Class II
Terminated
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
This recall has been terminated (originally issued November 15, 2023).
- Company
- Par Sterile Products Llc
- Recall Initiated
- November 9, 2021
- Posted
- November 15, 2023
- Recall Number
- D-0087-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Rochester, MI, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
Distribution
Nationwide USA
Lot / Code Info
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
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