Drug Enforcement D-0808-2023

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

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Product Information

Product description
Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. 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
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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-0808-2023
Event ID
91788
Recall initiation date
April 26, 2023
Center classification date
June 1, 2023
Code info
All Lots
More code info
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