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.
What this means for you
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.
Related recalls
Same manufacturer · InvaGen Pharmaceuticals, Inc.
See all →- SeverePrescription Vigabatrin Powder Recalled for Defective Container Leakage Risk
FDA (Drugs) · 2024-01-17
- LowInvaGen Recalls Gabapentin Tablets Due to Impurity Test Failure
FDA (Drugs) · 2020-05-27
- ModerateInvaGen Recalls Testosterone Topical Solution Due to Defective Container
FDA (Drugs) · 2019-07-10
- ModerateInvaGen Recalls Testosterone Cypionate Injection Due to Particulate Matter
FDA (Drugs) · 2019-04-24
- ModerateInvaGen Recalls Testosterone Cypionate Injection Due to Particulate Matter
FDA (Drugs) · 2019-04-24
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17