Multi-event September 2018 FDA Recall Drug by Pharm D Solutions, Llc

This Multi-event Class II drug recall was voluntarily initiated by Pharm D Solutions, Llc on September 10, 2018 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0154-2019 TERMINATED D-0208-2019 TERMINATED D-0202-2019 TERMINATED D-0209-2019 TERMINATED D-0183-2019 TERMINATED D-0156-2019 TERMINATED D-0211-2019 TERMINATED D-0180-2019 TERMINATED D-0162-2019 TERMINATED D-0165-2019 TERMINATED D-0177-2019 TERMINATED D-0201-2019 TERMINATED D-0157-2019 TERMINATED D-0212-2019 TERMINATED D-0172-2019 TERMINATED D-0145-2019 TERMINATED D-0199-2019 TERMINATED D-0176-2019 TERMINATED D-0188-2019 TERMINATED D-0167-2019 TERMINATED D-0214-2019 TERMINATED D-0139-2019 TERMINATED D-0174-2019 TERMINATED D-0151-2019 TERMINATED D-0173-2019 TERMINATED D-0168-2019 TERMINATED D-0138-2019 TERMINATED D-0159-2019 TERMINATED D-0207-2019 TERMINATED D-0144-2019 TERMINATED D-0137-2019 TERMINATED D-0141-2019 TERMINATED D-0203-2019 TERMINATED D-0200-2019 TERMINATED D-0186-2019 TERMINATED D-0150-2019 TERMINATED D-0194-2019 TERMINATED D-0191-2019 TERMINATED D-0195-2019 TERMINATED D-0206-2019 TERMINATED D-0190-2019 TERMINATED D-0169-2019 TERMINATED D-0185-2019 TERMINATED D-0152-2019 TERMINATED D-0205-2019 TERMINATED D-0213-2019 TERMINATED D-0182-2019 TERMINATED D-0198-2019 TERMINATED D-0160-2019 TERMINATED D-0197-2019 TERMINATED D-0181-2019 TERMINATED D-0153-2019 TERMINATED D-0142-2019 TERMINATED D-0170-2019 TERMINATED D-0193-2019 TERMINATED D-0184-2019 TERMINATED D-0163-2019 TERMINATED D-0196-2019 TERMINATED D-0148-2019 TERMINATED D-0161-2019 TERMINATED D-0155-2019 TERMINATED D-0158-2019 TERMINATED D-0189-2019 TERMINATED D-0166-2019 TERMINATED D-0147-2019 TERMINATED D-0171-2019 TERMINATED D-0136-2019 TERMINATED D-0178-2019 TERMINATED D-0204-2019 TERMINATED D-0164-2019 TERMINATED D-0149-2019 TERMINATED D-0192-2019 TERMINATED D-0143-2019 TERMINATED D-0179-2019 TERMINATED D-0146-2019 TERMINATED D-0140-2019 TERMINATED D-0175-2019 TERMINATED D-0187-2019 TERMINATED D-0210-2019 TERMINATED

Recall Number: D-0154-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
4000 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Glutathione 200 mg/mL Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1504-30

Batch or Lot Expiration Information

Lot# Lot: 08012018:94 Discard by: 1/27/2019

Recall Number: D-0208-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
44 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1339-05

Batch or Lot Expiration Information

Lot# Lot: 03292018:66 Discard by: 9/24/2018; 05312018:81 Discard by: 11/27/2018

Recall Number: D-0202-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
195 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1 mg/175 mcg/1 mg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1369-02

Batch or Lot Expiration Information

Lot# Lot: 05302018:59 Discard by: 11/26/2018; 06132018:44 Discard by: 12/10/2018; 06062018:64 Discard by: 12/3/2018; 07262018:97 Discard by: 11/1/2018; 07052018:23 Discard by: 1/1/2019

Recall Number: D-0209-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
40 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions, Houston, Texas --- NDC 69699-1351-05

Batch or Lot Expiration Information

Lot# Lot: 04262018:08 Discard by: 10/22/2018; 07242018:81 Discard by: 1/20/2019

Recall Number: D-0183-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
250 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin/GHRP-2 9 mg/9 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1715-10

Batch or Lot Expiration Information

Lot# Lot: 03202018:46 Discard by: 9/16/2018; 05012018:56 Discard by: 10/28/2018

Recall Number: D-0156-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
2219 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1707-10

Batch or Lot Expiration Information

Lot# Lot: 04252018:33 Discard by: 10/21/2018; 05082018:39 Discard by: 11/4/2018; 06262018:00 Discard by: 12/23/2018; 07192018:13 Discard by: 1/15/2019; 08012018:46 Discard by: 1/28/2019; 08212018:69 Discard by: 11/30/2018

Recall Number: D-0211-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
12 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Water Sterile for Injection 250 mL IV Pharm D Solutions, Houston, Texas --- NDC 69699-1407-25

Batch or Lot Expiration Information

Lot# Lot: 05222018:12 Discard by: 10/21/2018

Recall Number: D-0180-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
409 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin/GHRP-2 6 mg/6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1727-10

Batch or Lot Expiration Information

Lot# Lot: 05012018:48 Discard by: 10/28/2018; 05242018:32 Discard by: 11/20/2018; 06112018:53 Discard by: 12/8/2018

Recall Number: D-0162-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
2737 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
HCG 4000 Unit Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1704-01

Batch or Lot Expiration Information

Lot# Lot: 03142018:73 Discard by: 3/9/2019; 04122018:64 Discard by: 4/7/2019; 07162018:84 Discard by: 7/11/2019; 06192018:36 Discard by: 6/12/2019; 08062018:28 Discard by: 8/1/2019

Recall Number: D-0165-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
3000 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Levocarnitine 170 mg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1617-10

Batch or Lot Expiration Information

Lot# Lot: 04232018:63 Discard by: 10/20/2018

Recall Number: D-0177-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
25 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
QM-4A Quadmix 5 mL 30 PA-2PH-150A-Atropine 0.4 mg Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1342-05

Batch or Lot Expiration Information

Lot# Lot: 07242018:90 Discard by: 1/20/2019

Recall Number: D-0201-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
430 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1367-02

Batch or Lot Expiration Information

Lot# Lot: 06132018:87 Discard by: 12/10/2018; 05302018:66 Discard by: 11/25/2018; 06122018:54 Discard by: 11/17/2018; 07252018:88 Discard by: 1/21/2019

Recall Number: D-0157-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
3 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50

Batch or Lot Expiration Information

Lot# Lot: 09062018:07 Discard by: 10/6/2018

Recall Number: D-0212-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
184 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Zinc Sulfate 1 mg/mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1418-10

Batch or Lot Expiration Information

Lot# Lot: 06072018:60 Discard by: 12/4/2018

Recall Number: D-0172-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
1900 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Phosphate Buffer Solution 0.05 m Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-0912-20

Batch or Lot Expiration Information

Lot# Lot: 06252018:63 Discard by: 12/22/2018; 07312018:35 Discard by: 1/26/2019

Recall Number: D-0145-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
567 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1428-02

Batch or Lot Expiration Information

Lot# Lots: 07192018:88 Discard by: 10/16/2018

Recall Number: D-0199-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
715 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1365-10

Batch or Lot Expiration Information

Lot# Lot: 03292018:02 Discard by: 9/24/2018; 05302018:54 Discard by: 11/26/2018; 06062018:79 Discard by: 12/3/2018; 06122018:31 Discard by: 11/17/2018; 07252018:44 Discard by: 1/21/2019

Recall Number: D-0176-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
600 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Pyridoxine 100 mg/mL, 30 mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1614-30

Batch or Lot Expiration Information

Lot# Lot: 03132018:47 Discard by: 9/9/2018

Recall Number: D-0188-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
10 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Sterile Water 50 mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1421-50

Batch or Lot Expiration Information

Lot# Lot: 08092018:38 Discard by: 2/5/2018

Recall Number: D-0167-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Magnesium 40 gm/ns 1000 mL IV, Pharm D Solutions, Houston, Texas --- NDC 69699-0904-10

Batch or Lot Expiration Information

Lot# Lot: 05242018:04 Discard by: 8/22/2018

Recall Number: D-0214-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
580 vials and 30000 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1745-30

Batch or Lot Expiration Information

Lot# Lot: 02272018:63/A Discard by: 2/22/2019; 08162018:63/A Discard by: 4/30/2019; 10092017:30 Discard by: 10/1/2018; 02272018:63 Discard by: 2/22/2019; 08162018:63 Discard by: 4/30/2019

Recall Number: D-0139-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
6000 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1611-30

Batch or Lot Expiration Information

Lot# Lot: 06182018:55 Discard by: 12/25/2018

Recall Number: D-0174-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
154 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Prostaglandin E1 40 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1347-05

Batch or Lot Expiration Information

Lot# Lot: 04262018:95 Discard by: 10/22/2018; 03292018:59 Discard by: 9/24/2018; 05312018:66 Discard by: 11/27/2018; 06122018:07 Discard by: 12/9/2018

Recall Number: D-0151-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
70 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Epi-Shugarcaine Kit Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1409-60

Batch or Lot Expiration Information

Lot# 08272018:79 Discard by: 10/1/2018

Recall Number: D-0173-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
193 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Prostaglandin E1 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1623-05

Batch or Lot Expiration Information

Lot# Lot: 04262018:18 Discard by: 10/22/2018; 03292018:66 Discard by: 9/24/2018; 05312018:19 Discard by: 11/27/2018; 07022018:55 Discard by: 12/29/2018; 06122018:51 Discard by: 12/9/2018; 07242018:71 Discard by: 1/20/2019; 08302018:90 Discard by: 2/23/2019

Recall Number: D-0168-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
24500 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 1 mg/mL a) 10 mL Injectable NDC 69699-1501-10; b) 30 mL Injectable NDC 69699-1501-30, Pharm D Solutions, Houston, Texas

Batch or Lot Expiration Information

Lot# Lot: a) 04242018:27 Discard by: 9/15/2018; 04302018:55 Discard by: 10/27/2018; b) 03192018:33 Discard by: 9/15/2018; 05222018:28 Discard by: 11/18/2018

Recall Number: D-0138-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
10000 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Ascorbic Acid 500 mg/mL Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1502-50

Batch or Lot Expiration Information

Lot# Lot: 04252018:91 Discard by: 10/21/2018

Recall Number: D-0159-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
1171 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
HCG 10,000 unit/0.3 gm Mannitol Lyopholized, Pharm D Solutions, Houston, Texas ---- NDC 69699-1711-10

Batch or Lot Expiration Information

Lot# Lot: 04182018:46 Discard by: 10/14/2018; 06072018:65 Discard by: 12/3/2018; 05082018:01 Discard by: 11/4/2018; 07282018:20 Discard by: 1/24/2019

Recall Number: D-0207-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
10 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65 mg/Phentolamine 0.59 mcg per mL Pharm D Solutions, Houston, Texas --- NDC 69699-1366-05

Batch or Lot Expiration Information

Lot# Lot: 07242018:35 Discard by: 8/23/2018

Recall Number: D-0144-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
29 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15; b) (LYO) Powder NDC 69699-1760-15, Pharm D Solutions, Houston, Texas

Batch or Lot Expiration Information

Lot# Lots: a)04032018:49 Discard by: 9/30/2018; 05242018:72 Discard by: 11/20/2018; b) 06192018:08 Discard by: 12/16/2018; 06132018:29 Discard by: 12/10/2018

Recall Number: D-0137-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
7150 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20

Batch or Lot Expiration Information

Lot# Lots: 04112018:83 Discard by: 10/8/2018; 03202018:48 Discard by: 9/16/2018; 04302018:91 Discard by: 10/27/2018

Recall Number: D-0141-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
130 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas --- NDC 69699-1323-05

Batch or Lot Expiration Information

Lot# Lots: 04112018:34 Discard by: 10/7/2018; 08012018:66 Discard by: 1/28/2019; 07262018:34 Discard by: 1/8/2019

Recall Number: D-0203-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
40 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1388-05

Batch or Lot Expiration Information

Lot# Lot: 05312018:12 Discard by: 11/27/2018; 07242018:04 Discard by: 1/20/2019

Recall Number: D-0200-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
815 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1366-02

Batch or Lot Expiration Information

Lot# Lot: 03292018:70 Discard by: 9/25/2018; 05302018:94 Discard by: 11/26/2018; 06072018:67 Discard by: 12/4/2018; 06122018:72 Discard by: 12/9/2018; 07252018:72 Discard by: 1/21/2019

Recall Number: D-0186-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
5000 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Slenderella Compound Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1617-30

Batch or Lot Expiration Information

Lot# Lot: 04202018:59 Discard by: 10/17/2018; 08282018:46 Discard by: 2/1/2019

Recall Number: D-0150-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
2000 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Dexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas --- NDC 69699-1610-30

Batch or Lot Expiration Information

Lot# Lot: 08292018:08 Discard by: 2/23/2019

Recall Number: D-0194-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
9 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1352-05

Batch or Lot Expiration Information

Lot# Lot: 04262018:09 Discard by: 10/22/2018; 07022018:48 Discard by: 12/29/2018

Recall Number: D-0191-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
609 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05, Pharm D Solutions, Houston, Texas

Batch or Lot Expiration Information

Lot# Lot: a) 09062018:87 Discard by: 1/14/2019 b) 04042018:44 Discard by: 10/29/2018; 09022018:04 Discard by: 3/1/2019; 05212018:44 Discard by: 11/17/2018; 06122018:83 Discard by: 12/9/2018; 08132018:86 Discard by: 2/9/2019

Recall Number: D-0195-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
20 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1336-05

Batch or Lot Expiration Information

Lot# Lot: 05312018:22 Discard by: 6/30/2018

Recall Number: D-0206-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
336 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1311-03

Batch or Lot Expiration Information

Lot# Lot: 04102018:12 Discard by: 10/7/2018; 05102018:06 Discard by: 11/6/2018; 05222018:76 Discard by: 11/18/2018; 07022018:35 Discard by: 12/29/2018; 08272018:00 Discard by: 1/14/2019; 08082018:14 Discard by: 2/4/2019

Recall Number: D-0190-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
553 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Powder NDC 69699-1353-10, Pharm D Solutions, Houston, Texas

Batch or Lot Expiration Information

Lot# Lot: a) 04132018:97 Discard by: 10/10/2018; 04032018:25 Discard by: 9/30/2018; b) 04162018:29 Discard by: 10/11/2018; 03282018:80 Discard by: 9/24/2018; 06122018:06 Discard by: 12/9/2018; 08132018:55 Discard by: 2/9/2019

Recall Number: D-0169-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
264 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Oxytocin 30 unit in LR 500 mL 0.06 units/mL IV,Pharm D Solutions, Houston, Texas --- NDC 69699-1203-50

Batch or Lot Expiration Information

Lot# Lot: 03152018:12 Discard by: 6/13/2018; 04182018:08 Discard by: 7/17/2018; 04302018:94 Discard by: 7/29/2018; 03292018:44 Discard by: 6/26/2018; 05212018:95 Discard by: 8/19/2018; 06142018:46 Discard by: 9/12/2018; 05312018:37 Discard by: 8/29/2018; 06282018:80 Discard by: 9/26/2018; 07312018:12 Discard by: 10/29/2018; 07102018:53 Discard by: 10/8/2018; 08222018:18 Discard by: 11/20/2018

Recall Number: D-0185-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
108 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin/GHRP-2/Theanine/Mannitol 15 mg/6 mg/75 mg/300 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1731-10

Batch or Lot Expiration Information

Lot# Lot: 07062018:05 Discard by: 1/2/2019

Recall Number: D-0152-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
945 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Epinepherine 1 mg/1 mL 3 mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-0109-03

Batch or Lot Expiration Information

Lot# Lots: 07272018:17 Discard by: 9/25/2018; 08292018:74 Discard by: 10/28/2018

Recall Number: D-0205-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
343 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1308-03

Batch or Lot Expiration Information

Lot# Lot: 04102018:07 Discard by: 10/7/2018; 05102018:18 Discard by: 11/6/2018; 05222018:64 Discard by: 8/1/2018; 07022018:46 Discard by: 12/29/2018; 08012018:81 Discard by: 1/28/2019; 06202018:97 Discard by: 9/17/2018

Recall Number: D-0213-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
a) 4397, b) 4885 c) 1319, d) 4112 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Testosterone in Grapeseed Oil 200 mg/mL, a) 4 mL, b) 5 mL, c) 10 mL and d) 30 mL Injectable, Pharm D Solutions, Houston, Texas NDC 69699-1702-05

Batch or Lot Expiration Information

Lot# Lot: a) Lot: 01302018:77/A Discard by: 1/25/2019; 09042017:74/B Discard by: 8/30/2018; 04042018:51/A Discard by: 3/31/2019; 05152018:94/A Discard by: 5/9/2019; 07022018:04/A Discard by: 6/27/2019; 07162018:80/B Discard by: 7/11/2019; 08272018:15/B Discard by: 8/22/2019; b) 12052017:13/B, Discard by: 11/30/2018; 09042017:74/A Discard by: 8/30/2018; 03212018:39/B Discard by: 3/17/2019; 01302018:77/B Discard by: 1/25/2019; 06262018:25/A Discard by: 6/21/2019; 05212018:45/A Discard by: 5/16/2019; 05152018:94/B Discard by: 5/9/2019; 07162018:80/A Discard by: 7/11/2019 c) Lot: 09132017:58/A Discard by: 9/7/2018; 03212018:39/P Discard by: 3/16/2019; 05012018:45/A Discard by: 4/26/2019; 05012018:45/P Discard by: 4/26/2019; 06042018:58/A Discard by: 5/30/2019; 05152018:94/C Discard by: 5/9/2019; 07022018:04/B Discard by: 6/27/2019 d) Lot: 01082018:40/B Discard by: 1/3/2019; 09042017:74/C Discard by: 8/30/2018; 09132017:58/B Discard by: 9/7/2018; 01302018:77/C Discard by: 1/25/2019; 03212018:39/C Discard by: 3/16/2019; 04042018:51/B Discard by: 3/30/2019; 06042018:58/B Discard by: 5/30/2019; 05012018:45/B Discard by: 4/26/2019; 06132018:02/B Discard by: 6/3/2019; 05212018:94/B Discard by: 5/9/2019; 05152018:94/D Discard by: 5/9/2019; 07162018:80/C Discard by: 7/11/2019; 08062018:67A Discard by: 8/1/2019; 07022018:04/C Discard by: 6/27/2019; 07242018:04/A Discard by: 7/19/2019; 08272018:15/A Discard by: 8/22/2019

Recall Number: D-0182-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
330 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin/GHRP-2 9 mg-6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1728-10

Batch or Lot Expiration Information

Lot# Lot: 03202018:06 Discard by: 9/16/2018; 06112018:49 Discard by: 12/8/2018

Recall Number: D-0198-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
40 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix AT-6 Papa 30 mg/Phent 4 mg/Atrop. 0.3 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1343-05

Batch or Lot Expiration Information

Lot# Lot: 04262018:90 Discard by: 10/22/2018; 05312018:92 Discard by: 11/27/2018

Recall Number: D-0160-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
881 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1743-12

Batch or Lot Expiration Information

Lot# Lot: 04092018:58 Discard by: 10/6/2018; 06072018:03 Discard by: 12/4/2018; 05292018:86 Discard by: 11/25/2018; 07192018:64 Discard by: 1/15/2019; 08302018:30 Discard by: 2/26/2019

Recall Number: D-0197-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
65 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1330-05

Batch or Lot Expiration Information

Lot# Lot: 08062018:52 Discard by: 10/5/2018; 08012018:08 Discard by: 9/30/2018

Recall Number: D-0181-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
124 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin/GHRP-2 18 mg/6 mg powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1748-10

Batch or Lot Expiration Information

Lot# Lot: 04232018:89 Discard by: 10/15/2018

Recall Number: D-0153-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
1095 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Glutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas ---- NDC 69699-1439-59

Batch or Lot Expiration Information

Lot# Lots: 01402018:93 Discard by: 10/10/2018; 07122018:16 Discard by: 9/10/2018; 08302018:65 Discard by:

Recall Number: D-0142-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
148 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1305-03

Batch or Lot Expiration Information

Lot# Lots: 04112018:37 Discard by: 10/1/2018; 06202018:70 Discard by: 12/16/2018; 08082018:95 Discard by: 2/4/2019

Recall Number: D-0170-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
1139 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Phenol 5% and Glycerin Aqueous Solution 10 mL Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1431-10

Batch or Lot Expiration Information

Lot# Lot: 05082018:59 Discard by: 11/4/2018; 08082018:57 Discard by: 2/4/2019

Recall Number: D-0193-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
20 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1354-03

Batch or Lot Expiration Information

Lot# Lot: 07262018:58 Discard by: 1/21/2019

Recall Number: D-0184-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
420 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin/GHRP-2/GHRP-6 Mannitol 9 mg/9 mg/9 mg/300 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1726-10

Batch or Lot Expiration Information

Lot# Lot: 04232018:46 Discard by: 10/13/2018; 06252018:30 Discard by: 12/22/2018; 07232018:10 Discard by: 1/19/2019; 08302018:07 Discard by: 2/25/2019

Recall Number: D-0163-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
114 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
HCG 50,000 unit/0.3 gm Mannitol Lyophilized Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50

Batch or Lot Expiration Information

Lot# Lot: 04092018:36 Discard by: 10/6/2018; 05292018:93 Discard by: 11/25/2018; 08062018:96 Discard by: 2/2/2019; 07022018:64 Discard by: 7/6/2018

Recall Number: D-0196-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
50 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30 mg/mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1319-10

Batch or Lot Expiration Information

Lot# Lot: 06192018:98 Discard by: 12/16/2018

Recall Number: D-0148-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
6850 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-0914-30

Batch or Lot Expiration Information

Lot# Lots: 07312018:46 Discard by: 1/27/2019; 07262018:97 Discard by: 1/21/2019; 07122018:40 Discard by: 1/8/2019

Recall Number: D-0161-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
765 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10

Batch or Lot Expiration Information

Lot# Lot: 03262018:79 Discard by: 9/22/2018; 08212018:75 Discard by: 2/17/2019

Recall Number: D-0155-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
180 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Glycerin 72% (Lidocaine/Epi 2:1) Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1401-30

Batch or Lot Expiration Information

Lot# Lot: 07312018:13 Discard by: 9/28/2018

Recall Number: D-0158-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
10 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
HCG Reconstitued 6000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1739-06

Batch or Lot Expiration Information

Lot# Lot: 09062018:83 Discard by: 10/6/2018

Recall Number: D-0189-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
3523 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Tilarginine Acetate 50 mg/mL, 10 mL, Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1461-10

Batch or Lot Expiration Information

Lot# Lot: 06212018:28 Discard by: 12/11/2019; 06152018:24 Discard by: 12/12/2018

Recall Number: D-0166-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
896 vials; 64000 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution Compound Injectable NDC 69699-1603-30, Pharm D Solutions, Houston, Texas

Batch or Lot Expiration Information

Lot# Lot: a) 09042018:66/A Discard by: 3/3/2019; 07302018:65 Discard by: 1/26/2019; b) 08132018:75/A Discard by: 2/1/2019; 04172018:16 Discard by: 9/30/2018; 03212018:27 Discard by: 9/17/2018; 04242018:82 Discard by: 10/20/2018; 05142018:72 Discard by: 11/10/2018; 06192018:67 Discard by: 12/18/2018; 08142018:00 Discard by: 2/1/2019; 07302018:64 Discard by: 1/26/2019

Recall Number: D-0147-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
29 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0906-12

Batch or Lot Expiration Information

Lot# Lots: 05072018:46 Discard by: 5/1/2019; 07122018:30 Discard by: 7/7/2019

Recall Number: D-0171-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
630 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1432-10

Batch or Lot Expiration Information

Lot# Lot: 08082018:86 Discard by: 2/4/2019

Recall Number: D-0136-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
486 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- NDC 69699-1424-10

Batch or Lot Expiration Information

Lot# Lots: 07032018:93 Discard by: 01/03/2019; 07032018:27 Discard by: 01/03/2019; 07032018:97 Discard by: 01/03/2019

Recall Number: D-0178-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
517 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Reck Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1459-50

Batch or Lot Expiration Information

Lot# Lot: 03262018:11 Discard by: 4/25/2018; 04102018:38 Discard by: 5/10/2018; 05312018:63 Discard by: 6/30/2018; 05032018:97 Discard by: 6/2/2018; 06082018:24 Discard by: 7/8/2018; 05212018:80 Discard by: 6/20/2018; 07102018:60 Discard by: 8/9/2018; 06202018:44 Discard by: 7/19/2018; 07232018:08 Discard by: 8/22/2018; 07022018:62 Discard by: 8/1/2018; 08292018:95 Discard by: 9/28/2018; 08202018:61 Discard by: 9/19/2018

Recall Number: D-0204-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
59 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1344-05

Batch or Lot Expiration Information

Lot# Lot: 04262018:54 Discard by: 10/23/2018; 03292018:91 Discard by: 9/24/2018; 05312018:10 Discard by: 11/27/2018

Recall Number: D-0164-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
442 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
HCG 6000 unit/0.3 gm Mannitol Lyopholized 6000 IU/vial injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1739-06

Batch or Lot Expiration Information

Lot# Lot: 04092018:14 Discard by: 10/6/2018; 06042018:54 Discard by: 12/1/2018; 05292018:81 Discard by: 11/25/2018

Recall Number: D-0149-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
57 bottles; 2300 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2.5 Inhal Soln. NDC 69699-0908-10; c) Nebulization Solution 2.5% Inhal. Soln NDC 69699-0908-10; d) Nebulization 250 mL 2.5% Inhal Soln NDC 69699-0908-25; e) Oral Spray 2.5% 2.5% Oral Soln NDC 69699-0917-60, Pharm D Solutions, Houston, Texas

Batch or Lot Expiration Information

Lot# Lots: a) 05072018:40 Discard by: 5/2/2019; b) 07262018:44 Discard by: 1/22/2019; c) 07122018:83 Discard by: 7/12/2019; d) 07262018:93 Discard by: 1/22/2019; e) 07262018:81 Discard by: 1/21/2019

Recall Number: D-0192-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
67 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1310-03

Batch or Lot Expiration Information

Lot# Lot: 05072018:35 Discard by: 11/3/2018; 06122018:01 Discard by: 12/9/2018

Recall Number: D-0143-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
115 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1317-03

Batch or Lot Expiration Information

Lot# Lots: 04112018:50 Discard by: 10/7/2018; 08082018:53 Discard by: 2/4/2019

Recall Number: D-0179-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
179 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1759-18

Batch or Lot Expiration Information

Lot# Lot: 07272018:31 Discard by: 1/23/2019

Recall Number: D-0146-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
25 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0907-10

Batch or Lot Expiration Information

Lot# Lots: 05072018:27 Discard by: 5/2/2019; 07122018:11 Discard by 7/7/2019

Recall Number: D-0140-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
285 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Bacteriostatic Water for Injection 10 mL, Pharm D Solutions, Houston, Texas --- NDC 69699-1417-10

Batch or Lot Expiration Information

Lot# Lots: 07182018:12 Discard by: 1/14/2019; 04042018:68 Discard by: 9/30/2018; 05152018:57 Discard by: 11/10/2018; 06202018:17 Discard by: 12/17/2018

Recall Number: D-0175-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
189 milliliters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Prostaglandin E1 80 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1337-05

Batch or Lot Expiration Information

Lot# Lot: 04252018:84 Discard by: 10/22/2018; 03292018:62 Discard by: 9/24/2018; 05312018:52 Discard by: 11/27/2018; 07022018:82 Discard by: 11/17/2018; 06122018:96 Discard by: 12/9/2018; 07242018:22 Discard by: 1/20/2019; 08302018:71 Discard by: 2/23/2019

Recall Number: D-0187-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
12 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
0.9% Sodium Chloride for Injection, 50 mL bags, Pharm D Solutions, Houston, Texas --- NDC 69699-1426-10

Batch or Lot Expiration Information

Lot# Lot: 04192018:13 Discard by: 10/16/2018

Recall Number: D-0210-2019

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-10-2018
Reported
11-07-2018
Quantity
521 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81002
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharm D Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the product.
Vigamox Oph. Solution Pharm D Solutions, Houston, Texas --- NDC 69699-0304-05

Batch or Lot Expiration Information

Lot# Lot: 04192018:22 Discard by: 5/17/2018; 04022018:47 Discard by: 4/23/2018; 05102018:77 Discard by: 6/7/2018; 08022018:63 Discard by: 8/30/2018; 08272018:66 Discard by: 9/24/2018