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Recall Observatory FDA recall evidence

Drug 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

D-66458-1

October 09, 2013

Class II

Product summary

Firm
Sandoz, Inc
Event
Event 66458
Status
Terminated
Classification
Class II
Quantity
692 bottles (90 count)
Official record key
drug-enforcement:D-66458-1

Official wording

Reason: 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.

Code information: Lot DJ2744, Exp 12/2014

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.