Manufacturing problems at its Lincoln, Neb., production facility have forced Novartis Consumer Health Inc. to shut down the plant and issue a recall involving some commonly used OTC medications. In addition, the FDA has issued a warning regarding several opiate products produced at the plant.
According to a Jan. 8 press release(www.fda.gov) posted on the FDA website, Novartis is voluntarily recalling all lots of the OTC drugs Bufferin, Excedrin, Gas-X Prevention and NoDoz after receiving reports of chipped and broken pills, as well as "inconsistent bottle packaging clearance practices" at the Nebraska plant that could result in the bottles containing foreign tablets, caplets or capsules.
The possible mix-up of products in the bottles poses a risk that consumers could take an incorrect product, resulting in an overdose, an adverse interaction with other medications or an allergic reaction.
The FDA also is advising(www.fda.gov) health care professionals and patients about potential problems affecting various opiate products manufactured at Novartis' Nebraska plant for Endo Pharmaceuticals.
According to the agency's warning, pills, tablets or caplets of oxycodone and acetaminophen (marketed as Percocet), oxycodone and aspirin (marketed as Percodan), and seven other opiate products may have carried over into packaging of another of the products.
"This could result in a stray pill of one medicine ending up in the bottle of another product," the company said. "The likelihood of this occurring in medication dispensed to patients is estimated to be low."
According to Endo, mix-ups of this type have happened only three other times since 2009, all of which were detected by pharmacists before they reached consumers.
"Endo is not aware of any patient having experienced a confirmed product mix-up, nor any adverse events attributable to a product mix-up," Endo said in the FDA release. "Nonetheless, to ensure continued patient safety and access to these needed medicines, FDA advises patients and health care professionals to examine opiate medicines made by Endo in their possession and ensure that all tablets are the same."
Patients are encouraged to speak with their physician first if they have questions about these products, but they also are welcome to contact Novartis at (888) 477-2403 for information on how to return affected OTC products and Endo at (800) 462-3636 for help identifying whether a problem exists with their medication.
Adverse events that may be related to use of these products also may be reported to MedWatch(www.accessdata.fda.gov), the FDA's Safety information and Adverse Event Reporting Program.