Cetrizine recall: Red markings and discoloration expose possible drug mix-up in allergy tablets

An antihistamine distributed nationwide has been recalled due to potential cross contamination with a drug that can cause life-threatening side effects in some consumers.

Four lots of cetirizine hydrochloride tablets in 5 mg packaging were pulled from the market because they may contain ranitidine, according to the U.S. Food and Drug Administration recall notice published on July 20.

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Unique Pharmaceutical Laboratories, which distributes under the brand, Rising Pharma Holdings Inc., initiated the recall after a pharmacy technician identified a "discrepancy" when counting tablets while distributing; specifically, the appearance of a red marking and discoloration on some of the recalled Cetirizine Hydrochloride tablets, the FDA reported.

Cetirizine hydrochloride is an antihistamine used to treat various allergy symptoms, while ranitidine is an H2 blocker used to treat stomach conditions such as acid reflux and ulcers, according to the Mayo Clinic.

Consumers with a "hypersensitivity" to the components in ranitidine could suffer serious side effects, among them difficulty in swallowing, throat and facial edema and potentially a loss of consciousness, the FDA report said.

The Chronicle reached out to Unique Pharmaceutical Laboratories for more information.

The affected lots are in 5 mg packaging with the expiration date of October 2028.  

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