Recalls

Before a prescription medication can be approved by the U.S. Food and Drug Administration, it must go through a rigorous series of tests and clinical trials in order to determine if the drug poses any serious threats to its users. Sometimes certain drugs do not immediately present side effects or symptoms of health threats, and they are approved while still needing further observation. If a drug poses serious detriment to the general public, and has a propensity to cause serious, irreversible damage to the health of users, consumers and patients, then the FDA will declare a recall of that drug.

Unfortunately, simply recalling a drug does not make up for the damage that it has already caused to the health of consumers. DrugAlert.org provides timely and accurate information regarding FDA investigations, black box warnings, and especially prescription medication recalls.

Hospira Recalled Due to Incorrect Drug Volume, Potential Overdoses

The U.S. Food and Drug Administration (FDA) recently announced the nationwide voluntary recall of a lot of Hospira, a hydromorphone hydrochloride injection.  According to the announcement, this recall has been initiated due to two reports of single drug delivery cartridges containing more than the 1 mL volume of the labeled medication. 

These Hospira cartridges are part of the Carpuject Syringe System, which consists of prefilled glass cartridges that are loaded into a syringe holder to deliver the drug.  This system is intended to provide an easy, safe, convenient, and time-saving method of delivering this medication. 

However, the FDA explains that opioid pain medications such as hydromorphone have life-threatening overdose consequences which include the following:

  • Respiratory depression-slowed or suspended breathing
  • Low blood pressure
  • Reduced heart rate and circulatory collapse

The faulty lot was distributed from September to October of 2011 and has the lot number 07547LL.  The expiration date for this lot is July 1, 2013.  The medication was first distributed to wholesalers and some hospitals in the following locations: Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin.

Although the drug’s manufacturer, Hospira, Inc., says they have not yet received any adverse event reports related to this lot defect, they have begun an investigation to coincide with this recall.  Through this investigation, the manufacturer hopes to determine the root cause of this defect, as well as determine any preventative actions that need to take place. 

The recall announcement explains that anyone who experiences problems that may be related to this medication is encouraged to contact their physician or healthcare provider to report these issues.  Furthermore, anyone possessing this medication is instructed to stop using or distributing it and to quarantine what they have. 

Individuals are then instructed to call Stericycle at 1-888-912-7093 to arrange the return of the product.  The FDA explains that replacements from safe lots of this medication are available to customers and can be received by sending their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083.

Mislabeled Warfarin Bottles Recalled because of Overdose Risks

The FDA has issued a recall of a single lot of the drug warfarin, an anti-coagulant often prescribed to prevent the formation of blood clots.  The recalled bottles are mislabeled as containing 3 mg of the drug, when in fact they contain 10 mg tablets – more than three times the labeled dose.  An overdose of this drug can lead to dangerously uncontrolled bleeding.

A single bottle of Jantoven Warfarin Sodium, USP, was found to contain the wrong dosage.  Though no more mislabeled bottles have yet been discovered, manufacturer Upsher-Smith Laboratories issued a recall on February 17 of all bottles from lot #284081.  On February 21, the FDA expanded the recall to other brand names of warfarin: Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, and Oxybutynin.  These products have been sold to family practice doctors and individual consumers through wholesalers as well as retail chain and independent pharmacies across the U.S.

Blood clots that form inside a blood vessel can lead to thrombosis, an obstruction of blood flow.  If this clot breaks free, it can cause an embolism, blocking most or all of the circulation to a certain part of the body.  If the embolism occurs near the heart or lungs, it can be fatal.  Even embolisms at other sites, if left untreated, can cause tissue death from lack of blood.  Warfarin thins the blood, which keeps these clots from forming, but also prevents the body from stopping the flow of blood from a cut or other injury.  Too great a dose of warfarin greatly increases the risk of life-threatening hemorrhage.

The tablets themselves are labeled correctly, imprinted with the number 10.  Additionally, the 10 mg tablets are white, whereas the 3 mg tablets are tan, though both also feature the letters WRF and the number 832 on the reverse.  Pictures of the tablets, as well as further details on the recall, are available at the FDA’s website.   Doctors, patients, or pharmacists who have these mislabeled bottles are urged to call Upsher-Smith’s medical information line at 1-888-650-3789 from Monday through Friday between the hours of 8:00 am and 5:00 pm, EST.

Reference:

U.S. Food and Drug Administration. (February 21, 2011) “Warfarin sodium tablets (Jantoven), 3 mg: Recall – mislabeled bottles containing higher dosage.” Retrieved March 3, 2011 from FDA.gov.

“Phantom” Drug Recall Leads to Oregon Suit against J&J

A CNN Money article reports that the state of Oregon “has sued Johnson & Johnson for allegedly selling defective Motrin drugs to consumers in the state for more than a year, and for trying to secretly remove the faulty drugs from stores.” The Attorney General of Oregon, John Kroger, said “‘Companies that break the rules and put consumers at risk will be held accountable,’” CNN explains.

Included in the lawsuit are J&J “and its two subsidiaries, McNeil PPC Inc. and McNeil Healthcare Inc,” the article explains. CNN further reports that J&J’s “McNeil division makes over-the-counter cold and pain drugs such as Tylenol, Motrin and Benadryl.”

According to the suit, in late 2008 J&J learned some of its Motrin medication batches were defective, failing to properly dissolve, the article reports. CNN explains that these drugs were sold in convenience stores and gas stations. However, the article explains, instead of initiating “a public recall of the defective Motrin products, the suit alleges that J&J hired contractors to go into stores in early 2009 and secretly buy the faulty products without telling wholesalers, retailers or consumers about the problem.”

Calling it a “phantom” recall, “the suit alleges that J&J's McNeil division did not publicly announce a recall until February 2010,” despite the Food and Drug Administration’s awareness of the issue, CNN explains. According to the news story, the public initially heard of the recall “when details of it emerged in June during a Congressional hearing addressing a series of other Johnson & Johnson recalls. “

CNN explains that after that hearing, company executives and the FDA began receiving questions about the secretive recall. However, the company maintained for months that no deceptive actions in the recall took place, CNN reports. It was not until December that the J&J CEO, William Weldon, “admitted to lawmakers… J&J secretly bought up defective drugs without informing regulators and consumers of its actions,” the article explains.

This suit, filed by the state of Oregon, alleges “that despite the secret Motrin removal, more than 787 eight-count containers of the allegedly defective Motrin remained in stores for sale in the state,” CNN reports. In addition, the article explains that J&J violated “Oregon’s Unlawful Trade Practices Act (UTPA), which prohibits companies from ‘employing unconscionable tactics, making certain false or misleading representations, or failing to disclose a fact.’”

The article continues, stating that Oregon “is suing J&J for civil penalties of up to $25,000 for each violation of the UTPA, which could amount to millions of dollars.” This lawsuit comes after J&J rejected a settlement “which included a payment of $725,000 by J&J to the Justice Department to settle the dispute,” CNN reports.

CNN explains that McNeil called theirs a “limited recall,” alleging their actions were “‘consistent with applicable law and there was no health or safety risk to consumers.’” The article reports that the company said they “‘intend to seek dismissal of the [c]omplaint.’”

References:

Kavilanz, Parija. (January 13, 2011) “Oregon sues Motrin maker over secret drug recall.” Retrieved on January 14, 2011 from CNN

FDA: Fracture and Peeling Risk Leads To Angioplasty Catheter Recall

The FDA has issued a Class I recall of AngioSculpt PTA Scoring Balloon Catheters sold between September of 2007 and November of 2010, noting that they pose a risk of serious injury or death from a design flaw which could result in “unintended fracture or peeling.”  

More than 17,000 units have been recalled by AngioScore Inc., the manufacturer of the defective catheters.  The company distributed letters to its U.S. customers on November 15, 2010, listing the reason for the recall as “potential harm to patients,” reports the FDA.  All sizes and lots of the following model numbers are included in the recall: 2076-4020, 2076-5020, 2076-6020, 2092-6020, and 2105-6020.

An angioplasty involves the insertion of an empty balloon-like tube, known as a balloon catheter, into a blood vessel.  The catheter is then inflated with water, widening the vessel, crushing obstructions, and improving blood flow.  The defective AngioSculpt catheters may break or peel during use, the FDA says, possibly damaging the blood vessels or even leaving fragments of the catheter behind after it is removed.  The recall notice explains that if this happens, additional surgical intervention may be necessary.

A Class I is the most serious type of recall, indicating that “the use of these products will cause serious adverse health consequences or death,” according to the report.   Though no deaths or severe injuries from using these catheters have been reported, in addition to immediately ceasing use of the product, the FDA advises customers to “examine their inventory, and quarantine all affected product.”  Customers can contact AngioScore Inc. at (877) 264-4692 for an inventory form to return the product or if they have questions about the recall.

Angioplasties are performed on patients who have significant blockage in one or more arteries, usually due to coronary artery disease.  According to WebMD, the procedure is non-surgical, usually performed by a cardiologist, and lasts about one and a half to two and a half hours, though the recovery time may require several hours after that.  The FDA notes that the AngioSculpt catheter can be used in arteries in the thigh, groin, abdomen, or knee “for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.”

References:

U.S. Food and Drug Administration. (January 5, 2011) “AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon CatheterOTW 0.018” Platform (multiple sizes).” Retrieved on January 7, 2011 from the FDA.

WebMD. (2009) “Heart Disease Treatment with Angioplasty and Stents” Retrieved on January 7, 2011 from WebMD.

FDA Initiates Albuterol Recall Over Mislabeling

A report released by the FDA on Monday announced the recall of mislabeled vials of Albuterol Sulfate Inhalation Solution.  The single-use, 2.5 mg/3 mL vials, produced by the Ritedose Corporation, “are embossed with the wrong concentration of 0.5 mg/3 mL and therefore, represents [sic] a potential significant health hazard,” says the FDA.

Though the foil overwrap pouches and shelf cartons display the correct concentration of the drug, the vials themselves bear incorrect labels which may lead doctors to mistakenly administer “5 times the recommended dose,” the report warns.  Because the outer layers of packaging are often removed when the vials are stocked in a hospital, the FDA claims it is likely that dosing errors could occur in this setting.

The Albuterol Sulfate solution is prescribed for both children and adults in the treatment of “acute asthma exacerbations and exercise induced asthma,” explains the FDA.  The drug is nebulized (aerosolized into a fine mist by a device called a nebulizer), then inhaled into the lungs. A CNN article about asthma lists albuterol among “rescue” or “quick-relief” asthma medications, which “are used as needed for rapid, short-term symptom relief during an asthma attack.”

An overdose could lead to albuterol toxicity, with symptoms the report lists as including “tremors, dizziness, nervousness, headache, seizures, angina, high blood pressure, low potassium levels, and rapid heart rates up to 200 beats [per] minute.”

The FDA advises consumers who have purchased the mislabeled vials to immediately return them to the doctor’s office, pharmacy, or other location where the drug was obtained.  Retailers and wholesalers who stock the solution “should return the product to the address stated in the firm Press Release,” says the report.   The press release also lists a phone number and e-mail address where customers can contact the Ritedose Corporation.

CNN’s asthma report outlines treatments for asthma, one of which is a group of “short-acting beta antagonists,” including albuterol.  These drugs are bronchiodilators, the report explains, and relieve sudden symptoms by helping to open the airways that bring oxygen into the lungs.  Though it may only take a few minutes for the beta-antagonists to take effect, the “effects last several hours,” says the article.

The FDA report explains the mislabeled product from the Ritedose Corporation “could result in a range of potential health effects that spans from temporary and medically reversible to life threatening and death.”

References:

CNN staff writer. (March 27, 2010) “Occupational Asthma.” Retrieved on January 4, 2011 from CNN.

U.S. Food and Drug Administration. (January 3, 2011) “Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall – Mislabeled Unit Dose Vials.” Retrieved on January 4, 2011 from the FDA.

Lundbeck Issues Recall Of Injectable Ibuprofen

The pharmaceutical company Lundbeck of Deerfield, Illinois recently announced a voluntary recall of NeoProfen, an injectable form of ibuprofen used for treating premature infants. The drug maker issued the recall due to visible particulates in the NeoProfen solution, Pharm Tech Talk reported.

The drug is used to treat a heart condition in premature infants known as patent ductus arteriosus. Lundbeck admitted in its recall notice that “The potential adverse events resulting from the use of a sterile injectable product with particulates can be very serious and potentially fatal,” the Pharm Tech Talk article reported.

Lundbeck has not yet received any notices of adverse effects from the use of NeoProfen, according to the recall notice statement. The FDA, wholesalers of the drug, hospitals and neonatologists have all received notification of the recall. Lundbeck reports that there will be a short-term shortage of NeoProfen while the company finishes the recall and manufactures new supplies, the Pharmaceutical Business Review reported.

Potential problems that could arise due to injections of a solution with visible particulates include obstruction of blood vessels, pulmonary emboli, anaphylactic shock, foreign body granulomas and irritation of blood vessels, according to a Med Page Today article.

References:

Pellek, Alexis. (August 5, 2010) “Lundbeck Voluntarily Recalls Injectable Ibuprofen Used to Treat Premature Infants.” Retrieved on August 6, 2010 from Pharm Tech Talk.

Petrochko, Cole. (August 2, 2010) “Injectable Ibuprofen Recalled.” Retrieved on August 6, 2010 from Med Page Today.

Pharmaceutical Business Review Staff: (August 2, 2010) “Lundbeck Voluntarily Recalls NeoProfen Injection.” Retrieved on August 6, 2010 from the Pharmaceutical Business Review.

Photo Credit: Premie in incubator by MikeBlyth.
 

Johnson & Johnson Announces Another Recall of Children’s Tylenol

Sales of Johnson & Johnson pain relievers have plummeted after a string of recalls have been announced. An eighth recall was announced on Thursday, as the company has lost tens of millions of dollars. Johnson & Johnson's McNeil consumer health care unit recalled 21 lots of products recently. One of the many products included was Children's Tylenol, which was also recalled earlier in January due to a nauseating chemical on shipping platforms. Since then sales of Children's Tylenol have dropped almost 96 percent.

Johnson & Johnson recalled more than 130 million bottles of children’s and infants’ liquid medicines in April, saying that the products "may not meet required quality standards.” These products may have contained dangerous excessive amounts of active ingredients or may even contain tiny metal particles. The recalls have been caused by a lack of quality control within the company itself.

A market research firm has shown that Johnson & Johnson pain reliever products in New Brunswick, NJ have fallen 56 percent compared to sales from a year earlier. Sales of store brand pain relievers have jumped 23 percent, and a decrease in the sales of products such as Tylenol and Motrin have placed Johnson & Johnson behind their rival companies Bayer and Wyeth.

Along with millions of dollars in revenue being lost, recalls of Johnson & Johnson pain relievers have damaged their reputation and will even come to hurt the sales of their iconic baby products and Band-Aids. The company has sent buyers coupons in hopes of bringing them back to the company, but judging by current sales trends, customers are not responding well.