PlainRecalls
FDA Drug Moderate Class II Ongoing

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,

Reported: May 5, 2021 Initiated: April 12, 2021 #D-0342-2021

Product Description

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,

Reason for Recall

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

Details

Units Affected
Six bottles
Distribution
recalled product was distributed to three physicians located CA
Location
Anaheim, CA

Frequently Asked Questions

What product was recalled?
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,. Recalled by Preferred Pharmaceuticals, Inc.. Units affected: Six bottles.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Drug on May 5, 2021. Severity: Moderate. Recall number: D-0342-2021.