D-0342-2021 Class II Ongoing
FDA drug recall D-0342-2021 was initiated by Preferred Pharmaceuticals, Inc. on April 12, 2021 and is designated Class II. 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 o… The recall status is ongoing. Affected quantity: Six bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 5, 2021
- Initiation Date
- April 12, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Six bottles
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
Distribution Pattern
recalled product was distributed to three physicians located CA
Code Information
Lot #: B1121W, Exp.Date: 04/2022