Recalls / Class II
Class IID-0342-2021
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,
- Brand name
- Cephalexin
- Generic name
- Cephalexin
- Active ingredient
- Cephalexin
- Route
- Oral
- NDC
- 68788-7529
- FDA application
- ANDA210221
- Affected lot / code info
- Lot #: B1121W, Exp.Date: 04/2022
Why it was 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
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, N/A, Anaheim, California 92807-1801
Distribution
- Quantity
- Six bottles
- Distribution pattern
- recalled product was distributed to three physicians located CA
Timeline
- Recall initiated
- 2021-04-12
- FDA classified
- 2021-04-26
- Posted by FDA
- 2021-05-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0342-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.