Aurobindo Ranitidine Capsules Recalled for NDMA Contamination
AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 potential health risks.
Plain-English summary
AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 150 mg, 60-count bottles, which are distributed by Aurobindo Pharma USA, Inc. The recall involves 45,456 bottles of the prescription-only medication. The product is identified by NDC 59651-144-60 and includes specific lot codes with expiration dates ranging from July 2020 to May 2021.
The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of N-nitrosodimethylamine (NDMA) in the ranitidine capsules. NDMA is a substance that has been detected in various forms of ranitidine, including tablets, capsules, and syrups.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled capsules and contact their healthcare provider or pharmacist for guidance on alternative treatments or replacements.
The recalled product
- Product
- Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 45,456
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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