FDAFDA · Food and drugs·Recall number D-0087-2024
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
Published November 15, 2023 · Recall initiated: November 9, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization; identified as Buprenorphine free base
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUPRENORPHINE HYDROCHLORIDE
- Manufacturer
- PAR Sterile Products LLC
- Distributor
- Nationwide USA
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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