Recall on Popular Topical Cream the Result of Manufacturing Defects

If you use a popular over-the-counter ointment as a topical pain reliever, some news about the manufacturer’s voluntary product recall should be cause for concern. An August 31, 2021, article in the Miami Herald contains some important information about the move by Teligent Pharma, which found during its own testing that a batch of Lidocaine HCl Topical Solution contained excessively high levels of its main ingredient. The dosage would be considered “super potent” and too strong for the patient, potentially leading to life-threatening consequences. 

The news article includes information on the pharmaceutical company’s instructions related to the recall, but it is also important as a way of understanding how manufacturing defects work. A Miami products liability attorney can explain the details, and an overview is informative.

Details of the Lidocaine Recall

The specific product involved with the Teligent’s recall is Lidocaine HCl Topical Solution 4%, 50 ml container. Only one lot was affected, with an expiration date of September 2022. The bottle is clear glass with a screw cap, and individuals can return it to the place of purchase for a full refund. In addition, the manufacturer stated that anyone who experienced an adverse reaction should inform the FDA via its website.

The concern with the super potent lidocaine is that it may lead to a medical condition termed local anesthetic systemic toxicity. This is a serious disorder that can cause various issues for the central nervous system, including:

  • Agitation, depression, and other extreme mood swings;
  • Cardiovascular toxicity, such as hypotension – i.e., dangerously low blood pressure;
  • Cardiovascular collapse; and,
  • Death.

How Manufacturing Defects Make Products Dangerous

An important point to note about the lidocaine recall is that only one lot was made super potent, creating a manufacturing defect. All other batches, which were produced in accordance with the formula established by the pharmaceutical company, would be suitable for use.

Design defects may also be grounds for products liability, but the underlying legal concepts are different. When a flaw becomes part of the item’s blueprint, ALL products created in that image will be defective. A manufacturer would have to issue a blanket recall covering all items produced with the flaw. Another basis for products liability claims is the failure to warn, sometimes termed labelling defects. With these cases, the flaw is the information printed or included with the product. It may omit warnings, lack safety instructions, or otherwise fail to make the product safe for use.

Speak to a Miami Products Liability Lawyer About Your Options

This summary of Florida law on manufacturing defects is helpful, but the legal process can be complicated. Products liability cases often impact large groups of people who suffer similar injuries, so there is the possibility that your claim could become part of a class action. Our team at Gerson & Schwartz, PA can advise you on your remedies, so please contact our firm to schedule a free consultation. Our products liability attorneys can meet with you at our offices in Miami, Fort Lauderdale, or West Palm Beach, FL.

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