Class II · Moderate risk
Azacitidine for Injection 100mg/Vial
Lack of Sterility Assurance
Azacitidine for Injection 100 mg/vial
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01.
Affected NDC
72485-0201-01
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 72485-0201 |
100 mg/1 | Injection, Powder, Lyophilized, for Solution Intravenous|subcutaneous |
Armas Pharmaceuticals Inc. | Rx |
- Recalling firm
- Shilpa Medicare Limited
- NDC code
- 72485-201-01
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0122-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 III · Low risk
Azacitidine
Failed stability specifications
Other recalls by Shilpa Medicare Limited
All 2020 recalls
Class II · Moderate risk
Pemrydi Rtu
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Class II · Moderate risk
Pemrydi Rtu
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Class II · Moderate risk
Docetaxel Injection USP 160 mg/8mL
CGMP Deviations
Class II · Moderate risk
Imatinib Mesylate Tablets 400 mg
CGMP Deviations
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