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Drug FDA Class II Terminated Failed specifications

Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03

Lupin Pharmaceuticals Inc. Published Jun 26, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Lupin Pharmaceuticals Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Content Uniformity Specifications

Hazards

Failed Content Uniformity · primary

Affected products (1)

Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03

CEFIXIME · 3,552 bottles

NDC: 68180-405, 68180-407, 68180-416, 68180-423, 68180-405-01, 68180-407-03, 68180-407-04, 68180-416-08, 68180-416-11, 68180-423-11, 68180-423-08
Lot codes: F201519
Code info: Lot F201519, Expiry: November 2024

Affected areas

Nationwide

Timeline

  1. Initiated
    May 30, 2024
  2. Published
    Jun 26, 2024
  3. Terminated
    Apr 29, 2025
Recall number
D-0559-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.