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Johnson & Johnson has issued a recall of over 400 injection pens in the United States and Germany due to a manufacturing defect. This is the fourth recall in recent weeks by Johnson & Johnson, which certainly poses a question mark on the products manufactured by the New Jersey-based company.
The latest recall concerns the Simponi injection devices, which have a possible manufacturing defect because of which patients might receive an insufficient dose of the Simponi rheumatoid arthritis drug, which is developed by Centocor Ortho Biotech of Horsham, a Johnson & Johnson subsidiary. Johnson & Johnson claims to have discovered the problem in routine quality testing in Switzerland.
It has also withheld any further shipments of the injection devices, which is likely to cause a temporary shortage in European markets where patients are being advised to use Simponi’s pre-filled syringes. The company estimates that it has a failure rate of 0.5 percent, which means that the batch of Simponi injections containing 230 devices in Europe might have 1 faulty pen.
The defective devices, numbering 165 in the United States and 230 in Germany, are being recalled from pharmacies and doctor’s offices.
Since it was first marketed in 2009, Simponi has become quite popular with those affected with rheumatoid arthritis, active ankylosing spondylitis, active psoriatic arthritis, and other inflammations. The pre-filled pens make it easier for patients to receive the drug dose. They can simply press a button to receive the rheumatoid arthritis dose. It can be injected through prefilled syringes as well. Patients in Europe will feel shortage of these pre-filled pens until May, though these will become available by the end of this month at some places. New patients are advised not to start taking the drug through the pre-filled pens until any further notice from the manufacturer.
Of late, Johnson & Johnson has recalled four of its products, with the Simponi recall being the latest. Manufacturing-quality lapses have been found to be the primary reason for the maximum number of recalls by the company.
Earlier, J&J recalled 70,000 syringes preloaded with Invega anti- schizophrenia drug due to a manufacturing defect. The syringes were found to have cracks, thus posing the risk of infections. Patients also risked receiving inadequate doses of the drug due to the cracks in the syringes.
Before that, it recalled Secure Strap hernia treatment products due to defective packaging. It also had to recall discolored vials of its Dermabond liquid wound care products.
Last year, Johnson & Johnson recalled 40 consumer products, besides artificial hips, over-the-counter children’s medicines, Tylenol and Motrin pain pills, and contact lenses. In January, it recalled 43 million bottles of Benadryl, Sinutab, Tylenol, and Sudafed products. The reason for the recall was that the products were made at a time when the equipment might not have been properly cleaned during manufacturing at its Ft. Washington, Pa., plant. In December 2009, it recalled Tylenol 8-Hour caplets bottles because of a musky, musty odor, after symptoms, such as stomach pain, vomiting nausea, and diarrhea, were reported.
It also retracted more than 4 million units of Rolaids because of a labeling problem. Johnson & Johnson also recalled Rolaids Multi-Symptom Plus Anti-Gas Softchews, Rolaids Extra Strength Plus Gas Softchews, Rolaids Extra Strength Softchews following repeated complaints from consumers of foreign-particle contamination.
The company recalled one AlternaGEL product and dozens of Mylanta liquid products because of mislabeling. The company admitted that the products had been mislabeled to delete the presence of a small dose of alcohol. Three Tylenol Cold Multi-Symptom products were also recalled citing the same reason.
Johnson & Johnson recalled daily-use contact lenses in Japan because of traces of an acid that could cause stinging. The company clarified that the lenses made in the United States were safe.
The company’s subsidiary DePuy Orthopedics recalled two of its hip implants because more people than expected reported having undergone replacement surgeries. The same month, it recalled about hundred thousand 1-Day Acuvue TruEye contact lenses. This recall was recently widened. Lawsuit Attorneys have filed lawsuits
What the Company Says About the Latest Recalls
Johnson & Johnson claims that all the recent recalls are unrelated, as all these products are manufactured by different companies. The company also clarifies that this is not the “last” recall, which means it still fears loopholes somewhere.
Johnson & Johnson’s Responsibility
Being such a renowned manufacturer of health products, the company is expected to practice extra caution so that all of its products that leave its manufacturing units should be safe and sound, without any inherent defect. It is the manufacturer’s responsibility that all of its products do not have any inherent defects before they are sold in the market.
Such recalls dampen consumer confidence and hurt the people’s sentiments because consumers expect Johnson & Johnson products to meet world-class quality standards. Manufacturing deficiencies affect the quality and purity of medicines. With more than 40 recalls, Johnson & Johnson is creating the impression that it does not exercise tight control over its manufacturing units. After every recall, we are forced to ask whether the world’s biggest health care giant doesn’t exercise quality control over its manufacturing segments.
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