Class II · Moderate risk
Decitabine for Injection 50mg per vial
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Decitabine for Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed impurities/degradation specifications: Failure to water content and impurity
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
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
Affected NDC
69097-0285-37
Compare with the code on your package — it is the most precise check available.
Drug: Decitabine
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- NDC code
- 69097-285-37
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0698-2018 · 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 Decitabine recalls
See all
Class II · Moderate risk
DECITABINE 40 MG / 100 ml NS IVPB
Lack of Assurance of Sterility
Other recalls by InvaGen Pharmaceuticals, Inc.
All 2018 recalls
Class I · High risk
Vigabatrin for Oral Solution
Defective Container: powder may leak out of the pouch
Class III · Low risk
Gabapentin Tablets USP
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Class III · Low risk
Testosterone Topical Solution 30mg of testosterone per pump…
Defective Container; actuator may improperly function and affect dose delivery.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.
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