Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Zyprexa Intramuscular
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC# 0002-7597-01
Affected NDC
0002-7597-01
Compare with the code on your package — it is the most precise check available.
Drug: Olanzapine
- Recalling firm
- Eli Lilly & Company
- NDC code
- 0002-7597-01
- Origin
- IN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0720-2021 · 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 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 Eli Lilly & Company
All 2021 recalls
Class II · Moderate risk
Sterile Diluent
CGMP Deviations
Class I · High risk
Glucagon Emergency Kit for Low Blood Sugar
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Class II · Moderate risk
Trulicity (dulaglutide)
Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Class III · Low risk
ERBITUX CETUXIMAB Injection
Labeling: Missing label; potential for missing primary container label on the vial.
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