A pharmaceutical company is voluntarily recalling four lots of a common allergy tablet after a pharmacy technician discovered signs of potential contamination.
Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., announced July 18 it is recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg due to possible cross-contamination with ranitidine. The U.S. Food and Drug Administration published the announcement July 20.
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What triggered the recall
The issue was flagged after a pharmacy technician noticed something unusual while counting tablets before dispensing them. The technician observed red dots on some tablets, with several appearing discolored — a sign, investigators determined, of possible ranitidine contamination.
Cetirizine is a widely used over-the-counter antihistamine. Ranitidine, formerly sold under the brand name Zantac, is used to reduce stomach acid.
Who is at risk
For most people, accidental exposure to ranitidine may not cause serious harm. However, for consumers with a known sensitivity to ranitidine or its ingredients, the risk is significant.
According to the recall announcement, ingesting contaminated tablets could trigger severe hypersensitivity reactions, including anaphylaxis — a potentially life-threatening response that can involve a sudden drop in blood pressure, difficulty breathing, difficulty swallowing, swelling of the throat and face, widespread itching, hives and loss of consciousness.
Unique Pharmaceuticals said it has not received any reports of adverse events related to this recall as of the announcement date.
Which products are affected
The recalled product is packaged in HDPE bottles containing 100 tablets and distributed nationwide to wholesalers and retailers. The National Drug Code (NDC) for the affected product is 16571-401-10, distributed by Rising Pharma Holdings Inc.
The four recalled lot numbers are:
- GY825029 — Expiration: October 2028
- GY825030 — Expiration: October 2028
- GY825031 — Expiration: October 2028
- GY825032 — Expiration: October 2028
Consumers can identify the recalled product by checking the product name, manufacturer details and lot number on the bottle label.
What to do if you have the product
Unique Pharmaceuticals has notified its distributor, Rising Pharma Holdings Inc., which has alerted its distributors and direct customers by email and is arranging for the return of all recalled products.
Consumers with questions about the recall can contact Rising Pharma Holdings Inc. by phone at 1-844-874-7464, Monday through Friday, 8 a.m. to 5 p.m. EST. Inquiries can also be sent by email to pv@risingpharma.com or qa@risingpharma.com.
Anyone who has experienced problems potentially related to this product should contact their physician or healthcare provider promptly.
Adverse reactions or quality concerns can also be reported directly to the FDA’s MedWatch Adverse Event Reporting Program online at www.fda.gov/medwatch/report.htm, by calling 1-800-332-1088, or by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the FDA.