Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92
FDA recall notice · announced November 13, 2013 · Sandoz
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92
Reason for recall
Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.
Notes
Distribution: Nationwide
Lot/code information: Lot DJ2744, Exp 12/2014
Quantity: 692 bottles (90 count)
Status: Terminated
Products in this recall event:
- Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92 (D-66458-1)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.