FDA-Drug2020-01-29Class II
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), 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
467 bottles
Manufactured in
119 Creamery Rd, North Blenheim, NY, United States
Products
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0795-2020Don't want to check this manually?
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