Preferred Pharmaceuticals Recalls Fexofenadine HCl Tablets Due to Impurities
Preferred Pharmaceuticals is recalling 79 bottles of Fexofenadine HCl 180 mg tablets because they failed impurities and degradation specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The source text does not report any illnesses or injuries, and the hazard is a failure of specifications rather than a confirmed high-risk pathogen or structural defect, fitting the Moderate criteria for a precautionary or specification-based recall without reported harm.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling 79 bottles of Fexofenadine HCl Tablets, 180 mg, 90-count packages. The product was manufactured by Aurohealth LLC and repackaged by Preferred Pharmaceuticals in Anaheim, California. The recall is due to the product failing impurities and degradation specifications.
The affected product is identified by NDC # 68788-6848-09. The specific lots involved are G0219K and C1419E, both with an expiration date of 3/2021. The product was distributed to one physician in Gainesville, Florida.
Consumers and healthcare providers who have this product should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09
- Manufacturer
- Preferred Pharmaceuticals, Inc
- Category
- Drug — Antihistamine
- 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 (3)
- Lot #: G0219K
- Exp 3/2021
- C1419E
Distribution
Distributed in 1 state:
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