FDA Drug Class II — Moderate

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

Hazard

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

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Products

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Brand
Amneal Pharmaceuticals, Inc.
UPC
HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021

Units Affected

N/A

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