Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied i
Summary
The FDA issued a Class II for Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx by PAR Sterile Products LLC. Reason: Crystallization; identified as Buprenorphine free base.
Details
Source
Drug Recall
External ID
D-0087-2024
Action Date
2023-11-15
Status
Terminated
Category
drug
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
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
Reason for Recall
Crystallization; identified as Buprenorphine free base
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-09
Company
Rochester, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
PAR Sterile Products LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PAR Sterile Products LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PAR Sterile Products LLC have FDA actions?
PAR Sterile Products LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0087-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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