NDC 72162-1850
Cephalexin 125 mg per 5 mL for suspension
On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack rebottles it from Ascend Laboratories, LLC's NDC 67877-544.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Amaliya Daman, India | Makes it | No problems foundAug 30, 2019 · 6 inspections |
Repackaging site
- Bryant Ranch Prepack, Burbank, CA, United States · repackages it and relabels it
Recalls
- May 23, 2025 · Class II · Ascend Laboratories, LLC
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Lots: Lot #: 23141828, 23141829, Exp Date: 5/31/2025; 23142342, Exp Date: 6/30/2025; 23142708, Exp Date: 7/31/2025; 23144035, Exp Date: 10/31/2025; 23144270, Exp Date: 11/302025; 24140026, Exp Date: 12/31/2025 - May 23, 2025 · Class II · Ascend Laboratories, LLC
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Lots: Lot #: 23142343, Exp Date: 6/30/2025; 23143526, Exp Date: 9/30/2025; 23144036, Exp Date: 10/31/2025; 23144269, Exp Date: 11/30/2025; Lot 24140027, Exp Date: 12/31/2025; 24144282, Exp Date: 10/31/2026 - Nov 23, 2020 · Class II · Ascend Laboratories LLC
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
Lots: Lot#: a) 19144340, 19144341, Exp AUG 2021; b) 20142226, 20142227, Exp MAY 2022
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
- 125 mg per 5 mL
- Approval
- ANDA ANDA210221
- On the market since
- Mar 28, 2019
- Package NDCs
72162-1850-172162-1850-2- Official label
- DailyMed (National Library of Medicine), updated Mar 7, 2024
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