Fexofenadine Hydrochloride Tablets 60 mg Recalled for Failed Impurities and Degradation Specifications
The Harvard Drug Group is recalling Fexofenadine Hydrochloride Tablets, 60 mg, distributed by Major Pharmaceuticals nationwide due to failed impurities and degradation specifications. Affected lots are H00005, H00006, and H00007.
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 FDA classified this as Class II. The source text states only a specifications failure (impurities and degradation) with no reported illnesses or injuries. Under the rubric, Class II recalls without hospitalization reports or injury reports typically score 2 (Moderate).
Plain-English summary
The Harvard Drug Group is recalling Fexofenadine Hydrochloride Tablets, 60 mg, 500 tablets per bottle (NDC 0904-6979-40), distributed by Major Pharmaceuticals. A total of 2,239 bottles have been distributed nationwide. The recall is for failed impurities and degradation specifications.
The affected lots are H00005 (expiration 01/2022), H00006 (expiration 04/2022), and H00007 (expiration 07/2022).
Consumers who have purchased this product should contact their healthcare provider or pharmacist for guidance. Consumers may also contact Major Pharmaceuticals at 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152.
The recalled product
- Product
- Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
- Manufacturer
- The Harvard Drug Group
- Affected units
- 2,239
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 (7)
- Lot
- expiry: Lot H00005
- exp 01/2022
- Lot H00006
- exp 04/2022
- Lot H00007
- exp 07/2022
Distribution
Distributed nationwide across the United States.
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