Drugmaker Novartis is voluntarily recalling 1,645 lots of the four products. All four of the recalled products — as well as nine prescription opiate painkillers including Percocet and morphine — were made at the same plant in Lincoln, Neb. The opiate painkillers are made at the Novartis plant for Endo Pharmaceuticals.
At a news teleconference, Edward Cox, MD, director of the FDA’s office of antiviral products, said there was a slight but real risk that opiate prescription drugs could end up in the over-the-counter products.
“There is a potential risk that it could happen,” Cox said. “That is the reason for the consumer-level recall, because there is the potential for a product mix-up there.”
Packages of each of the brands may contain tablets, caplets, or capsules of other products. Some of the pills may be broken or chipped.
All Bufferin products with expiration dates of Dec. 20, 2013, or earlier have been recalled. Brand names include Bufferin Extra Strength Tablets, Bufferin Low Dose Tablets, and Bufferin Regular Strength Tablets.
All Gas-X Prevention products with expiration dates of Dec. 20, 2013, or earlier have been recalled.
The following Excedrin products with expiration dates of Dec. 20, 2014, have been recalled:
Excedrin Extra Strength Caplets
Excedrin Extra Strength Express Gel Caplets
Excedrin Extra Strength Gel Caplets
Excedrin Extra Strength Tablets
Excedrin Back & Body Caplets
Excedrin Sinus Headache Caplets
Excedrin Migraine Caplets
Excedrin Migraine Gel Tablets
Excedrin Migraine Tablets
Excedrin Menstrual Complete Express Gel Caplets
Excedrin PM Caplets
Excedrin PM Express Gel Caplets
Excedrin PM Tablets
Excedrin Tension Headache Caplets
Excedrin Tension Headache Express Gel Caplets
Excedrin Tension Headache Gel Tablets
The recalled products were distributed throughout the United States, but not internationally.
There have been no reports of illness or injury from the products.
“Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient,” Novartis warns. “This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient.”
Consumers who have the recalled products should stop using them and contact Novartis (888-477-2403 or novartisOTC.com) for information on returning them for a refund.
People who may have had adverse events related to the products should report them to the FDA’s MedWatch program (www.fda.gov/medwatch/report.htm).
FDA: Plant Problems Date to ‘at Least 2009’
In a statement, Novartis says it confirmed the problem during an internal product review following customer complaints. According to an FDA inspection report dated June 13 to July 8, 2011, those complaints have been coming in since “since at least 2009.”
In the report, FDA inspectors blast plant management for failing to investigate numerous consumer complaints. The inspectors note that Novartis blamed pill mix-ups on “product pilfering” or on events that happened after the pills left the plant. The report says there was no evidence to support these conclusions.
Endo says it has received only three complaints of pill mix-ups. All three were caught by pharmacists before the drugs were given to patients. Endo officials were not mentioned in the June/July 2011 FDA inspection report.
Late last year, Novartis suspended operations at the plant “to accelerate maintenance and other improvement activities at the site,” according to a company news release.
It’s not yet clear whether there will be shortages of any of the recalled over-the-counter drugs. But Endo says it expects to see shortages of some of its opiate pain medications. Fortunately, the FDA says alternative versions of each medication are still available.
Prescription Pain Drug Mix-Up
The following Endo Pharmaceutical products may have been affected by the packaging problem.
Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII
Opana (oxymorphone hydrochloride) CII
Oxymorphone Hydrochloride Tablets CII
Percocet (oxycodone hydrochloride and acetaminophen USP) Tablets CII
Percodan (oxycodone hydrochloride and aspirin, USP) Tablets CII
Endocet (oxycodone hydrochloride and acetaminophen USP) Tablets CII
Endodan (oxycodone hydrochloride and aspirin, USP) Tablets CII
Morphine Sulfate Extended-Release Tablets CII
Zydone (hydrocodone bitartrate/acetaminophen tablets, USP) CIII
The FDA is asking people who take prescription pain medications to take a closer look at their pills before swallowing them.
“We are asking patients to check their medicines and to look for tablets of a different size, shape, or color from their regular medicine,” says Cox. “If they find any tablets that are different from the rest, they should stop taking their pain medicine and take the medicine to their pharmacy.”
Endo Pharmaceuticals has issued a visual guide to help people identify pain pills at www.endo.com/pdf/Supply_disruption/Visual_Guide.pdf.
FDA officials say the likelihood of finding the wrong tablet in a prescription pain medication is low. In most cases, any potential pill mix-up would first be detected by a pharmacist.
Therefore, after considering the public health risks and benefits, the FDA decided a recall of the prescription pain medications was not necessary.
By Daniel J. DeNoonAnd Jennifer WarnerWebMD Health News
Reviewed by Laura J. Martin, MD