Aurobindo Ranitidine Capsules Recalled for NDMA Contamination
AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 300 mg because N-nitrosodimethylamine (NDMA) was detected in the product.
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. According to the rubric, FDA Class II recalls involving significant health risks like NDMA contamination are rated as Severe (4), particularly when no specific injury reports are present to elevate it to Critical.
Plain-English summary
AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 300 mg, 30-count bottles. The recall involves 134,160 bottles distributed nationwide. The product is prescription-only and carries the NDC 59651-145-30.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules, and syrups. The source text does not specify the exact NDMA levels found in these specific capsules or report any illnesses or injuries associated with this lot.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatments. The recall covers specific lot codes ranging from RA3018001-A to RA3019003-A, with expiration dates between July 2020 and May 2021.
The recalled product
- Product
- Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 134,160
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by AuroMedics Pharma LLC 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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