FDA-Drug2020-01-29Class II
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.
Denton Pharma, Inc.
Hazard
CGMP Deviations: Presence of NDMA impurity detected in product.
Sold states
Nationwide
Affected count
1,341 bottles
Manufactured in
119 Creamery Rd, North Blenheim, NY, United States
Products
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0794-2020Don't want to check this manually?
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