Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Amaliya Daman, India | Makes it | No problems foundAug 30, 2019 · 6 inspections |
Recalls
- Jan 22, 2021 · Class II · Ascend Laboratories LLC
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Lots: Lot # 19144841, Exp 9/2021; 20141673 Exp 4/2022. - Jan 22, 2021 · Class II · Ascend Laboratories LLC
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Lots: Lot #: 19141869, 19141870, EXP 3/2021; 19142762, EXP 5/2021; 19143826, 19143923,19143941, 19143954 EXP 7/2021 - Dec 17, 2020 · Class II · Ascend Laboratories LLC
Failed Impurity/Degradation Specifications
Lots: 20141674, 20141675, 20141676, 20141677, 20141678, - Dec 17, 2020 · Class II · Ascend Laboratories LLC
Failed Impurity/Degradation Specifications
Lots: 20141680, 20141681, 20141759
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, oral
- Strength
- 250 mg per 5 mL
- Approval
- ANDA ANDA210221
- On the market since
- Mar 28, 2019
- Package NDCs
67877-545-6867877-545-88- Official label
- DailyMed (National Library of Medicine), updated Oct 12, 2026
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