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.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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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Similar recalls
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