Class II · Moderate risk
Ropinirole 2mg tablets
cGMP Deviations
Ropinirole hydrochloride tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India
Affected NDC
0378-5504-01
Compare with the code on your package — it is the most precise check available.
Drug: Ropinirole
- Recalling firm
- Mylan Pharmaceuticals Inc.
- NDC code
- 0378-5504-01
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-500-2013 · 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 0.5 mg tablets
cGMP Deviations
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.
Other recalls by Mylan Pharmaceuticals Inc.
All 2013 recalls
Class II · Moderate risk
Carton label: Mycophenolate Mofetil for injection
Failed Dissolution Specifications
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Class II · Moderate risk
Acamprosate Calcium
Failed Dissolution Specifications
Class II · Moderate risk
Mycophenolate Mofetil for Injection USP
Presence of precipitate
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