WASHINGTON: A recall of cetirizine tablets covers four US lots of the 5 mg allergy medicine after possible cross-contamination with ranitidine, according to a company announcement posted by the Food and Drug Administration.
Unique Pharmaceutical Laboratories initiated the voluntary consumer-level recall on July 18. The FDA published the announcement on July 20 and said the action was conducted with the agency’s knowledge.
The recall applies to Cetirizine Hydrochloride Tablets USP 5 mg in 100-tablet bottles bearing NDC 16571-401-10. The affected lot numbers are GY825029, GY825030, GY825031 and GY825032, all with an October 2028 expiration date. Rising Pharma Holdings distributed the product nationwide to wholesalers and retailers.
The company opened an investigation after a pharmacy technician noticed red dots and discolouration while counting tablets for dispensing. Unique Pharmaceutical Laboratories said it had received no reports of adverse events linked to the recalled product as of the announcement date.
The recall notice said people with hypersensitivity to ranitidine ingredients could face severe allergic reactions after taking contaminated tablets. Possible symptoms include low blood pressure, breathing or swallowing difficulties, facial or throat swelling, hives, itching and loss of consciousness.
Read: Capsule Cheston Recalled in Punjab Over Undeclared Steroid
Rising Pharma is arranging the return of recalled bottles. Consumers may contact the company at 1-844-874-7464 from 8 a.m. to 5 p.m. Eastern Time, Monday through Friday, or email pv@risingpharma.com or qa@risingpharma.com. Anyone experiencing a related health problem should contact a healthcare professional and may submit a report through the FDA MedWatch programme.
