NDC 63629-9204
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 - May 10, 2024 · Class III · Bryant Ranch Prepack, Inc.
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Lots: Lot:225541, 226866, 227369, 227519, 229845, 231422, 234889, Exp: 03/31/2025 - 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
63629-9204-1- Official label
- DailyMed (National Library of Medicine), updated Jul 26, 2024
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