Reported May 20, 2015 · Terminated
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles…
Akorn, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 1925 W. Field Court, Suite 300 · Lake Forest, IL · 60045
Is this the product you have?
- SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
- Lot codes and dates
45 of 45 products
Products covered by this recall # Product as published 1 Lot # 618358, Exp. 11/15/2015 2 Lot # 618646, Exp. 11/18/2015 3 Lot # 618649, Exp. 11/19/2015 4 Lot # 618652, Exp. 11/20/2015 5 Lot # 618746, Exp. 11/26/2015 6 Lot # 618749, Exp. 11/27/2015 7 Lot # 618934, Exp. 12/5/2015 8 Lot # 618940, Exp. 12/6/2015 9 Lot # 618946, Exp. 12/8/2015 10 Lot # 621496, Exp. 5/13/2016 11 Lot # 621890, Exp. 6/24/2016 12 Lot # 622779, Exp. 7/27/2016 13 Lot # 623389, Exp. 8/31/2016 14 Lot # 623829, Exp. 9/27/2016 15 Lot # 623946, Exp. 10/2/2016 16 Lot # 623952, Exp. 10/3/2016 17 Lot # 623955, Exp. 10/3/2016 18 Lot # 624147, Exp. 10/8/2016 19 Lot # 624153, Exp. 10/9/2016 20 Lot # 624159, Exp. 10/15/2016 - Amount recalled
- 326,666 bottles (16 fl. oz. each)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
This product could cause temporary or reversible health problems — stop using it.
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