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- Recall Enforcement Event ID: 74606
Recall Enforment Report D-1510-2016
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by W & C dba The Apothecary, originally initiated on 06-20-2016 for the product Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 The product was recalled due to lack of assurance of sterility: this recall includes of all unexpired lots medications containing calcium gluconate, papaverine, phentolamine, and /or prostaglandin) due to unsubstantiated validation of beyond use dating.. The product was distributed in Mn 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-1510-2016 | 06-20-2016 | 09-28-2016 | Class II | 450 mL | Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. | Terminated |
| D-1511-2016 | 06-20-2016 | 09-28-2016 | Class II | 600 mL | Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. | Terminated |
| D-1509-2016 | 06-20-2016 | 09-28-2016 | Class II | 840 mL | Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. | Terminated |
| D-1508-2016 | 06-20-2016 | 09-28-2016 | Class II | 40,000 mL | Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. | Terminated |
| D-1512-2016 | 06-20-2016 | 09-28-2016 | Class II | 10 mL | Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. | Terminated |
Recall Enforcement Report D-1510-2016
- Event ID
- 74606 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1510-2016 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
- MN 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
- Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
- Reason For Recall
- Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 450 mL 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
- 09-28-2016
- Recall Initiation Date
- 06-20-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 04-19-2017 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
- W & C dba The Apothecary
- Code Info
- LOT #: 06201604@15, 19201602@3, 06201604@8 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-1511-2016
- Event ID
- 74606 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1511-2016 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
- MN 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
- Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
- Reason For Recall
- Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 600 mL 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
- 09-28-2016
- Recall Initiation Date
- 06-20-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 04-19-2017 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
- W & C dba The Apothecary
- Code Info
- LOT #: 06201604@15, 19201602@3, 06201604@8 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-1509-2016
- Event ID
- 74606 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1509-2016 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
- MN 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
- Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
- Reason For Recall
- Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 840 mL 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
- 09-28-2016
- Recall Initiation Date
- 06-20-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 04-19-2017 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
- W & C dba The Apothecary
- Code Info
- LOT #: 12201604@22 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-1508-2016
- Event ID
- 74606 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1508-2016 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
- MN 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
- Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
- Reason For Recall
- Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 40,000 mL 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
- 09-28-2016
- Recall Initiation Date
- 06-20-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 04-19-2017 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
- W & C dba The Apothecary
- Code Info
- LOT #: 12201604@21 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-1512-2016
- Event ID
- 74606 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1512-2016 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
- MN 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
- Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
- Reason For Recall
- Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 10 mL 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
- 09-28-2016
- Recall Initiation Date
- 06-20-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 04-19-2017 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
- W & C dba The Apothecary
- Code Info
- LOT #: 06201604@15, 19201602@3, 06201604@8 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.
