Drug Enforcement D-0780-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Status

Ongoing

Classification

Class II

Report Date

June 7, 2023

Termination Date

—

Product Information

Product description
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Product quantity
N/A
Reason for recall
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA and Puerto Rico

Location & Firm

Recalling firm
Akorn, Inc.
Address
5605 Centerpoint Ct Ste A, N/A

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

Codes & Dates

Recall number
D-0780-2023
Event ID
91788
Recall initiation date
April 26, 2023
Center classification date
June 1, 2023
Code info
All Lots
More code info
—