AuroMedics Recalls Ranitidine Syrup Due to NDMA Contamination
AuroMedics Pharma LLC is recalling Ranitidine Syrup because N-nitrosodimethylamine (NDMA) has been 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 and involves the detection of NDMA, a potential carcinogen, which meets the criteria for a Severe rating due to the significant health risk associated with the contaminant.
Plain-English summary
AuroMedics Pharma LLC is recalling Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottles. The recall involves 19,320 bottles distributed nationwide. The specific lot codes affected are UI1519001-A, UI1519002-A, UI1519003-A, and UI1519004-A.
The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules, and syrups. The FDA has classified this recall as Class II.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions. The product is distributed by Aurobindo Pharma USA Inc. and made in India.
The recalled product
- Product
- Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 19,320
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)
- UI1519001-A UI1519002-A UI1519003-A UI1519004-A
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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