Amneal Recalls Ranitidine Tablets Due to NDMA Impurity
Amneal Pharmaceuticals is recalling Ranitidine Tablets 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the presence of a known carcinogenic impurity (NDMA) in the active ingredient.
Plain-English summary
Amneal Pharmaceuticals, Inc. is recalling Ranitidine Tablets, USP 300 mg in 30-count, 100-count, and 250-count bottles. The recall was initiated because Current Good Manufacturing Practice (CGMP) deviations were identified, specifically the presence of the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API).
The affected products were distributed throughout the United States. The recall covers specific lot codes and expiration dates ranging from November 2019 to March 2021, as detailed in the agency's structured product information.
Consumers should stop using the recalled medication and contact their healthcare provider for guidance on alternative treatments. Patients should not dispose of the medication in a manner that could cause harm to others; they should follow local regulations for disposing of unused prescription drugs.
The recalled product
- Product
- 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).
- Manufacturer
- Amneal Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Amneal Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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