Recalled Lyrica Damaged By 'Extreme Heat'

By Pat Anson, Editor

Nearly 150,000 bottles of Lyrica are being recalled by Pfizer in the United States and Puerto Rico because they may have been damaged by "extreme heat" while being transported, Pain News Network has learned. Each bottle contains 90 capsules.

Pfizer ordered the recall of its blockbuster pain drug on January 11 and notified retailers that may have been shipped the damaged capsules, but made no effort to tell patients about the recall because the problem did not appear serious, according to the company. PNN learned about the recall when a “Dear Customer” letter sent to retailers surfaced.

“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. Please note that the use of, or exposure to, this product is not likely to cause adverse health consequences,” the company said in a statement to PNN.

The Lyrica capsules were manufactured at a Pfizer facility in Freiburg, Germany and shipped to U.S. wholesalers in September or October of last year. Pfizer said it learned some of the capsules were damaged in mid-December.

"We believe this was a result of exposure to extreme heat during transit," the company said. “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 Pfizer’s top selling drug, generates over $5 billion in annual sales, and is currently approved for use in over 130 countries. In the U.S. Lyrica is approved to treat epilepsy, diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles, and spinal cord injury. It is also widely prescribed “off label” to treat a variety of other conditions, including lumbar spinal stenosis, the most common type of lower back pain in older adults. Lyrica is the brand name of pregabalin, which was originally developed as an anti-seizure medication.

Three lots of Lyrica are being recalled. They include 50 mg capsules in 90-count bottles, Lot #M07861 and with an expiration date of 5/31/2018. Two lots of 75 mg capsules in 90-count bottles are also being recalled. Their lot numbers are #M07862 and #M07865, with expiration dates of 5/31/2018 and 6/30/2018.

Pfizer issued no press releases about the recall and there is no mention of it on the company’s Lyrica website or the Food and Drug Administration's website that lists recalled products. 

Pfizer says the manner in which it conducted the recall was approved by the FDA’s New York District Office. The company proposed that it be classified as a Class III recall, which the FDA defines as “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”

“Recalls are actions taken by a firm to remove a product from the market.  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,” said Stephen King, an FDA spokesman who said the agency was still evaluating the effectiveness of the recall.

“Not all recalls are announced in the media or on our Recalls press release page.  FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard.”

Pfizer ordered the Lyrica recall just days after raising the listed price of the pain drug by 9.4 percent. Prices were also raised on over 100 of the company’s other drugs. Pfizer’s pharmaceutical division reported revenue of $45.7 billion in 2014.