FDA-Drug2020-01-08Class II
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)
American Health Packaging
Hazard
CGMP Deviations: Presence of NDMA impurity detected in product.
Sold states
Nationwide USA
Affected count
1,692 cases of 40 and 50 cups
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0631-2020Don't want to check this manually?
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