D-0736-2021 Class II Terminated

Recalled by Teva Pharmaceuticals USA — Parsippany, NJ

FDA drug recall D-0736-2021 was initiated by Teva Pharmaceuticals USA on July 29, 2021 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated June 4, 2024). Affected quantity: 16,644 vials.

Recall Details

Product Type
Drugs
Report Date
August 25, 2021
Initiation Date
July 29, 2021
Termination Date
June 4, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16,644 vials

Product Description

Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Product was distributed Nationwide, including Puerto Rico.

Code Information

Lot #: 31329150B, exp. date 06/2022