Anvisa Orders Recall of Three Injectable Drug Lots After Contamination and Quality Failures

Overview

• Anvisa published an order in the Diário Oficial da União on Thursday that prohibits sale, distribution and use of three specific injectable lots and requires their recall from the market.
• União Química began a voluntary recall of Polycid lot 2519879 after finding a fragment of glass inside an intact ampoule, a contamination that can injure patients when injected.
• Anvisa suspended Hypofarma’s fosfato de clindamicina lot 24101854 after confirming quality deviations including yellow discoloration, foreign bodies and precipitates inside sealed ampoules.
• Equiplex’s saline solution lot 2513588 was ordered recalled for nonconformity with manufacturing norms, but the agency’s resolution did not specify the exact defect.
• Regulators and journalists expect inspections and follow-up reporting while manufacturers have been contacted for comment and clinicians are warned that contaminated injectables can cause serious bloodstream infections and inflammatory reactions.