April 2021 FDA Recall Cephalexin by Preferred Pharmaceuticals, Inc.
D-0342-2021 - Failed Impurities/degradation specifications
This Class II drug recall was voluntarily initiated by Preferred Pharmaceuticals, Inc. on April 12, 2021 for the product Cephalexin. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in recalled product was distributed to three physicians located CA and the recall is currently ongoing.
Recall Number: D-0342-2021
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
04-12-2021
05-05-2021
Six bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Preferred Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
recalled product was distributed to three physicians located CA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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,
Batch or Lot Expiration Information
Lot# : B1121W, Exp.Date: 04/2022
