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Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, NDC 68180-405-01

Drug Recall

Official source record

Recall number
D-0390-2021
Event ID
87871
Classification
Class II
Status
Terminated
Recalling company
Lupin Pharmaceuticals Inc.
Reason for recall
Subpotent Drug
Report date
May 26, 2021
Recall initiation date
April 29, 2021
Termination date
February 22, 2022
Distribution pattern
Nationwide within the United States

Drug product identifiers

Manufacturer
Lupin Pharmaceuticals, Inc.
Brand name
CEFIXIME
Generic name
CEFIXIME
Substance name
CEFIXIME
Product NDCs
68180-405; 68180-407; 68180-416; 68180-423
Package NDCs
68180-405-01; 68180-407-03; 68180-407-04; 68180-416-08; 68180-416-11; 68180-423-08; 68180-423-11
Route
ORAL

Where this information comes from

View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

Is this recall still active?

According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this medication?

Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.

Where can I find more official information?

The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.