Rising Pharma Cetirizine Allergy Tablets for Ages 6+ Recalled
Four lots of Rising Pharma Cetirizine Hydrochloride Tablets USP 5 mg are recalled because of ranitidine cross-contamination. Cetirizine is a commonly used allergy medicine in children. The label gives dosing directions for ages 6 and older and says to ask a doctor for younger children.
What matters now
- Four lots of Cetirizine Hydrochloride Tablets USP 5 mg are affected.
- The recalled lot numbers are GY825029, GY825030, GY825031, and GY825032.
- The recall follows a complaint involving red dots and discoloration on some tablets.
- Unique Pharmaceuticals notified its distributor, Rising Pharma Holdings Inc.; Rising Pharma notified its distributors and direct customers by email and is arranging the return of all recalled products.
Which cetirizine tablets are recalled?
The recalled product is Cetirizine Hydrochloride Tablets USP 5 mg, distributed by Rising Pharma Holdings Inc. in 100-count HDPE bottles. Affected bottles have NDC 16571-401-10, lot numbers GY825029, GY825030, GY825031, or GY825032, and an expiration date of 10/2028. The product was distributed nationwide to several wholesalers and retailers. Cetirizine is a commonly used allergy medicine in children. This product's label gives dosing directions for adults and children ages 6 and older and says to ask a doctor about use in children under 6.
Why the tablets were recalled
The FDA-posted company announcement says the tablets are being recalled because of cross-contamination with ranitidine. A pharmacy technician identified a discrepancy while counting tablets for dispensing. A product complaint described red dots on tablets and some tablets appearing discolored due to multiple red-colored dots.