JB Pharma, USV Pull Allergy Drugs over Quality Issues

JB Chemicals and Pharmaceuticals, along with USV, are conducting a voluntary recall of antihistamine medications in the United States.

According to the latest enforcement report from the US FDA, JB Pharma has initiated two separate recalls involving 23,376 bottles of Cetirizine Hydrochloride Tablets specifically, 9,936 and 13,440 bottles due to the incorrect imprinting of the ID on the medical tablets.

The medication was produced by Unique Pharmaceuticals Labs, a subsidiary of JB Pharma, and was distributed by Rising Pharma Holdings, Inc., based in the United States.

JB Pharma commenced this voluntary action on September 12, categorizing it as a “class III recall,” which indicates that exposure to the product is unlikely to result in adverse health effects, such as death or hospitalization.

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In a separate action, USV is recalling 8,952 bottles of Olopatadine Hydrochloride Ophthalmic Solution due to the detection of an unspecified impurity exceeding the allowable limit.

This voluntary recall, initiated on September 10, is classified as a “class II recall,” suggesting that the products may lead to temporary or medically reversible adverse health effects. Nevertheless, the likelihood of serious adverse health consequences remains low. Cetirizine Hydrochloride is used to alleviate symptoms associated with allergies and related conditions. Olopatadine Hydrochloride serves as a stabilizer in the  medical treatments of conjunctivitis, providing relief from itching, redness, tearing, and swelling.