Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-086-02
Reason: Lack of Assurance of Sterility
D-0587-2023May 24, 2023Vadodara, N/A
Apollo Care, LLC
Class IIOngoing
FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-910-25
Reason: Lack of Assurance of Sterility
D-0634-2023May 24, 2023Columbia, MO
Astral SteriTech Private Ltd.
Class IITerminated
Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC66794-216-41
Reason: Lack of Assurance of Sterility
D-0626-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-021-10
Reason: Lack of Assurance of Sterility
D-0590-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-218-41
Reason: Lack of Assurance of Sterility
D-0628-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41
Reason: Lack of Assurance of Sterility
D-0600-2023May 24, 2023Vadodara, N/A
Apollo Care, LLC
Class IIOngoing
VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-255-25
Reason: Lack of Assurance of Sterility
D-0645-2023May 24, 2023Columbia, MO
Astral SteriTech Private Ltd.
Class IITerminated
Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-209-41
Reason: Lack of Assurance of Sterility
D-0607-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30
Reason: Lack of Assurance of Sterility
D-0593-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10
Reason: Lack of Assurance of Sterility
D-0591-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-079-02
Reason: Lack of Assurance of Sterility
D-0630-2023May 24, 2023Vadodara, N/A
Apollo Care, LLC
Class IIOngoing
VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-194-50
Reason: Lack of Assurance of Sterility
D-0641-2023May 24, 2023Columbia, MO
Astral SteriTech Private Ltd.
Class IITerminated
Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-088-01
Reason: Lack of Assurance of Sterility
D-0589-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15
Reason: Lack of Assurance of Sterility
D-0615-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42
Reason: Lack of Assurance of Sterility
D-0612-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-208-15
Reason: Lack of Assurance of Sterility
D-0598-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02
Reason: Lack of Assurance of Sterility
D-0609-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-087-02
Reason: Lack of Assurance of Sterility
D-0588-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-003-31
Reason: Lack of Assurance of Sterility
D-0624-2023May 24, 2023Vadodara, N/A
Apollo Care, LLC
Class IIOngoing
VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-204-50
Reason: Lack of Assurance of Sterility
D-0642-2023May 24, 2023Columbia, MO
Apollo Care, LLC
Class IIOngoing
Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-050-05
Reason: Lack of Assurance of Sterility
D-0635-2023May 24, 2023Columbia, MO
Astral SteriTech Private Ltd.
Class IITerminated
Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-083-01
Reason: Lack of Assurance of Sterility
D-0603-2023May 24, 2023Vadodara, N/A
Apollo Care, LLC
Class IIOngoing
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-264-25
Reason: Lack of Assurance of Sterility
D-0639-2023May 24, 2023Columbia, MO
Astral SteriTech Private Ltd.
Class IITerminated
Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-222-41
Reason: Lack of Assurance of Sterility
D-0582-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-210-41