Consumers are being advised to check their allergy medicine bottles after the FDA announced a recall of selected cetirizine tablets distributed nationwide.
Could the allergy medicine in your cabinet be included in the latest nationwide recall?
Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals, is voluntarily recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg at the consumer level because of cross-contamination with ranitidine. The affected products were distributed nationwide in the United States by Rising Pharma Holdings.
Cetirizine is an antihistamine commonly used to relieve sneezing, a runny nose, itchy or watery eyes, itching of the nose or throat and hives. It works by blocking histamine, a substance involved in allergic reactions.(1✔ ✔Trusted Source
Cetirizine
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Red Spots Expose the Wrong Medicine
The recall began after a pharmacy technician noticed an unusual appearance while counting tablets for dispensing. Some of the white cetirizine tablets reportedly contained red dots or appeared discoloured because of multiple red marks.
An investigation found that the affected tablets may have been cross-contaminated with ranitidine during manufacturing.The FDA-posted company announcement stated:
“Unique Pharmaceutical Laboratories is voluntarily recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg to the consumer level due to cross contamination with Ranitidine.”
No adverse events associated with the recalled tablets had been reported when the company issued the announcement.(2✔ ✔Trusted Source
Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets USP 5 mg Due to Potential Cross Contamination with Ranitidine
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Why an Unexpected Drug Can Become Dangerous
Cross-contamination occurs when one medicine unintentionally enters another product during manufacturing, processing or packaging. In this case, a person expecting to take an allergy tablet could unknowingly consume ranitidine.
The greatest concern involves consumers who are allergic or hypersensitive to ranitidine or its ingredients. According to the recall notice, exposure could cause a severe allergic reaction or anaphylaxis, which can be life-threatening.
Warning signs may include:
- Difficulty breathing or swallowing
- Swelling of the face or throat
- Sudden swelling beneath the skin
- Itching or hives
- Low blood pressure
- Dizziness or loss of consciousness
Anyone who develops breathing difficulty, severe swelling, fainting or other signs of anaphylaxis should seek emergency medical care immediately.(2✔ ✔Trusted Source
Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets USP 5 mg Due to Potential Cross Contamination with Ranitidine
)
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Check the Bottle Before Your Next Dose
The recall covers 100-count HDPE bottles of Cetirizine Hydrochloride Tablets USP 5 mg.
NDC: 16571-401-10
Distributor: Rising Pharma Holdings Inc.
Expiration date: October 2028
Affected lot numbers:
- GY825029
- GY825030
- GY825031
- GY825032
Consumers should compare the product name, NDC, expiration date and lot number printed on their bottle with the recall information. Those who have an affected bottle should stop using the recalled product and contact their pharmacist, healthcare provider or distributor for return and replacement instructions.
References:
- Cetirizine- (https://medlineplus.gov/druginfo/meds/a623043.html)
- Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets USP 5 mg Due to Potential Cross Contamination with Ranitidine- (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unique-pharmaceutical-laboratories-div-j-b-chemicals-pharmaceuticals-ltd-issues-voluntary-nationwide)
Source-Medindia