FDA-Drug2019-12-18Class II
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
Preferred Pharmaceuticals, Inc
Hazard
CGMP Deviations: Presence of NDMA impurity detected in product.
Sold states
CA, FL
Affected count
316 bottles
Manufactured in
1250 N Lakeview Ave Ste O, N/A, Anaheim, CA, United States
Products
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0617-2020Don't want to check this manually?
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