Class II · Moderate risk
Clopidogrel Tablets USP
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Clopidogrel Tablets
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
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
Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16
Affected NDC
54458-0888-16
Compare with the code on your package — it is the most precise check available.
Drug: Clopidogrel
- Recalling firm
- International Laboratories, LLC
- NDC code
- 54458-888-16
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0472-2018 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Clopidogrel recalls
See all
Class II · Moderate risk
Clopidogrel Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Clopidogrel Tablets
Presence of foreign matter
Class II · Moderate risk
Clopidogrel Tablets
Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
Class II · Moderate risk
Clopidogrel Tablets
Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Other recalls by International Laboratories, LLC
All 2018 recalls
Class II · Moderate risk
Pravastatin Sodium Tablets
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Class II · Moderate risk
Pravastatin Sodium Tablets
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Class I · High risk
Pravastatin Sodium Tablets
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.