Contamination concerns have prompted a recall of a widely used allergy medicine because the problem could trigger a severe reaction in certain patients.
As USA Today reported, the drug in question is cetirizine hydrochloride, an antihistamine commonly taken for seasonal allergies and hives.
What happened?
On July 18, New Jersey-based Rising Pharma Holdings Inc. announced that four lots of 5-milligram cetirizine hydrochloride tablets packaged in 100-count bottles were being recalled. The voluntary recall noted that Unique Pharmaceutical Laboratories in India manufactured the tablets, which were distributed nationwide in the United States.
The issue is possible cross-contamination with ranitidine, a medicine used for heartburn, acid indigestion, and sour stomach. The problem was noticed after a pharmacy technician counting tablets spotted a red dot on some of them, per the recall notice.
To identify the recalled bottles, check for National Drug Code No. 16571-401-10, an expiration date of 10/2028, and lot numbers GY825029, GY825030, GY825031, and GY825032.
Unique Pharmaceutical Laboratories said it had not received reports of adverse reactions. Even so, the recall notice said people with hypersensitivity to ranitidine could face "serious adverse events."
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Why does it matter?
Rising Pharma said in the voluntary recall that contaminated tablets could trigger anaphylaxis in people who are sensitive to ranitidine.
That reaction can be life-threatening, with symptoms including difficulty swallowing and loss of consciousness.
While this may look like an isolated incident, when paired with some of the more high-profile cases of contamination, it does reveal some shortcomings in the supply chain.
For consumers, it seems like paying attention to the growing number of recalls and instances of contamination has never been more necessary.
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What can I do?
Anyone with cetirizine hydrochloride tablets at home should review the bottle label before taking more. Check the manufacturer and distributor information along with the NDC number, expiration date, and the four recalled lot numbers listed in the notice.
For questions or medical concerns, the recall notice said Rising Pharma Holdings Inc. can be reached Monday through Friday from 8 a.m. to 5 p.m. Eastern at 1-844-874-7464 or by email at pv@risingpharma.com or qa@risingpharma.com.
If you believe the medication caused a reaction, contact a doctor immediately. Consumers also can report side effects or product quality problems through the FDA's MedWatch Adverse Event Reporting program online, by mail, or by fax.
Rising Pharma Holdings Inc. is also working on the return of all of the contaminated products, per the recall.
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