Pfizer has recalled almost 150,000 bottles of Lyrica – a best-seller used to treat nerve pain – after learning that the pharmaceuticals may have been exposed to extreme heat during transportation, leading to damage. The recalled pharmaceuticals include three lots, with each bottle containing 90 capsules.
According to Pfizer, the heat damage is not expected to have presented a health risk to patients taking Lyrica, and the recall was undertaken voluntarily as a precaution. The company notified retailers about the potentially-damaged capsules on January 11.
“Even though the patient impact and safety risk are low, Pfizer has decided, out of an abundance of caution, to voluntarily recall three lots of Lyrica capsules at the retail level due to the potential presence of deformed or damaged capsules,” said a spokesperson for Pfizer in a statement to Pain News Network. “Please note that the use of, or exposure to, this product is not likely to cause adverse health consequences.”
The Lyrica capsules in question were manufactured in Germany and shipped to wholesale facilities in the US and Puerto Rico. The company says they learned of the heat damage of the three lots in December of 2015.
“We believe this was a result of exposure to extreme heat during transit,” said a spokesperson from Pfizer. “Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. There is no anticipated impact on supply. Pfizer will continue to meet product demand based on U.S. prescriptions.”
Lyrica is a true blockbuster for Pfizer, bringing in more than $5 billion in sales each year. While the drug is approved for use in more than 130 countries, the US Food and Drug Administration (FDA) has approved Lyrica for patients with diabetic nerve pain, epilepsy, fibromyalgia, spinal cord injury and post-herpetic neuralgia caused by shingles.
The drug is also prescribed for a number of so-called “off-label” indications, including the most prevalent form of lower back pain in older adults: lumbar spinal stenosis. Pregabalin – the generic name for Lyrica – was developed as an antispasmodic to prevent seizures.
Pfizer has not issued any press releases regarding the recalled batched of Lyrica, nor has the FDA posted it on their list of recalled drug products. The recall comes just days after the price of Lyrica was increased by 9.4 percent.
“Recalls are actions taken by a firm to remove a product from the market,” said Stephen King, an FDA spokesman. “Only in rare cases will FDA request a recall. FDA’s role is to oversee a company’s strategy and assess the adequacy of the recall.”
“Not all recalls are announced in the media or on our Recalls press release page,” said King. “FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard.”