FDA-Drug2020-03-18Class II

Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11

American Health Packaging
Hazard

CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Sold states
Nationwide USA
Affected count
53,619 cartons
Manufactured in
2550 John Glenn Ave Ste A, Columbus, OH, United States
Products
Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1003-2020

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