a packaging error.  The tablets were distributed with some packets having the pills out of order while other packets had too many or too little of the active tablets.  Qualitest Pharmaceuticals had to recall multiple lots of birth control pills.  This was also related to a packaging error.  The tablets in these packs were arranged in reverse order as well as both the lot number and expiration date being obscured.  Women who trusted that these products would prevent an unplanned pregnancy were now at risk.

Labeling Error on Sinus Medication Cause for Safety Concerns

A recent drug recall of the combo pack of Rexall Extra Strength Sinus Relief Daytime and Nighttime Caplets manufactured by Vita Health Products was initiated due to a labeling error. Erroneous labeling identifies the daytime pills as the nighttime pills, and the nighttime pills as the daytime pills.  Taking one of the daytime caplets at night would not pose a problem, but ingesting one of the nighttime caplets during the day raises some safety concerns.  One of the active ingredients in the nighttime pills is diphenhydramine hydrochloride, which is used as a sleep aid.  Taking one of these pills during the day can cause sleepiness or drowsiness.  This sedative effect may make consumers taking the mislabeled pills more prone to serious accidents or injuries where they need to be alert, such as driving or operating machinery.

Messa & Associates – Defective Drug and Medical Device Lawyers in Pennsylvania and New Jersey

If you believe that you or a loved one has been harmed by taking a recalled prescription or over-the-counter medication, and would like your case to be reviewed by a defective drug lawyer with extensive experience with defective drugs and medical devices, contact the Philadelphia personal injury lawyers at Messa & Associates.  Our team of distinguished Pennsylvania and New Jersey attorneys are committed to protecting the legal rights of those adversely affected by dangerous or defective drugs and medical devices, as well as any other type of personal injury.  We have successfully litigated many catastrophic injury cases resulting in large settlements and verdicts that justly compensate our clients for their injuries. Call our defective drug attorneys at Messa & Associates toll free at 1-877-637-7252 or submit a free online inquiry.