Lupin Recalls Subpotent Cefixime Oral Suspension Bottles Nationwide
Lupin Pharmaceuticals is voluntarily recalling 3,138 bottles of Cefixime for Oral Suspension because the drug is subpotent. The affected product was distributed nationwide in the United States.
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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury or property damage reports, or in this case, a significant quality defect (subpotent drug) that could lead to treatment failure.
Plain-English summary
Lupin Pharmaceuticals Inc. is voluntarily recalling 3,138 bottles of Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles. The recall was initiated on April 29, 2021, and the product was distributed nationwide within the United States.
The reason for the recall is that the drug is subpotent, meaning it may not contain the full labeled amount of the active ingredient. The specific lot number is F900787 with an expiration date of 4/2021. The product is a prescription-only medication manufactured by Lupin Pharmaceuticals, Inc. in Baltimore, Maryland, and Lupin Limited in Manddeep, India.
Consumers and healthcare providers should check their inventory for the specific NDC 68180-405-01 and lot number F900787. If the product matches these details, it should be returned to the pharmacy or supplier for disposal or credit. The recall status is currently terminated as of February 22, 2022.
The recalled product
- Product
- CEFIXIME (CEFIXIME)
- Brand
- CEFIXIME
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 3,138
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 #: F900787
- Exp. Date 4/2021
UPCs (4)
- 0368180423089
- 0368180407034
- 0368180416081
- 0368180416111
Distribution
Distributed nationwide across the United States.
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