D-0272-2021 Class II Terminated
FDA drug recall D-0272-2021 was initiated by Teva Pharmaceuticals USA on February 10, 2021 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable pr… The recall status is terminated (terminated May 15, 2024). Affected quantity: 2,577 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- March 3, 2021
- Initiation Date
- February 10, 2021
- Termination Date
- May 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,577 vials
Product Description
Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Reason for Recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Distribution Pattern
Product was distributed nationwide in the USA and Puerto Rico.
Code Information
Lot # 31326669B, exp. date 03/2021