A pharmaceutical company is voluntarily recalling four lots of a common allergy tablet after a pharmacy technician discovered signs of potential contamination.<\/p>\n
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.<\/p>\n
What triggered the recall<\/p>\n
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 \u2014 a sign, investigators determined, of possible ranitidine contamination.<\/p>\n
Cetirizine is a widely used over-the-counter antihistamine. Ranitidine, formerly sold under the brand name Zantac, is used to reduce stomach acid.<\/p>\n
Who is at risk<\/p>\n
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.<\/p>\n
According to the recall announcement, ingesting contaminated tablets could trigger severe hypersensitivity reactions, including anaphylaxis \u2014 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.<\/p>\n
Unique Pharmaceuticals said it has not received any reports of adverse events related to this recall as of the announcement date.<\/p>\n
Which products are affected<\/p>\n
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.<\/p>\n
The four recalled lot numbers are:<\/p>\n
GY825029<\/b>\u00a0\u2014 Expiration: October 2028<\/p>\n<\/li>\n GY825030<\/b>\u00a0\u2014 Expiration: October 2028<\/p>\n<\/li>\n GY825031<\/b>\u00a0\u2014 Expiration: October 2028<\/p>\n<\/li>\n GY825032<\/b>\u00a0\u2014 Expiration: October 2028<\/p>\n<\/li>\n<\/ul>\n Consumers can identify the recalled product by checking the product name, manufacturer details and lot number on the bottle label.<\/p>\n What to do if you have the product<\/p>\n 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.<\/p>\n 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<\/a> or qa@risingpharma.com<\/a>.<\/p>\n Anyone who has experienced problems potentially related to this product should contact their physician or healthcare provider promptly.<\/p>\n