Reported Aug 17, 2022 · Terminated
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint…
Teva Pharmaceuticals USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA Inc · 400 Interpace Pkwy Bldg A · Parsippany, NJ · 07054-1120
Is this the product you have?
- Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd
- in Romania BySindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
- Lot codes and dates
- Lot
FE22001AExp 01/2024
- Lot
- Amount recalled
- 4162 cartons
Where it was sold
Why it was recalled
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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