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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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.
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