NDC 55700-631
Ondansetron Hydrochloride 4 mg tablet, film coated
On the label: Lake Erie Medical DBA Quality Care Products LLC. It's repackaged: Lake Erie Medical DBA Quality Care Products LLC rebottles it from Aurobindo Pharma Limited's NDC 65862-187.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
Repackaging site
- Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC, Location not on file · repackages it and relabels it
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ondansetron: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 4 mg
- Approval
- ANDA ANDA078539
- On the market since
- May 25, 2018
- Package NDCs
55700-631-0655700-631-1055700-631-2055700-631-30- Official label
- DailyMed (National Library of Medicine), updated Dec 18, 2024
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?