FDA Recall D-0342-2021

Preferred Pharmaceuticals, Inc. · Anaheim, CA

Class II Ongoing 1858 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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,

Lot / code: Lot #: B1121W, Exp.Date: 04/2022

Quantity: Six bottles

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

Recall record

Recall number: D-0342-2021
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: recalled product was distributed to three physicians located CA
Recall initiated: 2021-04-12
Classified by FDA Center: 2021-04-26
FDA published: 2021-05-05
Recalling firm: Preferred Pharmaceuticals, Inc.
Firm location: Anaheim, CA

Drug identification

Brand name(s): CEPHALEXIN
Generic name(s): CEPHALEXIN
Manufacturer(s): Preferred Pharmaceuticals, Inc.
NDC(s): 68788-7529
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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