Dr. Reddy's Recalls Olanzapine Tablets Due to Impurity Specification Failure
Dr. Reddy's Laboratories is recalling Olanzapine tablets because an impurity exceeded specification limits during stability testing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Olanzapine tablets, USP, 2.5 mg, packaged in 30-count bottles. The recall involves 5,904 bottles distributed nationwide in the United States. The product is identified by NDC 55111-163-30 and code C500202.
The recall was initiated due to failed impurities and degradation specifications. Specifically, an out-of-specification result was found for Related Substance Compound C (Impurity 6 - N-Oxide) at the 18-month stability station. This indicates that the chemical purity of the drug product did not meet the required standards at that specific time point in its stability profile.
Consumers and healthcare providers with this product should stop using it and contact their pharmacist or Dr. Reddy's Laboratories for instructions on return or disposal. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- OLANZAPINE (OLANZAPINE)
- Brand
- OLANZAPINE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 5,904
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- C500202
Distribution
Distributed nationwide across the United States.
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