Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68
Reported: June 18, 2025 Initiated: May 23, 2025 #D-0469-2025
Product Description
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68
Reason for Recall
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.
Details
- Recalling Firm
- Ascend Laboratories, LLC
- Units Affected
- 10,620 - 200 mL bottles
- Distribution
- Nationwide in the USA.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68. Recalled by Ascend Laboratories, LLC. Units affected: 10,620 - 200 mL bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 18, 2025. Severity: Moderate. Recall number: D-0469-2025.
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