American Health Packaging recalls Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Healt
Recalled January 8, 2020 · FDA recall D-0631-2020 · American Health Packaging
Hazard
CGMP Deviations: Presence of NDMA impurity detected in product. · FDA Class II
Units
1,692 cases of 40 and 50 cups
Sold at
Nationwide USA
Description
CGMP Deviations: Presence of NDMA impurity detected in product.
Product
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
Manufacturer(s)
American Health Packaging
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →