Cetirizine Hydrochloride Tablets Recalled Due to Cross Contamination with Ranitidine

Plain-English summary

JB Chemicals and Pharmaceuticals Ltd is recalling 34,020 100-count bottles of Cetirizine Hydrochloride Tablets USP 5 mg (NDC 16571-401-10). The affected lots are GY825029, GY825030, GY825031, and GY825032, with expiration date 2028-OCT. The product was distributed nationwide in the USA by Rising Pharma Holdings, Inc.

The recall was initiated after customer complaints about discolored tablets and red dots on the tablets. Testing determined that the discoloration was caused by cross contamination with Ranitidine, another drug product. The FDA has classified this recall as Class I.

Consumers who have a bottle matching the recalled lot numbers and expiration date should verify whether their product is included in the recall and follow the instructions in the FDA recall notice. The recall notice does not describe a specific return or refund process; consumers with questions may contact their pharmacist or healthcare provider.

The recalled product

Product

CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE)

Brand

CETIRIZINE HYDROCHLORIDE

Manufacturer

JB Chemicals and Pharmaceuticals Ltd

Category

Drug — OTC Antihistamine Tablets

Hazard

• cross-contamination
• ranitidine

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

Related recalls