The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0852-2020·Announced 2020-02-19

AuroMedics Recalls Amoxicillin and Clavulanate Potassium Tablets Due to Foreign Substance

AuroMedics Pharma LLC is recalling 30,432 bottles of Amoxicillin and Clavulanate Potassium tablets because a customer complaint identified a nylon cable tie as a foreign substance.

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 source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential injury or significant risk, even if specific injury reports are not detailed in the provided text snippet.

Plain-English summary

AuroMedics Pharma LLC is recalling 30,432 bottles of Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles. The product is distributed by Aurobindo Pharma USA, Inc. and was manufactured in India. The specific lot number is SM8719040-A with an expiration date of 02/2021. The National Drug Code (NDC) for the recalled product is 65862-503-20.

The recall was initiated due to a customer complaint identifying a foreign substance, specifically a nylon cable tie, within the product. The agency has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The affected product was distributed nationwide within the United States. Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recalling firm is AuroMedics Pharma LLC.

The recalled product

Product
AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM)
Brand
AMOXICILLIN AND CLAVULANATE POTASSIUM
Manufacturer
AuroMedics Pharma LLC
Category
Drug — Antibiotic
Hazard
Affected units
30,432

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 (2)

  • Lot #: SM8719040-A
  • Exp. Date 02/2021

Distribution

Distributed nationwide across the United States.

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