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Class III · Lower riskRecall completed

Rugby

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: AC2106452F, Exp. 3/31/2023
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Distributed by / forRugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152
NDC0536-1242-07
Show the full FDA record
Full product labelRugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionNationwide in the USA
Quantity2,352 boxes
Recall initiated2022-01-04
Report date2022-01-26
Recall completed2023-10-20
Recall numberD-0379-2022
ClassificationClass III
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.