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
Product summary
- 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
Out of Specification