InvaGen Recalls Decitabine for Injection Due to Impurity Failures
InvaGen Pharmaceuticals is recalling Decitabine for Injection because the product failed water content and impurity specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences. The specific failure of impurity specifications warrants a score of 2 rather than 1.
Plain-English summary
InvaGen Pharmaceuticals, Inc. is recalling Decitabine for Injection, 50mg per vial, NDC 69097-285-37. The recall involves 3,222 vials distributed nationwide in the U.S. The affected lots are GE70493, GE70502, and GE70512, all with an expiration date of 8/2019.
The recall was initiated because the product failed to meet water content and impurity specifications. The agency 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.
Healthcare providers and patients should stop using the affected product and contact InvaGen Pharmaceuticals for further instructions or a replacement.
The recalled product
- Product
- Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37
- Manufacturer
- InvaGen Pharmaceuticals, Inc.
- Category
- Drug — Antineoplastic
- Hazard
- Affected units
- 3,222
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 (4)
- Lot #: GE70493
- GE70502
- GE70512
- Exp 8/2019
Distribution
Distributed nationwide across the United States.
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