The FDA has issued a public health advisory due to the potential accidental mixing of over-the-counter (OTC) medications with prescription opioid painkillers at Novartis Consumer Health’s Endo Pharmaceuticals plant in Lincoln, Nebraska.
Novartis press release announced that, they are “voluntarily recalling all lots of select bottle packaging configurations from retailers of Excedrin® and NoDoz® products with expiry dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X Prevention® products with expiry dates of December 20, 2013 or earlier, in the United States. NCH is taking this action as a precautionary measure, because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.”
Due to the mix-up FDA advises patients and healthcare professionals to examine opiate medicines made by Endo in their possession and ensure that all the tablets are the same. FDA and Endo are providing instructions on how to identify an incorrect tablet in these medicines.
According to Novartis, “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. 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.”
- 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
Endo Pharmaceuticals reports that they are aware of only three product mix-ups with respect to these products since 2009; all three were detected by pharmacists.
Consumers and customers in the US who have questions can call the Consumer Relationship Center ( Novartis ) at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time).
For more detailed information regarding the product, potential drug reactions, impacted configurations, related NDC numbers and expiry dates, visit their website starting January 9, 2012 at www.novartisOTC.com.
For more on the FDA warning go to FDA Public Health Advisory