NDC 61919-049
Cephalexin 250 mg per 5 mL for suspension
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-124.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Mandideep, India | Makes it, makes the active ingredient and packages it | Serious problems, FDA actionNov 23, 2022 · 6 inspections, 3 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · relabels it
Recalls
- Jan 9, 2019 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Lots: lot F801282, Expiry June 2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Cephalexin: every company that makes it
- Form
- for suspension
- Strength
- 250 mg per 5 mL
- Approval
- ANDA ANDA065234
- On the market since
- Jan 1, 2014
- Package NDCs
61919-049-32- Official label
- DailyMed (National Library of Medicine), updated Jan 17, 2020
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