Lupin Recalls Suprax Cefixime Oral Suspension Due to Discoloration
Lupin Pharmaceuticals is recalling Suprax (cefixime) oral suspension bottles because the product may not meet color specifications after reconstitution.
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 as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the issue is limited to cosmetic discoloration.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling 64,368 bottles of Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles. The affected lots are MSA 2021A, MSA 2024A, and MSA 2025A, with an expiration date of July 2014. The product was distributed nationwide.
The recall was initiated because the product may exhibit discoloration and may not meet specifications for color description once reconstituted. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or Lupin Pharmaceuticals for further instructions or a replacement.
The recalled product
- Product
- Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 64,368
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 (4)
- Lot #s: MSA 2021A
- MSA 2024A
- MSA 2025A
- Exp July 2014
Distribution
Distributed nationwide across the United States.
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