Class II · Moderate risk
Clopidogrel Tablets USP
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Clopidogrel Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of foreign matter
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutical Ltd., Baddi, Himachal, Pradesh, INDIA NDC 33342-060-15
Affected NDC
33342-0060-15
Compare with the code on your package — it is the most precise check available.
Drug: Clopidogrel
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Clopidogrel NDC 33342-0060 |
BISULFATE 75 mg/1 | Tablet Oral |
Macleods Pharmaceuticals Limited | Rx |
- Recalling firm
- Macleods Pharma Usa Inc
- NDC code
- 33342-060-15
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0787-2021 · 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 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
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.
Class I · High risk
Clopidogrel Tablets
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Other recalls by Macleods Pharma Usa Inc
All 2021 recalls
Class II · Moderate risk
Levothyroxine Sodium Tablets USP 150 mcg
Subpotent Drug
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
Presence of foreign substance: plastic-like substance.
Class III · Low risk
Levofloxacin Tablets
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Class II · Moderate risk
Eszopiclone Tablets
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
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