Class II · Moderate risk
Azacitidine for Injection 100mg/Vial
Lack of Sterility Assurance
Azacitidine
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed stability specifications
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62
Affected NDC
43598-0305-62
Compare with the code on your package — it is the most precise check available.
Drug: Azacitidine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Azacitidine NDC 43598-0305 |
100 mg/1 | Injection, Powder, Lyophilized, for Solution Intravenous|subcutaneous |
Dr. Reddy's Laboratories Inc. | Rx |
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- NDC code
- 43598-305-62
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0575-2022 · 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 Azacitidine recalls
See all
Class III · Low risk
Azacitidine for Injection
Subpotent Drug
Class III · Low risk
Azacitidine for Injection 100mg/vial Lyophilized Powder
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Class III · Low risk
Azacitidine
Failed stability specifications
Class II · Moderate risk
Azacitidine for Injection 100 mg/vial For Subcutaneous and…
cGMP deviations: Vials may not be sealed correctly affecting sterility.
Other recalls by Dr. Reddy's Laboratories, Inc.
All 2022 recalls
Class III · Low risk
Varenicline Tablets
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Class II · Moderate risk
Succinylcholine Chloride Injection
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II · Moderate risk
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class I · High risk
Levetiracetam 0.75% in Sodium Chloride Injection 1
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
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