CLASS II Drug recall · Reported 23 Dec 2020 · FDA Enforcement Report
Azacitidine for Injection 100 mg/vial For Subcutaneous recalled by CIPLA
CIPLA is recalling Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only, distributed nationwide in the US. The recall was initiated on 14 Dec 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0165-2021
- FDA event ID
- 86969
- Recalling firm
- CIPLA, Warren, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Dec 2020
- FDA classified
- 16 Dec 2020
- Reported
- 23 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Dec 2020 | Recall initiated by company | |
| 16 Dec 2020 | Classified by FDA | +2 days |
| 23 Dec 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations: Vials may not be sealed correctly affecting sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40
Where it was distributed
USA Nationwide
Questions about this recall
Is Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only recalled?
Yes. CIPLA recalled Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only on 14 Dec 2020. The recall is Class II and its status is Terminated. Recall number D-0165-2021.
Why was it recalled?
cGMP deviations: Vials may not be sealed correctly affecting sterility.
Which lots are affected?
Lot #: 7S10182A, Ex 9/2021
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from CIPLA
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phytonadione Injectable Emulsion, USP 10mg/mL recalled by CiplaPhytonadione | Cipla | Potency & Assay | Nationwide |
| Drug | CLASS II | Arformoterol Tartrate Inhalation Solution recalled by CIPLAArformoterol Tartrate | CIPLA | Sterility | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension 25mg/, For Inhalation Only recalledBudesonide | CIPLA | Sterility | Nationwide |
| Drug | CLASS II | Difluprednate Ophthalmic Emulsion recalled by CIPLADifluprednate | CIPLA | Sterility | Nationwide |
| Drug | CLASS II | Difluprednate Ophthalmic Emulsion recalled by CIPLA | CIPLA | Sterility | Nationwide |
Other Azacitidine recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azacitidine for Injection 100mg/Vial-Dose Vial recalled | Reliance Life Sciences Private | Sterility | Nationwide |
| Drug | CLASS III | Azacitidine for Injection, 100 mg Lyophilized Powder recalled | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Azacitidine for Injection 100mg/vial Lyophilized Powder recalledAzacitidine | Teva Pharmaceuticals USA | Potency & Assay | OH |
| Drug | CLASS III | Azacitidine, 100mg/vial, One Single-dose Vial recalledAzacitidine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Azacitidine, 1,00mg/Vial, One Single-dose Vial recalledAzacitidine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |