Drug Enforcement D-0087-2024

Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.

Status

Terminated

Classification

Class II

Report Date

November 15, 2023

Termination Date

September 29, 2024

Product Information

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
Product quantity
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Reason for recall
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide USA

Location & Firm

Recalling firm
PAR Sterile Products LLC
Address
870 Parkdale Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0087-2024
Event ID
89016
Recall initiation date
November 9, 2021
Center classification date
November 4, 2023
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
More code info
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