Recalls / Class II
Class IID-0996-2015
Product
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
- Affected lot / code info
- Lot # 618358, Exp. 11/15/2015; Lot # 618646, Exp. 11/18/2015; Lot # 618649, Exp. 11/19/2015; Lot # 618652, Exp. 11/20/2015; Lot # 618746, Exp. 11/26/2015; Lot # 618749, Exp. 11/27/2015; Lot # 618934, Exp. 12/5/2015; Lot # 618940, Exp. 12/6/2015; Lot # 618946, Exp. 12/8/2015; Lot # 621496, Exp. 5/13/2016; Lot # 621890, Exp. 6/24/2016; Lot # 622779, Exp. 7/27/2016; Lot # 623389, Exp. 8/31/2016; Lot # 623829, Exp. 9/27/2016; Lot # 623946, Exp. 10/2/2016; Lot # 623952, Exp. 10/3/2016; Lot # 623955, Exp. 10/3/2016; Lot # 624147, Exp. 10/8/2016; Lot # 624153, Exp. 10/9/2016; Lot # 624159, Exp. 10/15/2016; Lot # 624162, Exp. 10/17/2016; Lot # 624271, Exp. 10/18/2016; Lot # 624274, Exp. 10/18/2016; Lot # 624490, Exp. 10/23/2016; Lot # 624493, Exp. 10/23/2016; Lot # 624496, Exp. 10/25/2016; Lot # 624499, Exp. 10/25/2016; Lot # 624744, Exp. 11/6/2016; Lot # 624747, Exp. 11/6/2016; Lot # 624750, Exp. 11/8/2016; Lot # 624753, Exp. 11/8/2016; Lot # 624836, Exp. 11/14/2016; Lot # 624839, Exp. 11/15/2016; Lot # 625120, Exp. 12/4/2016; Lot # 625123, Exp. 12/29/2016; Lot # 625126, Exp. 12/30/2016; Lot # 625795, Exp. 1/14/2017; Lot # 625918, Exp. 1/22/2017; Lot # 625921, Exp. 1/23/2017; Lot # 625924, Exp. 1/23/2017; Lot # 625927, Exp. 1/24/2017; Lot # 626211, Exp. 2/6/2017; Lot # 626465, Exp. 3/25/2017; Lot # 626735, Exp. 3/5/2017; Lot # 626743, Exp. 3/20/2017
Why it was recalled
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W. Field Court, Suite 300, N/A, Lake Forest, Illinois 60045
Distribution
- Quantity
- 326,666 bottles (16 fl. oz. each)
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-03-17
- FDA classified
- 2015-05-08
- Posted by FDA
- 2015-05-20
- Terminated
- 2017-12-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0996-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.