The Recall Desk
SevereFDA (Drugs)·D-66458-1·Announced 2013-11-13

Sandoz Recalls Ropinirole Extended-Release Tablets Due to Cross-Contamination

Sandoz is recalling specific lots of Ropinirole Extended-Release Tablets 2 mg due to potential cross-contamination with mycophenolate mofetil.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe).

Plain-English summary

Sandoz, Inc. is recalling certain lots of Ropinirole Extended-Release Tablets, 2 mg, 90-count bottles. The recall is due to the potential presence of carryover from a previously manufactured product, mycophenolate mofetil.

The affected product is identified by Lot DJ2744 with an expiration date of 12/2014. The NDC number is 0781-5780-92. A total of 692 bottles were distributed nationwide.

Consumers should check their medication for the specific lot number and expiration date listed above. If the medication matches the recalled lot, they should stop using it and contact their healthcare provider or pharmacist for guidance.

The recalled product

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
Manufacturer
Sandoz, Inc
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot DJ2744
  • Exp 12/2014

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Sandoz, Inc

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Same hazard · cross contamination

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