Class II · Moderate risk
Clozapine Tablets USP tablet
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Clozapine Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non-Sterile Products
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel
Affected NDCs
0093-4359-01
0093-4359-05
0093-4359-19
0093-4359-93
Compare with the code on your package — it is the most precise check available.
Drug: Clozapine
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0093-4359-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0705-2017 · 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 Orally Disintegrating Tablets
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Class II · Moderate risk
Clozapine Tablets USP
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
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 Teva Pharmaceuticals USA
All 2017 recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
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.