Lannett Recalls Ranitidine Syrup Due to NDMA Impurity
Lannett Company, Inc. is recalling 683,149 bottles of Ranitidine Syrup nationwide because NDMA impurity was detected.
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 FDA classified this as a Class II recall. Under the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly given the presence of a known carcinogenic impurity (NDMA) in a pharmaceutical product.
Plain-English summary
Lannett Company, Inc. is recalling 683,149 bottles of Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL, NDC 54838-550-80. The product is distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. The source text does not specify the concentration of the impurity or report any illnesses or injuries.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternatives. The recall covers specific lot codes listed in the official FDA notice.
The recalled product
- Product
- Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80
- Manufacturer
- Lannett Company, Inc.
- Category
- Drug — Oral Solution
- Affected units
- 683,149
Distribution
Distributed nationwide across the United States.
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