Preferred Pharmaceuticals Recalls Cephalexin Due to Unidentified Impurity
Preferred Pharmaceuticals is recalling six bottles of Cephalexin for Oral Suspension because an unidentified impurity was detected during testing.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the presence of an unidentified impurity in a prescription drug.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling six bottles of Cephalexin for Oral Suspension, 250 mg/5mL. The product is a generic version of Keflex, USP, and is repackaged by Preferred Pharmaceuticals, Inc., with Ascend Laboratories, LLC listed as the manufacturer. The specific lot number is B1121W, with an expiration date of 04/2022.
The recall was initiated because the manufacturer detected an out-of-specification result for an individual unidentified impurity during related substance test analysis. This failure in impurities and degradation specifications prompted the repackager to initiate the recall.
The recalled product was distributed to three physicians located in California. Patients who may have received this medication should consult their healthcare provider for further instructions.
The recalled product
- Product
- CEPHALEXIN (CEPHALEXIN)
- Brand
- CEPHALEXIN
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Antibiotic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: B1121W
- Exp.Date: 04/2022
Distribution
Distribution scope not specified by the agency.
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