Reported Dec 18, 2019 · Ongoing

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and…

Amneal Pharmaceuticals, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Amneal Pharmaceuticals, Inc. · 50 Horseblock Rd · Brookhaven, NY · 11719-9509

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

Lot codes and dates: 204 of 204 codes
AR172033B
11/2019
AR180024A
12/2019
AR180025A
12/2019
AR180118A
12/2019
AR180119A
12/2019
AR180519A
3/2020
AR180615A
3/2020
AR181795A
11/2020
AR181921B
12/2020
AR190705A
4/2021
AR172029A
11/2019
AR172030A
11/2019
AR180021A
12/2019
AR180022A
12/2019
AR180023A
12/2019
AR180123A
12/2019
AR180144A
1/2020
AR180145A
1/2020
AR180146A
1/2020
AR180147A
1/2020
AR180402A
2/2020
AR180465A
2/2020
AR180466A
2/2020
AR180467A
2/2020
AR180468A
2/2020
AR180613A
3/2020
AR181156A
7/2020
AR181157A
7/2020
AR190418B
2/2021
AR171800A
11/2019
Amount recalled: N/A

The agency filed one notice per product. You are reading one of them; the other 4 are below.

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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