Amneal Pharmaceuticals, Inc.: Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

Is my product affected?

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

• Brand RANITIDINE

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

What happened

Amneal Pharmaceuticals is recalling Ranitidine Tablets, USP 300 mg in 250-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 February 2020 through January 2021, identified by their specific lot numbers beginning with HB, HF, HK, and HL.

The recall was initiated because of current Good Manufacturing Practice (CGMP) deviations related to the detection of this impurity. The source document does not specify a remedy or instructions for what consumers should do with affected 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: 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

Source

Official record: FDA (Drug enforcement) ↗

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

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