Updated
Updated · WSB Atlanta · Jul 21
Rising Pharma Recalls 4 Cetirizine Lots Over Ranitidine Contamination Risk
Updated
Updated · WSB Atlanta · Jul 21

Rising Pharma Recalls 4 Cetirizine Lots Over Ranitidine Contamination Risk

3 articles · Updated · WSB Atlanta · Jul 21

Summary

  • Four lots of 5-mg cetirizine hydrochloride tablets in 100-count bottles were recalled July 18 after possible cross-contamination with ranitidine, an FDA notice said.
  • A pharmacy technician spotted a red dot on some tablets, prompting manufacturer Unique Pharmaceutical Laboratories to alert distributor Rising Pharma, which then notified distributors and customers by email.
  • Nationwide bottles can be identified by NDC 16571-401-10, expiration 10/2028 and lot numbers GY825029, GY825030, GY825031 and GY825032.
  • No adverse reactions have been reported, but patients sensitive to ranitidine could face anaphylaxis, including trouble swallowing, shortness of breath, low blood pressure or loss of consciousness.
  • Consumers are urged to contact physicians over possible symptoms and report problems to FDA MedWatch; Rising Pharma has not said how many bottles were affected.

Insights

Is this allergy pill recall an isolated mistake or a sign of deeper flaws in overseas drug manufacturing?
With lax domestic oversight, how can Indian drugmakers guarantee safety for their exported medicines?