Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-002-31
Reason: Lack of Assurance of Sterility
D-0623-2023May 24, 2023Vadodara, N/A
Apollo Care, LLC
Class IIOngoing
VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-254-25
Reason: Lack of Assurance of Sterility
D-0640-2023May 24, 2023Columbia, MO
Astral SteriTech Private Ltd.
Class IITerminated
Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-095-02
Reason: Lack of Assurance of Sterility
D-0617-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-224-15
Reason: Lack of Assurance of Sterility
D-0584-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-078-02
Reason: Lack of Assurance of Sterility
D-0629-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-009-20
Reason: Lack of Assurance of Sterility
D-0606-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51
Reason: Lack of Assurance of Sterility
D-0625-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-241-41
Reason: Lack of Assurance of Sterility
D-0596-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-217-41
Reason: Lack of Assurance of Sterility
D-0627-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-576-10
Reason: Lack of Assurance of Sterility
D-0621-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-080-02
Reason: Lack of Assurance of Sterility
D-0631-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-057-10
Reason: Lack of Assurance of Sterility
D-0604-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-211-42
Reason: Lack of Assurance of Sterility
D-0611-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-206-41
Reason: Lack of Assurance of Sterility
D-0595-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41
Reason: Lack of Assurance of Sterility
D-0583-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-082-02
Reason: Lack of Assurance of Sterility
D-0602-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10
Reason: Lack of Assurance of Sterility
D-0605-2023May 24, 2023Vadodara, N/A
Apollo Care, LLC
Class IIOngoing
Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-020-05
Reason: Lack of Assurance of Sterility
D-0633-2023May 24, 2023Columbia, MO
Apollo Care, LLC
Class IIOngoing
VANComycin 2.5 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 71170-224-50
Reason: Lack of Assurance of Sterility
D-0643-2023May 24, 2023Columbia, MO
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 71170-284-25
Reason: Lack of Assurance of Sterility
D-0638-2023May 24, 2023Columbia, MO
Apollo Care, LLC
Class IIOngoing
Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-500-25
Reason: Lack of Assurance of Sterility
D-0644-2023May 24, 2023Columbia, MO
Astral SteriTech Private Ltd.
Class IITerminated
Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-090-02
Reason: Lack of Assurance of Sterility
D-0610-2023May 24, 2023Vadodara, N/A
Astral SteriTech Private Ltd.
Class IITerminated
Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-213-42
Reason: Lack of Assurance of Sterility
D-0613-2023May 24, 2023Vadodara, N/A
Apollo Care, LLC
Class IIOngoing
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25
Reason: Lack of Assurance of Sterility
D-0647-2023May 24, 2023Columbia, MO
Apollo Care, LLC
Class IIOngoing
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-550-25