CLASS III Drug recall · Reported 17 Aug 2022 · FDA Enforcement Report
Azacitidine for Injection 100mg/vial Lyophilized Powder recalled
Teva Pharmaceuticals USA is recalling Azacitidine for Injection 100mg/vial Lyophilized Powder, distributed in Ohio. The recall was initiated on 22 Jul 2022 and the FDA has classified it as Class III.
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-1334-2022
- FDA event ID
- 90594
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Brand
- Azacitidine
- Manufacturer
- BluePoint Laboratories
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Jul 2022
- FDA classified
- 11 Aug 2022
- Reported
- 17 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Jul 2022 | Recall initiated by company | |
| 11 Aug 2022 | Classified by FDA | +20 days |
| 17 Aug 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Where it was distributed
Distributed in Ohio
Questions about this recall
Why was it recalled?
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Which lots are affected?
Lot: FE22001A, Exp 01/2024
Where was it sold?
Distributed in Ohio
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
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| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Azacitidine recalls
All 9| 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, 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 |
| Drug | CLASS II | Azacitidine for Injection 100 mg/vial For Subcutaneous recalled by CIPLA | Cipla | Sterility | Nationwide |