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Recall Observatory FDA recall evidence

Drug product

Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Preferred Pharmaceuticals, Inc., Mfg: Ascend Laboratories, LLC, NDC #: 68788-7529-1,

D-0342-2021

April 12, 2021

Class II

Product summary

Firm
Preferred Pharmaceuticals, Inc.
Event
Event 87719
Status
Ongoing
Classification
Class II
Quantity
Six bottles
Official record key
drug-enforcement:D-0342-2021

Official wording

Reason: Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin

Code information: Lot #: B1121W, Exp.Date: 04/2022

Distribution pattern: recalled product was distributed to three physicians located CA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of Specification