FDA Drug Class II — Moderate

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

Hazard

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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Products

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
Brand
Amneal Pharmaceuticals, Inc.
UPC
HB03718A 3/2020 HB03818A 3/2020 HB03918A 3/2020 HB04018A 3/2020 HC01618A 3/2020 HC14618A 5/2020 HC14718A 5/2020 HC14818A 5/2020 HC14918A 5/2020 HC15018A 5/2020 HK02318A 9/2020 HK02418A 9/2020 HK02518A 9/2020 HK02618A 9/2020 HD03119A 3/2021 HD03219A 3/2021 HE03119A 4/2021 HE03219A 4/2021

Units Affected

N/A

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