Astral SteriTech Private Ltd.

FDA Regulatory Profile

Astral SteriTech Private Ltd. appears in FDA public data with 52 recalls, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0594-2023, Class II) was initiated on May 15, 2023.

Summary

Total Recalls
52
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0594-2023Class IIAmpicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for MeiMay 15, 2023
D-0616-2023Class IICeftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USMay 15, 2023
D-0598-2023Class IIAmpicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: PMay 15, 2023
D-0590-2023Class IIAmpicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for: Civica IncMay 15, 2023
D-0580-2023Class IIAmpicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, May 15, 2023
D-0625-2023Class IIPiperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal PharmacMay 15, 2023
D-0582-2023Class IIAmpicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 1May 15, 2023
D-0608-2023Class IICefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PAMay 15, 2023
D-0593-2023Class IIAmpicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal PharmaceuticMay 15, 2023
D-0627-2023Class IIPiperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal CriMay 15, 2023
D-0596-2023Class IIAmpicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical May 15, 2023
D-0624-2023Class IIPiperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for Meitheal PharmMay 15, 2023
D-0613-2023Class IICeftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem,May 15, 2023
D-0622-2023Class IIPiperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: CivicMay 15, 2023
D-0614-2023Class IICeftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care, BethlehemMay 15, 2023
D-0581-2023Class IIAmpicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, May 15, 2023
D-0599-2023Class IIAmpicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: PMay 15, 2023
D-0621-2023Class IIPiperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: CivMay 15, 2023
D-0597-2023Class IIAmpicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical CaMay 15, 2023
D-0589-2023Class IIAmpicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia May 15, 2023