Defective Container Prompts Recall
Pharmaceutical company Lupin is recalling over 51,000 bottles of a generic antibiotic, Cefdinir for Oral Suspension (250 mg/5 mL), in the U.S. due to defective containers lacking seal integrity. The U.S. Food and Drug Administration (USFDA) reported the issue in its latest Enforcement Report.
Details of the recall
The affected lot, manufactured at Lupin’s Mandideep plant and marketed by Baltimore-based Lupin Pharmaceuticals, Inc., was voluntarily recalled on May 8. The recall is classified as Class II, indicating that while the product may cause temporary or medically reversible adverse health consequences, the probability of serious consequences is remote.
Impact and significance
Cefdinir for Oral Suspension is used to treat a range of bacterial infections. This recall underscores the importance of container integrity in ensuring drug safety and efficacy.
India, the largest supplier of generic medicines, accounts for about 20% of the global supply, manufacturing 60,000 different generic brands across 60 therapeutic categories. These products are shipped to over 200 countries, with key markets including Japan, Australia, Western Europe, and the U.S.
This incident highlights the rigorous quality standards and regulatory oversight in the pharmaceutical industry, essential for maintaining public health and safety.
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