Amneal Pharmaceuticals, Inc.: Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

Is my product affected?

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

• Brand RANITIDINE

Check against the official notice below — it lists the full affected range.

What happened

Amneal Pharmaceuticals, Inc. is recalling Ranitidine Tablets, USP 150 mg in 1000-count bottles due to the presence of N-nitrosodimethylamine (NDMA), an impurity found in the active pharmaceutical ingredient. The affected product was distributed throughout the United States and includes multiple lot codes with expiration dates ranging from March 2020 through April 2021.

The recall notice does not specify a remedy or recommended action for consumers who may have purchased this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Distribution: Product was distributed throughout the United States. Quantity: N/A Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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