Recalls / Class II
Class IID-66458-1
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
- Affected lot / code info
- Lot DJ2744, Exp 12/2014
Why it was recalled
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.
Recalling firm
- Firm
- Sandoz, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 506 Carnegie Ctr Ste 400, N/A, Princeton, New Jersey 08540-6243
Distribution
- Quantity
- 692 bottles (90 count)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-10-09
- FDA classified
- 2013-11-04
- Posted by FDA
- 2013-11-13
- Terminated
- 2014-07-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-66458-1. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.