Class II · Moderate risk
Clozapine Orally Disintegrating Tablets
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Clozapine Tablets USP tablet
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
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
Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05
Affected NDC
65862-0846-05
Compare with the code on your package — it is the most precise check available.
Drug: Clozapine
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 |
|---|---|---|---|---|
| Clozapine NDC 65862-0846 |
100 mg/1 | Tablet | Aurobindo Pharma Limited | DRUG FOR FURTHER PROCESSING |
- Recalling firm
- Aurobindo Pharma USA Inc.
- NDC code
- 65862-846-05
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1370-2020 · 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 Clozapine recalls
See all
Class II · Moderate risk
Clozapine Tablets USP
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Class II · Moderate risk
Clozapine Tablets USP
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Clozapine active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Other recalls by Aurobindo Pharma USA Inc.
All 2020 recalls
Class II · Moderate risk
Dicyclomine Hydrochloride Capsules
shortfill; reports of empty capsules.
Class II · Moderate risk
Acetaminophen Tablets
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class II · Moderate risk
Nebivolol Tablets
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Class II · Moderate risk
Cinacalcet Tablets
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
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