FDA Recall D-0807-2023

Akorn, Inc. · Gurnee, IL

Class II Ongoing 1114 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bottles and c) 100 unit dose cups, Rx Only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Lot / code: All Lots

Quantity: N/A

Reason for recall

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

Recall record

Recall number: D-0807-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA and Puerto Rico
Recall initiated: 2023-04-26
Classified by FDA Center: 2023-06-01
FDA published: 2023-06-07
Recalling firm: Akorn, Inc.
Firm location: Gurnee, IL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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