Recall Enforment Report D-0625-2023

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Astral SteriTech Private Ltd., originally initiated on 05-15-2023 for the product Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51 The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0625-2023	05-15-2023	05-24-2023	Class II	249,080 vials	Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51	Lack of Assurance of Sterility	Terminated
D-0626-2023	05-15-2023	05-24-2023	Class II	112,640 vials	Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC66794-216-41	Lack of Assurance of Sterility	Terminated
D-0583-2023	05-15-2023	05-24-2023	Class II	45,160 vials	Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41	Lack of Assurance of Sterility	Terminated
D-0591-2023	05-15-2023	05-24-2023	Class II	419,680 vials	Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10	Lack of Assurance of Sterility	Terminated
D-0630-2023	05-15-2023	05-24-2023	Class II	936,680 vials	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	Lack of Assurance of Sterility	Terminated
D-0582-2023	05-15-2023	05-24-2023	Class II	89,690 vials	Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-222-41	Lack of Assurance of Sterility	Terminated
D-0608-2023	05-15-2023	05-24-2023	Class II	51,280 vials	Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-210-41	Lack of Assurance of Sterility	Terminated
D-0590-2023	05-15-2023	05-24-2023	Class II	59,040 vials	Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-021-10	Lack of Assurance of Sterility	Terminated
D-0589-2023	05-15-2023	05-24-2023	Class II	7,214 bottles	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	Lack of Assurance of Sterility	Terminated
D-0581-2023	05-15-2023	05-24-2023	Class II	17,350 vials	Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41	Lack of Assurance of Sterility	Terminated
D-0587-2023	05-15-2023	05-24-2023	Class II	80,850 vials	Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-086-02	Lack of Assurance of Sterility	Terminated
D-0624-2023	05-15-2023	05-24-2023	Class II	893,950 vials	Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-003-31	Lack of Assurance of Sterility	Terminated
D-0627-2023	05-15-2023	05-24-2023	Class II	223,590 vials	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	Lack of Assurance of Sterility	Terminated
D-0596-2023	05-15-2023	05-24-2023	Class II	58,770 vials	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	Lack of Assurance of Sterility	Terminated
D-0618-2023	05-15-2023	05-24-2023	Class II	739,750 vials	Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-096-02	Lack of Assurance of Sterility	Terminated
D-0593-2023	05-15-2023	05-24-2023	Class II	1,229,090 vials	Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30	Lack of Assurance of Sterility	Terminated
D-0600-2023	05-15-2023	05-24-2023	Class II	91,860 vials	Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41	Lack of Assurance of Sterility	Terminated
D-0612-2023	05-15-2023	05-24-2023	Class II	65,950 vials	Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42	Lack of Assurance of Sterility	Terminated
D-0595-2023	05-15-2023	05-24-2023	Class II	357,550 vials	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	Lack of Assurance of Sterility	Terminated
D-0605-2023	05-15-2023	05-24-2023	Class II	124,010 vials	Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10	Lack of Assurance of Sterility	Terminated
D-0606-2023	05-15-2023	05-24-2023	Class II	107,320 vials	Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-009-20	Lack of Assurance of Sterility	Terminated
D-0585-2023	05-15-2023	05-24-2023	Class II	53,220 vials	Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-084-02	Lack of Assurance of Sterility	Terminated
D-0628-2023	05-15-2023	05-24-2023	Class II	138,610 vials	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	Lack of Assurance of Sterility	Terminated
D-0604-2023	05-15-2023	05-24-2023	Class II	101,550 vials	Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-057-10	Lack of Assurance of Sterility	Terminated
D-0619-2023	05-15-2023	05-24-2023	Class II	243,825 vials	Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-097-02	Lack of Assurance of Sterility	Terminated
D-0623-2023	05-15-2023	05-24-2023	Class II	110,660 vials	Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-002-31	Lack of Assurance of Sterility	Terminated
D-0609-2023	05-15-2023	05-24-2023	Class II	550,160 vials	Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02	Lack of Assurance of Sterility	Terminated
D-0629-2023	05-15-2023	05-24-2023	Class II	169,520 Vials	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	Lack of Assurance of Sterility	Terminated
D-0607-2023	05-15-2023	05-24-2023	Class II	41,320 vials	Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-209-41	Lack of Assurance of Sterility	Terminated
D-0586-2023	05-15-2023	05-24-2023	Class II	59,530 vials	Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-085-02	Lack of Assurance of Sterility	Terminated
D-0611-2023	05-15-2023	05-24-2023	Class II	66,250 vials	Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-211-42	Lack of Assurance of Sterility	Terminated
D-0603-2023	05-15-2023	05-24-2023	Class II	23,187 bottles	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	Lack of Assurance of Sterility	Terminated
D-0615-2023	05-15-2023	05-24-2023	Class II	9,040 bottles	Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15	Lack of Assurance of Sterility	Terminated
D-0610-2023	05-15-2023	05-24-2023	Class II	964,420 vials	Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-090-02	Lack of Assurance of Sterility	Terminated
D-0631-2023	05-15-2023	05-24-2023	Class II	393,930 vials	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	Lack of Assurance of Sterility	Terminated
D-0620-2023	05-15-2023	05-24-2023	Class II	7,940 bottles	Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01	Lack of Assurance of Sterility	Terminated
D-0613-2023	05-15-2023	05-24-2023	Class II	73,475 vials	Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-213-42	Lack of Assurance of Sterility	Terminated
D-0584-2023	05-15-2023	05-24-2023	Class II	8,925 bottles	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	Lack of Assurance of Sterility	Terminated
D-0592-2023	05-15-2023	05-24-2023	Class II	236,610 vials	Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20	Lack of Assurance of Sterility	Terminated
D-0622-2023	05-15-2023	05-24-2023	Class II	204,860 vials	Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-577-10	Lack of Assurance of Sterility	Terminated
D-0617-2023	05-15-2023	05-24-2023	Class II	66,175 vials	Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-095-02	Lack of Assurance of Sterility	Terminated
D-0588-2023	05-15-2023	05-24-2023	Class II	220,340 vials	Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-087-02	Lack of Assurance of Sterility	Terminated
D-0594-2023	05-15-2023	05-24-2023	Class II	35,087 bottles	Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75	Lack of Assurance of Sterility	Terminated
D-0614-2023	05-15-2023	05-24-2023	Class II	41,500 vials	Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-214-42	Lack of Assurance of Sterility	Terminated
D-0616-2023	05-15-2023	05-24-2023	Class II	66,125 vials	Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-094-02	Lack of Assurance of Sterility	Terminated
D-0599-2023	05-15-2023	05-24-2023	Class II	6,127 bottles	Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-243-15	Lack of Assurance of Sterility	Terminated
D-0598-2023	05-15-2023	05-24-2023	Class II	11,555 bottles	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	Lack of Assurance of Sterility	Terminated
D-0621-2023	05-15-2023	05-24-2023	Class II	1,288,510 vials	Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-576-10	Lack of Assurance of Sterility	Terminated
D-0597-2023	05-15-2023	05-24-2023	Class II	1,001,110 vials	Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-207-41	Lack of Assurance of Sterility	Terminated
D-0580-2023	05-15-2023	05-24-2023	Class II	70,040 vials	Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-220-41	Lack of Assurance of Sterility	Terminated
D-0602-2023	05-15-2023	05-24-2023	Class II	591,160 vials	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	Lack of Assurance of Sterility	Terminated
D-0601-2023	05-15-2023	05-24-2023	Class II	119,340 vials	Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02	Lack of Assurance of Sterility	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
70594-078	Piperacillin Sodium And Tazobactam Sodium	Piperacillin Sodium And Tazobactam Sodium	Injection, Powder, For Solution	Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-079	Piperacillin Sodium And Tazobactam Sodium	Piperacillin Sodium And Tazobactam Sodium	Injection, Powder, For Solution	Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-080	Piperacillin Sodium And Tazobactam Sodium	Piperacillin Sodium And Tazobactam Sodium	Injection, Powder, For Solution	Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-081	Ampicillin And Sulbactam	Ampicillin Sodium And Sulbactam Sodium	Injection, Powder, For Solution	Intramuscular; Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-082	Ampicillin And Sulbactam	Ampicillin Sodium And Sulbactam Sodium	Injection, Powder, For Solution	Intramuscular; Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-083	Ampicillin And Sulbactam	Ampicillin Sodium And Sulbactam Sodium	Injection, Powder, For Solution	Intramuscular; Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-084	Ampicillin	Ampicillin Sodium	Injection, Powder, For Solution	Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-085	Ampicillin	Ampicillin Sodium	Injection, Powder, For Solution	Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-086	Ampicillin	Ampicillin Sodium	Injection, Powder, For Solution	Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-087	Ampicillin	Ampicillin Sodium	Injection, Powder, For Solution	Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-088	Ampicillin	Ampicillin Sodium	Injection, Powder, For Solution	Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-089	Cefepime Hydrochloride	Cefepime Hydrochloride	Injection, Powder, For Solution	Intramuscular; Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-090	Cefepime Hydrochloride	Cefepime Hydrochloride	Injection, Powder, For Solution	Intramuscular; Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-094	Ceftriaxone	Ceftriaxone	Injection, Powder, For Solution	Intramuscular; Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-095	Ceftriaxone	Ceftriaxone	Injection, Powder, For Solution	Intramuscular; Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-096	Ceftriaxone	Ceftriaxone	Injection, Powder, For Solution	Intramuscular; Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-097	Ceftriaxone	Ceftriaxone	Injection, Powder, For Solution	Intramuscular; Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
70594-098	Ceftriaxone	Ceftriaxone	Injection, Powder, For Solution	Intravenous	Xellia Pharmaceuticals Usa Llc	Human Prescription Drug
71288-005	Ampicillin And Sulbactam	Ampicillin Sodium And Sulbactam Sodium	Injection, Powder, For Solution	Intramuscular; Intravenous	Meitheal Pharmaceuticals Inc.	Human Prescription Drug
71288-006	Ampicillin And Sulbactam	Ampicillin Sodium And Sulbactam Sodium	Injection, Powder, For Solution	Intramuscular; Intravenous	Meitheal Pharmaceuticals Inc.	Human Prescription Drug
71288-007	Ampicillin And Sulbactam	Ampicillin Sodium And Sulbactam Sodium	Injection, Powder, For Solution	Intravenous	Meitheal Pharmaceuticals Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0625-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	249,080 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0626-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	112,640 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0583-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	45,160 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0591-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	419,680 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0630-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	936,680 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-078-01; 70594-078-02; 70594-079-01; 70594-079-02; 70594-080-01; 70594-080-02
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0582-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-222-41
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	89,690 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0608-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-210-41
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	51,280 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0590-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	59,040 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0589-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	7,214 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-088-01
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0581-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	17,350 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0587-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-086-02
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	80,850 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-084-01; 70594-084-02; 70594-085-01; 70594-085-02; 70594-086-01; 70594-086-02; 70594-087-01; 70594-087-02
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0624-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	893,950 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0627-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	223,590 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0596-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	58,770 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0618-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-096-02
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	739,750 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-094-01; 70594-094-02; 70594-095-01; 70594-095-02; 70594-096-01; 70594-096-02; 70594-097-01; 70594-097-02
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0593-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1,229,090 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71288-005-21; 71288-005-20; 71288-006-31; 71288-006-30
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0600-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	91,860 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0612-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	65,950 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0595-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	357,550 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0605-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	124,010 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0606-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-009-20
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	107,320 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0585-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-084-02
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	53,220 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-084-01; 70594-084-02; 70594-085-01; 70594-085-02; 70594-086-01; 70594-086-02; 70594-087-01; 70594-087-02
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0628-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	138,610 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0604-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-057-10
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	101,550 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0619-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-097-02
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	243,825 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-094-01; 70594-094-02; 70594-095-01; 70594-095-02; 70594-096-01; 70594-096-02; 70594-097-01; 70594-097-02
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0623-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	110,660 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0609-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	550,160 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-089-01; 70594-089-02; 70594-090-01; 70594-090-02
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0629-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	169,520 Vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-078-01; 70594-078-02; 70594-079-01; 70594-079-02; 70594-080-01; 70594-080-02
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0607-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-209-41
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	41,320 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0586-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-085-02
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	59,530 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-084-01; 70594-084-02; 70594-085-01; 70594-085-02; 70594-086-01; 70594-086-02; 70594-087-01; 70594-087-02
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0611-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-211-42
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	66,250 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0603-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	23,187 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-083-01
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0615-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	9,040 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0610-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	964,420 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-089-01; 70594-089-02; 70594-090-01; 70594-090-02
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0631-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	393,930 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-078-01; 70594-078-02; 70594-079-01; 70594-079-02; 70594-080-01; 70594-080-02
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0620-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	7,940 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-098-01
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0613-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-213-42
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	73,475 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0584-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	8,925 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0592-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	236,610 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71288-005-21; 71288-005-20; 71288-006-31; 71288-006-30
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0622-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-577-10
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	204,860 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0617-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	66,175 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-094-01; 70594-094-02; 70594-095-01; 70594-095-02; 70594-096-01; 70594-096-02; 70594-097-01; 70594-097-02
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0588-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	220,340 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-084-01; 70594-084-02; 70594-085-01; 70594-085-02; 70594-086-01; 70594-086-02; 70594-087-01; 70594-087-02
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0594-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	35,087 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71288-007-75
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0614-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-214-42
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	41,500 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0616-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-094-02
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	66,125 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-094-01; 70594-094-02; 70594-095-01; 70594-095-02; 70594-096-01; 70594-096-02; 70594-097-01; 70594-097-02
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0599-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-243-15
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	6,127 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0598-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	11,555 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0621-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1,288,510 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0597-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-207-41
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1,001,110 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0580-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-220-41
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	70,040 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0602-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	591,160 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-081-01; 70594-081-02; 70594-082-01; 70594-082-02
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	92341 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0601-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	119,340 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-24-2023
Recall Initiation Date	05-15-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-05-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Astral SteriTech Private Ltd.
Code Info	All lots within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	70594-081-01; 70594-081-02; 70594-082-01; 70594-082-02
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.