Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sa...

FDA Drug Recall #D-66458-1 — Class II — October 9, 2013

Recall Summary

Recall Number D-66458-1
Classification Class II — Moderate risk
Date Initiated October 9, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Sandoz, Inc
Location Princeton, NJ
Product Type Drugs
Quantity 692 bottles (90 count)

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

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.

Distribution Pattern

Nationwide

Lot / Code Information

Lot DJ2744, Exp 12/2014

Other Recalls from Sandoz, Inc

Recall # Classification Product Date
D-0753-2022 Class II Orphenadrine Citrate Extended-Release Tablets, ... Mar 21, 2022
D-1259-2020 Class II Infuvite PEDiatric Pharmacy, kit in 1 carton (... Apr 21, 2020
D-0127-2020 Class II Sandoz Ranitidine Hydrochloride Capsules 150mg ... Sep 23, 2019
D-0128-2020 Class II Sandoz Ranitidine Hydrochloride Capsules 150mg ... Sep 23, 2019
D-0129-2020 Class II Sandoz Ranitidine Hydrochloride Capsules 300mg ... Sep 23, 2019

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.