Amneal Recalls Ranitidine Syrup Due to NDMA Impurity
Amneal Pharmaceuticals is recalling Ranitidine Syrup Oral Solution 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' severity score under the rubric for significant health risks such as impurities.
Plain-English summary
Amneal Pharmaceuticals, Inc. is recalling Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the discovery of the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API).
The affected product was distributed throughout the United States. The recall covers specific lot codes: 06648001A (expiration 11/2019), 06648003A (expiration 4/2020), and 06649001A (expiration 1/2021).
Consumers should check their medication for the NDC number and lot codes listed above. If the product matches the recalled items, they should stop using it and contact their healthcare provider or pharmacist for guidance on alternatives or disposal.
The recalled product
- Product
- Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
- Manufacturer
- Amneal Pharmaceuticals, Inc.
- Category
- Drug — Oral Solution
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
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.
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