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- Recall Enforcement Event ID: 82941
Recall Enforment Report D-1322-2019
Recall Details
Multi event Drug Recall Enforcement Report Class II done by Pharm D Solutions, LLC was FDA Mandated, originally initiated on 05-23-2019 for the product Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 The product was recalled due to lack of sterility assurance.. 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-1322-2019 | 05-23-2019 | 06-19-2019 | Class II | 716 vials | Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Terminated |
| D-1324-2019 | 05-23-2019 | 06-19-2019 | Class II | 26 vails | Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Terminated |
| D-1326-2019 | 05-23-2019 | 06-19-2019 | Class II | 104 vials | Human Chorionic Gonadotropin 12,000 IU vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Terminated |
| D-1329-2019 | 05-23-2019 | 06-19-2019 | Class II | 50 vials | Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Terminated |
| D-1337-2019 | 05-23-2019 | 06-19-2019 | Class II | 371 vials | Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Terminated |
| D-1338-2019 | 05-23-2019 | 06-19-2019 | Class II | a) 114 vials and b) 566 vials | Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-10 | Lack of Sterility Assurance. | Terminated |
| D-1339-2019 | 05-23-2019 | 06-19-2019 | Class II | 4 vials | Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Terminated |
| D-1325-2019 | 05-23-2019 | 06-19-2019 | Class II | 279 vials | Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Terminated |
| D-1327-2019 | 05-23-2019 | 06-19-2019 | Class II | 11 vials | Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Terminated |
| D-1332-2019 | 05-23-2019 | 06-19-2019 | Class II | 66 vials | Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Terminated |
| D-1334-2019 | 05-23-2019 | 06-19-2019 | Class II | 1 vial | Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Terminated |
| D-1331-2019 | 05-23-2019 | 06-19-2019 | Class II | 6 vials | Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Terminated |
| D-1336-2019 | 05-23-2019 | 06-19-2019 | Class II | 704 vials | Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-30 | Lack of Sterility Assurance. | Terminated |
| D-1328-2019 | 05-23-2019 | 06-19-2019 | Class II | 669 vials | Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg) 10 mL Injectable vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Terminated |
| D-1330-2019 | 05-23-2019 | 06-19-2019 | Class II | 24 vials | Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Terminated |
| D-1335-2019 | 05-23-2019 | 06-19-2019 | Class II | 25 vials | Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Terminated |
| D-1323-2019 | 05-23-2019 | 06-19-2019 | Class II | 4 vials | B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1611-30 | Lack of Sterility Assurance. | Terminated |
| D-1333-2019 | 05-23-2019 | 06-19-2019 | Class II | 100 vials | Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Terminated |
Recall Enforcement Report D-1322-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1322-2019 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
- Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 716 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 11292018:75 Exp. 05/28/2019; 01022019:70 Exp. 07/01/2019; 02042019:04 Exp. 08/03/2019; 03042019:94 Exp. 08/31/2019 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-1324-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1324-2019 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
- Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 26 vails Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 02052019:42 Exp. 08/03/2019 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-1326-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1326-2019 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
- Human Chorionic Gonadotropin 12,000 IU vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 104 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 01232019:86 Exp. 07/22/2019; 04042019:86 Exp. 10/01/2019 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-1329-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1329-2019 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
- Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 50 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 01312019:34 Exp. 07/30/2019 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-1337-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1337-2019 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
- Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 371 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 01312019:02 Exp. 08/16/2019; 02072019:45/A Exp. 11/30/2019 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-1338-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1338-2019 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
- Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-10
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- a) 114 vials and b) 566 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: a) 10242018:70/P, Exp. 08/31/2019; b) 10242018:70/A Exp. 08/31/2019; 02262019:49/A Exp. 11/30/2019 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-1339-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1339-2019 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
- Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 4 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 05022019:90 Exp. 07/13/2019 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-1325-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1325-2019 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
- Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 279 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 01082019:88 Exp. 07/06/2019; 03182019:58 Exp. 09/14/2019 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-1327-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1327-2019 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
- Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 11 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 05022019:50 Exp. 10/29/2019; 05082019:91 Exp. 06/08/2019 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-1332-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1332-2019 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
- Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 66 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 03052019:43 Exp. 08/31/2019; 04042019:15 Exp. 10/01/2019; 04172019:08 Exp. 08/31/2019; 05022019:47 Exp. 10/30/2019; 05082019:78 Exp. 06/04/2019 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-1334-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1334-2019 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
- Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 vial Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 05032019:29 Exp. 11/02/2019 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-1331-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1331-2019 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
- Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 6 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 05082019:92 Exp. 06/04/2019 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-1336-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1336-2019 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
- Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-30
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 704 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 10242018:70/B Exp. 08/31/2019; 10302018:63/A Exp. 08/31/2019 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-1328-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1328-2019 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
- Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg) 10 mL Injectable vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 669 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 02202019:53/A Exp. 08/18/2019; 04012019:67/A, 04022019:47/A Exp. 09/28/2019; 04042019:04/A Exp. 09/30/2019; 04082019:38/A Exp. 10/02/2019; 04302019:49/A Exp. 10/27/2019; 05062019:09 Exp. 11/02/2019 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-1330-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1330-2019 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
- Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 24 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 04162019:48 Exp. 10/13/2019; 04302019:70 Exp. 10/27/2019; 05022019:34 Exp. 10/29/2019 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-1335-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1335-2019 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
- Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 25 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 02182019:79 Exp. 08/17/2019; 04162019:86 Exp. 10/13/2019 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-1323-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1323-2019 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
- B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1611-30
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 4 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 04032019:23 Exp. 06/11/2019 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-1333-2019
- Event ID
- 82941 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-1333-2019 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
- Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Reason For Recall
- Lack of Sterility Assurance. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 100 vials Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- FDA Mandated 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
- 06-19-2019
- Recall Initiation Date
- 05-23-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 02-05-2021 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Press Release 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
- Pharm D Solutions, LLC
- Code Info
- Lot #: 12062018:17 Exp. 06/04/2019 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.
