Home / Recalls / Akorn, Inc. / D-0997-2015

D-0997-2015 Class II Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

FDA drug recall D-0997-2015 was initiated by Akorn, Inc. on Mar 17, 2015 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. The recall status is terminated (terminated Dec 27, 2017). Affected quantity: 8,400 unit dose cups (20 mL each).

Recall Details

Product Type: Drugs
Report Date: May 20, 2015
Initiation Date: Mar 17, 2015
Termination Date: Dec 27, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8,400 unit dose cups (20 mL each)

Product Description

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

Reason for Recall

Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot # 624271, Exp. Date 10/2015

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0997-2015
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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