D-0087-2024 Class II Terminated
FDA drug recall D-0087-2024 was initiated by PAR Sterile Products LLC on November 9, 2021 and is designated Class II. Reason for recall: Crystallization; identified as Buprenorphine free base The recall status is terminated (terminated September 29, 2024).
Recall Details
- Product Type
- Drugs
- Report Date
- November 15, 2023
- Initiation Date
- November 9, 2021
- Termination Date
- September 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05
Reason for Recall
Crystallization; identified as Buprenorphine free base
Distribution Pattern
Nationwide USA
Code Information
Lot No: 343716, Exp. Date: 11/2021; Lot No: 350565, Exp. Date: 07/2022; Lot No: 26921, Exp. Date: 07/2022; Lot No: 36227, Exp. Date: 02/2023