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Astral SteriTech Private Ltd.

FDA Regulatory Profile

Astral SteriTech Private Ltd. has 52 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest recall
D-0594-2023 · Class II · May 15, 2023
Latest inspection
Jun 20, 2023 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls52Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections5Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0594-2023Class IIAmpicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for…May 15, 2023
D-0616-2023Class IICeftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals…May 15, 2023
D-0627-2023Class IIPiperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal…May 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-0620-2023Class IICeftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia…May 15, 2023
D-0622-2023Class IIPiperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for…May 15, 2023
D-0590-2023Class IIAmpicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for: Civica…May 15, 2023
D-0621-2023Class IIPiperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for…May 15, 2023
D-0597-2023Class IIAmpicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical…May 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-0595-2023Class IIAmpicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical…May 15, 2023
D-0605-2023Class IICefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah…May 15, 2023
D-0606-2023Class IICefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL…May 15, 2023
D-0628-2023Class IIPiperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for: Piramal…May 15, 2023
D-0625-2023Class IIPiperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal…May 15, 2023
D-0626-2023Class IIPiperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfg. for: Piramal…May 15, 2023
D-0611-2023Class IICeftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem…May 15, 2023
D-0583-2023Class IIAmpicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA…May 15, 2023
D-0615-2023Class IICeftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care…May 15, 2023
D-0589-2023Class IIAmpicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia…May 15, 2023

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 20, 2023Vadodara, IndiaDrugsOfficial Action Indicated (OAI)3005508230
Apr 3, 2018Vadodara, IndiaDrugsNo Action Indicated (NAI)3005508230
May 11, 2015Vadodara, IndiaDrugsVoluntary Action Indicated (VAI)3005508230
Mar 1, 2012Vadodara, IndiaDrugsNo Action Indicated (NAI)3005508230
Jan 28, 2010Vadodara, IndiaDrugsVoluntary Action Indicated (VAI)3005508230

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3005508230Vadodara, India5Jun 20, 2023

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.