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Biovail Recalls Ultram Painkiller

Dec 31, 2008 | Parker Waichman Alonso LLP

Some lots of Ultram® ER 100mg tablets are being recalled.  Toronto-based pharmaceutical company Biovail Corporation is voluntarily recalling some lots of the painkillers—generically known as extended-release tramadol hydrochloride—from pharmacies and wholesalers after finding that certain batches were found to be “out-of-specification” by about one percent regarding “maximum dissolution at the eight-hour mark,” said Fierce Biotech.

The specification variance concerns the rate at which the medication dissolves.  RTT News explained that that Ultram uses a so-called “Smartcoat” technology that is designed to release the once-daily pain medication throughout the day.

The Canadian Press pointed out that an unspecified amount of Ultram ER tablets are involved in the recall; however the recall will likely reduce quarterly revenue by $4.4 million (U.S.) and add $3 million (U.S.) to inventory and administrative costs.   Biovail said, according to the Canadian Press, that the recall "does not impact patient health or safety," and no product shortages are expected at the drugstore level.  

It seems, said Biovail, that the Ultram ER problem stems from “excipients,” so-called inactive ingredients used to carry medicines’ active ingredients, according to the Canadian Press.  In this case, explained Biovail, the excipients were used in the coating process and "corrective measures are currently being implemented," reported the Canadian Press, which also pointed out that replacement shipments will be made to Biovail’s marketing partner, PriCara, which is a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Tramadol is a synthetic, prescription pain reliever that is similar to morphine in that it binds to opioid receptors in the brain to stop the sensation of pain, according to MedicineNet, which describes the most common side effects reported with Tramadol as being nausea, constipation, dizziness, headache, drowsiness, and vomiting; itching, sweating, dry mouth, diarrhea, rash visual disturbances, and vertigo have been reported, as have been seizures.  Anxiety, sweating, insomnia, rigors, pain nausea, diarrhea, tremors, and hallucinations can occur when tramadol is abruptly stopped, MedicineNet warns.

Ultram is used in cases of moderate to moderately severe chronic pain in adults, who need ongoing pain management for extended time frames, said RTT News.