Status
Terminated
Drug Enforcement D-66458-1
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.
Classification
Class II
Report Date
November 13, 2013
Termination Date
July 7, 2014
Product Information
- Product description
- 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
- Product quantity
- 692 bottles (90 count)
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Sandoz, Inc
- Address
-
506 Carnegie Ctr Ste 400, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-66458-1
- Event ID
- 66458
- Recall initiation date
- October 9, 2013
- Center classification date
- November 4, 2013
- Code info
- Lot DJ2744, Exp 12/2014
- More code info
- —