Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Reported: August 17, 2022 Initiated: July 22, 2022 #D-1334-2022
Product Description
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Reason for Recall
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Details
- Recalling Firm
- Teva Pharmaceuticals USA Inc
- Units Affected
- 4162 cartons
- Distribution
- Distributed in Ohio
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56. Recalled by Teva Pharmaceuticals USA Inc. Units affected: 4162 cartons.
Why was this product recalled? ▼
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 17, 2022. Severity: Low. Recall number: D-1334-2022.
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