The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1187-2014·Announced 2014-04-09

Lupin Recalls Suprax Cefixime Oral Suspension Due to Impurity Failure

Lupin Pharmaceuticals is recalling specific lots 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard involves impurity specifications at a stability station, which is a quality control issue rather than an acute safety risk like contamination or mislabeling of a common allergen.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling 5,172 bottles of Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted). The affected product is prescription-only and was distributed nationwide. The recall involves specific lots with expiration dates of February 2015: Lot # F300736, Lot # F300740, and Lot # F300741.

The recall was initiated because the product did not meet the specification for total impurities at the 9-month stability station. This indicates a failure in the product's degradation specifications 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. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

Product
Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (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 27437-207-03.
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Antibiotic
Hazard
Affected units
5,172

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 (3)

  • Lot #s: F300736 Exp. February 2015
  • F300740 Exp. February 2015
  • F300741 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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