By Pat Anson, Editor
Pfizer has quietly recalled three lots of its blockbuster drug Lyrica because of a manufacturing problem that could have left some capsules deformed or damaged. The voluntary recall only involves 50 mg and 75 mg Lyrica capsules with a certain lot number and expiration date.
“Please note that use of, or exposure to, product from these lots is not likely to cause health consequences,” said Lou Dallago, Vice-President of Pfizer’s U.S. Trade Group, in a “Dear Customer” letter sent to retailers who may have received a shipment of the recalled Lyrica lots in September or October 2015.
The letter is dated January 11, 2016 and is stamped “Urgent: Drug Recall.”
Pfizer has not publicized or notified patients directly about the recall. The drug maker has issued no press releases about the recall and there is no mention of it on Pfizer’s Lyrica website or the Food and Drug Administration's website that lists recalled products.
(An update to this story can be found by clicking here).
“The recall was initiated because some Lyrica capsules in the affected lots may be deformed or damaged,” GoodRx.com reported. “This can affect the integrity of the medication in those capsules, which means they could lose some of the active ingredient—so you may or may not be getting the full dose with each capsule. If you don’t receive the correct dose, your prescription may not be as effective.”
Lyrica is the brand name of pregabalin, which was originally developed as an anti-seizure medication to treat epilepsy. Lyrica is also approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injury. Lyrica is 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.
The recalled Lyrica includes 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.
Lyrica is Pfizer’s top selling drug, generates over $5 billion in annual sales, and is currently approved for use in over 130 countries. Last year Pfizer agreed to pay $400 million to settle a shareholder lawsuit over allegations it illegally marketed Lyrica and several other drugs off-label. The lawsuit stemmed from a $2.3 billion settlement with the federal government in 2009 for fraudulent marketing and illegal kickbacks paid to doctors who prescribed Lyrica and other Pfizer products.