Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
In May 2023 several Injectable products manufactured by Indian Contract Manufacturer Astral SteriTech Pvt. Ltd was recalled by different labels and distribution partners. The affected products were sterile antibiotic powders for injection manufactured between May 2020 and April 2023.The recalled products include Ampicillin, Cephalosporins, Piperacillin & Tazobactam and others.
The products are manufactured for different companies including Piramal Critical Care, Xellia Pharmaceuticals, Meitheal Pharmaceuticals, Civica, Inc. In India Pfizer also announced recall of three anti bacterial injections manufactured by Astral, in India
The recalled is initiated due to concerns of potentially sterility failure of the products. Astral identified the quality concern while investigating out of specification results in environmental monitoring at its manufacturing facility. Intravenous or intramuscular administration of a product for which sterility cannot be assured could result in serious systemic infections and thus is a concern for patient safety.
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