The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1186-2014·Announced 2014-04-09

Lupin Recalls Suprax Cefixime Oral Suspension Due to Impurity Failures

Lupin Pharmaceuticals is recalling 4,038 bottles of Suprax Cefixime for Oral Suspension because the product failed impurity specifications at the 9-month stability station.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which is defined as unlikely to cause adverse health consequences. The issue is a failure in impurity/degradation specifications without reported injuries or illnesses.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling 4,038 bottles of Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted). The affected product is prescription-only and was distributed nationwide. The specific lots involved are F300737 and F300743, both with an expiration date of February 2015.

The recall was initiated because the product did not meet the specification for total impurities at the 9-month stability station. This indicates that the medication failed to meet quality standards regarding degradation over time.

Consumers and healthcare providers should discontinue use of the affected lots and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Antibiotic
Hazard
Affected units
4,038

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 #s: F300737 Exp. February 2015
  • F300743 Exp. February 2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Lupin Pharmaceuticals Inc. 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 2 products in this recall →

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