The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0529-2020·Announced 2019-12-04

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.

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 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.

See all 5 products in this recall →

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