Antihistamine and Decongestant Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablets distributed by Rugby Laboratories due to failed dissolution specifications. Affected lot AC2103329D (Exp 1/2023) was distributed nationwide in 2,184 cartons.
What this means for you
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: This is an FDA Class III recall involving a manufacturing defect (failed dissolution specifications) with no reported illnesses or injuries. The hazard is a potential reduction in drug efficacy rather than direct safety harm, making this a moderate precautionary recall.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Antihistamine & Nasal Decongestant extended-release tablets containing Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, distributed by Rugby Laboratories. The 30-tablet packages (NDC 0638-1242-07) are being recalled because they failed to meet dissolution specifications.
The affected product is lot #AC2103329D with an expiration date of 1/2023. Approximately 2,184 cartons were distributed nationwide.
Consumers who have this product should discontinue use. Patients should consult their healthcare provider about obtaining replacement medication to ensure continued allergy and congestion relief. Healthcare providers and consumers may report adverse events related to this recall to the FDA's MedWatch program.
The recalled product
- Product
- Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Hazard
- dissolution-failure
- reduced-efficacy
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 #: AC2103329D
- Exp 1/2023
Distribution
Distributed nationwide across the United States.
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