Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Olanzapine Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
Affected NDCs
62756-0553-18
62756-0553-83
62756-0553-88
Compare with the code on your package — it is the most precise check available.
Drug: Olanzapine
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- NDC code
- 62756-553-83
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0700-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Olanzapine recalls
See all
Class II · Moderate risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Olanzapine Orally Disintegrating Tablets
cGMP deviations: Temperature abuse
Class II · Moderate risk
Olanzapine single dose vial Lyophilized
cGMP deviations: Temperature abuse
Class II · Moderate risk
Olanzapine Tablets
cGmp Deviations
Other recalls by Sun Pharmaceutical Industries, Inc.
All 2017 recalls
Unclassified
Nystatin Cream
Failed Stability Specifications
Class II · Moderate risk
Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class II · Moderate risk
Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
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