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Recall Observatory FDA recall evidence

Drug product

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88

D-0468-2025

May 23, 2025

Class II

Product summary

Firm
Ascend Laboratories, LLC
Event
Event 96912
Status
Ongoing
Classification
Class II
Quantity
48,936 - 100 mL bottles
Official record key
drug-enforcement:D-0468-2025

Official wording

Reason: 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.

Code information: 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

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification