Class II · Moderate risk
Ropinirole 0.5 mg tablets
cGMP Deviations
Ropinirole 2mg tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00
Drug: Ropinirole
- Recalling firm
- RemedyRepack Inc.
- NDC code
- 70518-2750-00
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0499-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ropinirole recalls
See all
Class II · Moderate risk
Ropinirole
cGMP deviations
Class II · Moderate risk
Ropinirole
cGMP deviations
Class II · Moderate risk
rOPINIRole Tablets USP 5 mg* 100-count bottle
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 4 mg* 100-count bottle
CGMP Deviations: recalling drug products following an FDA inspection.
Other recalls by RemedyRepack Inc.
All 2023 recalls
Class II · Moderate risk
Clindamycin HCl Capsule
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class II · Moderate risk
Clindamycin HCl
CGMP Deviations
Class II · Moderate risk
Carvedilol 25 mg Tablet
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
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