FDA-Drug2015-05-20Class II
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
Akorn, Inc.
Hazard
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Sold states
Nationwide and Puerto Rico
Affected count
326,666 bottles (16 fl. oz. each)
Manufactured in
1925 W. Field Court, Suite 300, N/A, Lake Forest, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0996-2015Don't want to check this manually?
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