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- Recall Enforcement Event ID: 78678
Recall Enforment Report D-0144-2018
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by SSM Health Care St. Louis DBA SSM St. Clare Health Center, originally initiated on 08-10-2017 for the product Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0104-01 The product was recalled due to lack of sterility assurance: microbial growth detected during a routine simulation of the manufacturing process. no batches of distributed product have been identified as actually containing microorganisms.. The product was distributed in Ssm Health Entities In The State Of Mo Only 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-0144-2018 | 08-10-2017 | 01-03-2018 | Class II | N/A | Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0104-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | Terminated |
| D-0137-2018 | 08-10-2017 | 01-03-2018 | Class II | N/A | Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-0333-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | Terminated |
| D-0145-2018 | 08-10-2017 | 01-03-2018 | Class II | N/A | Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-7536-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | Terminated |
| D-0138-2018 | 08-10-2017 | 01-03-2018 | Class II | N/A | Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | Terminated |
| D-0139-2018 | 08-10-2017 | 01-03-2018 | Class II | N/A | HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | Terminated |
| D-0142-2018 | 08-10-2017 | 01-03-2018 | Class II | N/A | Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, , Fenton, MO --- NDC: 88890-0334-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | Terminated |
| D-0141-2018 | 08-10-2017 | 01-03-2018 | Class II | N/A | Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0329-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | Terminated |
| D-0140-2018 | 08-10-2017 | 01-03-2018 | Class II | N/A | Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88887-6795-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | Terminated |
| D-0136-2018 | 08-10-2017 | 01-03-2018 | Class II | N/A | Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-9010-81 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | Terminated |
| D-0143-2018 | 08-10-2017 | 01-03-2018 | Class II | N/A | Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0903-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | Terminated |
Recall Enforcement Report D-0144-2018
- Event ID
- 78678 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0144-2018 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
- SSM Health entities in the state of MO only 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
- Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0104-01
- Reason For Recall
- Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 01-03-2018
- Recall Initiation Date
- 08-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-22-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail 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
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Code Info
- Lot, exp: 170622-007, 9/20/2017; 170710-007, 10/8/2017 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
- 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.
Recall Enforcement Report D-0137-2018
- Event ID
- 78678 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0137-2018 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
- SSM Health entities in the state of MO only 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
- Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-0333-01
- Reason For Recall
- Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 01-03-2018
- Recall Initiation Date
- 08-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-22-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail 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
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Code Info
- Lot: 170711-005, 10/09/2017 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
- 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.
Recall Enforcement Report D-0145-2018
- Event ID
- 78678 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0145-2018 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
- SSM Health entities in the state of MO only 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
- Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-7536-01
- Reason For Recall
- Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 01-03-2018
- Recall Initiation Date
- 08-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-22-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail 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
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Code Info
- Lot, exp: 170620-005, 9/18/2017; 170626-003, 9/24/2017 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
- 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.
Recall Enforcement Report D-0138-2018
- Event ID
- 78678 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0138-2018 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
- SSM Health entities in the state of MO only 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
- Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01
- Reason For Recall
- Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 01-03-2018
- Recall Initiation Date
- 08-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-22-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail 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
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Code Info
- Lot, exp: 170621-008, 09/19/2017; 170703-002, 10/01/2017; 170711-031, 10/09/2017 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
- 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.
Recall Enforcement Report D-0139-2018
- Event ID
- 78678 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0139-2018 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
- SSM Health entities in the state of MO only 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
- HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01
- Reason For Recall
- Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 01-03-2018
- Recall Initiation Date
- 08-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-22-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail 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
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Code Info
- Lot, exp: 170615-004, 9/13/2017; 170720-009, 10/18/2017 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
- 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.
Recall Enforcement Report D-0142-2018
- Event ID
- 78678 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0142-2018 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
- SSM Health entities in the state of MO only 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
- Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, , Fenton, MO --- NDC: 88890-0334-01
- Reason For Recall
- Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 01-03-2018
- Recall Initiation Date
- 08-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-22-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail 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
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Code Info
- Lot, exp: 170614-007, 9/12/2017; 170628-001, 9/26/2017; 170703-017, 10/1/2017; 170706-009, 10/4/2017; 170719-007, 10/17/2017 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
- 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.
Recall Enforcement Report D-0141-2018
- Event ID
- 78678 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0141-2018 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
- SSM Health entities in the state of MO only 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
- Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0329-01
- Reason For Recall
- Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 01-03-2018
- Recall Initiation Date
- 08-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-22-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail 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
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Code Info
- Lot: 170705-002, 10/03/2017 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
- 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.
Recall Enforcement Report D-0140-2018
- Event ID
- 78678 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0140-2018 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
- SSM Health entities in the state of MO only 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
- Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88887-6795-01
- Reason For Recall
- Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 01-03-2018
- Recall Initiation Date
- 08-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-22-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail 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
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Code Info
- Lot, exp: 170627-012, 9/25/2017; 170629-019, 9/27/2017 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
- 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.
Recall Enforcement Report D-0136-2018
- Event ID
- 78678 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0136-2018 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
- SSM Health entities in the state of MO only 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
- Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-9010-81
- Reason For Recall
- Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 01-03-2018
- Recall Initiation Date
- 08-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-22-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail 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
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Code Info
- Lot: 170614-006, exp 9/12/2017 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
- 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.
Recall Enforcement Report D-0143-2018
- Event ID
- 78678 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0143-2018 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
- SSM Health entities in the state of MO only 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
- Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0903-01
- Reason For Recall
- Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 01-03-2018
- Recall Initiation Date
- 08-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 03-22-2018 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- E-Mail 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
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Code Info
- Lot, exp: 170619-011, 9/17/2017; 170707-007, 10/5/2017; 170713-009, 10/11/2017 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
- 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.
