Supply Shortage and Rare Tablet Mix-up
Production of certain products has been temporarily suspended by our contract manufacturer in order for the manufacturer to implement manufacturing process improvements. These improvements are intended to address rare instances of errors in the packaging of the tablets, potentially resulting in product mix-ups. Endo is aware of only three product mix-ups with respect to these products since 2009, of which all three were detected by pharmacists. We are not aware of any patient having experienced a confirmed product mix-up and there have been no adverse events attributable to a product mix-up. We believe the likelihood of product mix-up reaching a patient is remote.
As a result of the implementation of these improvements, we anticipate that there may be a short-term disruption in the supply of these products to patients. This temporary supply disruption is not related to the efficacy or safety of these products.
Endo’s primary concerns are the health, well-being, and continuity of care for patients.
For patients currently prescribed any of the following products, a visual guide (PDF) has been provided to verify the appearance of these products. Please review the product name of your prescription to confirm the tablets in your prescription match the tablet images provided:
- OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets CII
- OPANA® (oxymorphone hydrochloride) Tablets CII
- VOLTAREN(R) Gel (diclofenac sodium topical gel) 1%
- 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
Click here to access the visual guide