Multi-event March 2018 FDA Recall Drug by Partell Specialty Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Partell Specialty Pharmacy on March 22, 2018 for the product Drug. The FDA reported the reason for recall as lack of assurance sterility. The product was distributed in NV only and the recall is currently terminated.

Reported Recall Events

D-0657-2018 TERMINATED D-0681-2018 TERMINATED D-0672-2018 TERMINATED D-0677-2018 TERMINATED D-0643-2018 TERMINATED D-0655-2018 TERMINATED D-0647-2018 TERMINATED D-0646-2018 TERMINATED D-0676-2018 TERMINATED D-0668-2018 TERMINATED D-0680-2018 TERMINATED D-0667-2018 TERMINATED D-0654-2018 TERMINATED D-0652-2018 TERMINATED D-0637-2018 TERMINATED D-0635-2018 TERMINATED D-0671-2018 TERMINATED D-0650-2018 TERMINATED D-0642-2018 TERMINATED D-0658-2018 TERMINATED D-0664-2018 TERMINATED D-0663-2018 TERMINATED D-0641-2018 TERMINATED D-0644-2018 TERMINATED D-0634-2018 TERMINATED D-0679-2018 TERMINATED D-0674-2018 TERMINATED D-0670-2018 TERMINATED D-0659-2018 TERMINATED D-0649-2018 TERMINATED D-0640-2018 TERMINATED D-0636-2018 TERMINATED D-0665-2018 TERMINATED D-0651-2018 TERMINATED D-0639-2018 TERMINATED D-0662-2018 TERMINATED D-0673-2018 TERMINATED D-0678-2018 TERMINATED D-0661-2018 TERMINATED D-0656-2018 TERMINATED D-0675-2018 TERMINATED D-0682-2018 TERMINATED D-0660-2018 TERMINATED D-0669-2018 TERMINATED D-0638-2018 TERMINATED D-0653-2018 TERMINATED D-0666-2018 TERMINATED D-0648-2018 TERMINATED D-0645-2018 TERMINATED

Recall Number: D-0657-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone Propionate 100mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20171228@15, BUD 03/28/2018

Recall Number: D-0681-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Estradiol 55 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

Batch or Lot Expiration Information

Lot# : 20180104@73, BUD 07/03/2018.

Recall Number: D-0672-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone/Anastrozole 60 mg/4 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

Batch or Lot Expiration Information

Lot# : 20171122@65, BUD 05/21/2018; 20171115@56, BUD 05/14/2018; 20171002@77, BUD 03/31/2018; 20171006@63, BUD 04/04/2018; 20171009@55, BUD 04/07/2018; 20171117@72, BUD 05/16/2018.

Recall Number: D-0677-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Estradiol 25 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

Batch or Lot Expiration Information

Lot# : 20171204@15, BUD 06/02/2018; 20171006@57, BUD 04/04/2018; 20171018@62, BUD 04/16/2018; 20180116@24, BUD 07/15/2018.

Recall Number: D-0643-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Nandrolone decanoate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180221@15, BUD 05/22/2018, 20180123@10, BUD 04/23/2018.

Recall Number: D-0655-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 12.5 mg/mL, Injectable Liquid, packaged in a) 5 mL amber vial, and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : a) 20180119@4, 20171016@10, 20171106@5, 20171214@55, 20180207@5 BUD 04/14/2018; 20180212@15, BUD 03/29/2018; 20180117@26, BUD 07/16/2018. b) 20180219@17, BUD 08/18/2018; 20180205@1, 20180102@39, 20180124@3, BUD 04/14/2018; 20180221@23, BUD 08/20/2018.

Recall Number: D-0647-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180123@4, BUD 4/14/2018.

Recall Number: D-0646-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Vitamin D 50,000 unit/ml, 5 mL amber vial, Injectable Liquid, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. # 101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180220@4, BUD 03/22/2018, 20180221@14, BUD 03/23/2018, 20180228@1, BUD 03/30/2018.

Recall Number: D-0676-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Estradiol 20 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

Batch or Lot Expiration Information

Lot# : 20180129@15, BUD 07/28/2018; 20171207@83, BUD 06/05/2018; 20171016@27, BUD 04/14/2018; 20171204@15, BUD 06/02/2018; 20171006@57, BUD 04/04/2018; 20171018@62, BUD 04/16/2018; 20180116@24, BUD 07/15/2018.

Recall Number: D-0668-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone 55 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20171024@53, BUD 04/22/2018; 20180219@91, BUD 08/18/2018.

Recall Number: D-0680-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Estradiol 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

Batch or Lot Expiration Information

Lot# : 20171009@49, BUD 04/07/2018.

Recall Number: D-0667-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone 50 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# :0180126@48, BUD 07/25/2018; 20171109@48, BUD 05/08/2018

Recall Number: D-0654-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
one vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180111@104, BUD 07/10/2018.

Recall Number: D-0652-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone/Estradiol 60 mg/6 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, twist top surrounded by a wrapper Testosterone/Finasteride 80mg/8mg pellet Amber vial, twist top surrounded by a wrapper Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, twist top surrounded by a wrapper

Batch or Lot Expiration Information

Lot# : 20171010@76, BUD: 04/08/2018.

Recall Number: D-0637-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
3 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
CoEnzymeQ10 25mg/mL, 5mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

Batch or Lot Expiration Information

Lot# : 20171227@14, BUD 03/27/2018; 20180205@37, BUD 05/06/2018; 20180214@30, BUD 05/15/2018.

Recall Number: D-0635-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
5 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg) /mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180205@18, BUD 04/06/2018; 20180126@28, BUD 03/27/2018; 20180126@22, BUD 03/27/2018; 20180205@9, BUD 04/06/2018; 20180214@17, BUD 04/14/2018.

Recall Number: D-0671-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone/Anastrozole 60 mg/1 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

Batch or Lot Expiration Information

Lot# : 20171130@64, BUD 05/29/2018.

Recall Number: D-0650-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
five vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Progesterone 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 twist top surrounded by a wrapper,

Batch or Lot Expiration Information

Lot# : 20171220@10, BUD 06/18/201; 20171017@83, BUD 04/15/2018; 20171102@40, BUD 05/01/2018; 20180118@97, BUD 07/17/2018; 00180213@32, BUD 08/12/2018.

Recall Number: D-0642-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL amber vial and b) 50mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# a)
Lot# : 20180123@9, 20171222@11, BUD 4/14/2018, 20180214@7, BUD 08/14/2018. b)
Lot# : 20180221@3,BUD 08/21/2018, 20180214@6; BUD 08/14/2018.

Recall Number: D-0658-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
TM #4 (ALP 20/PAPAV/PHENT 2), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180219@27, 20180212@18, BUD 04/02/2018.

Recall Number: D-0664-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone 25 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180130@61, BUD 07/29/2018; 20180208@17, BUD 08/07/2018, 20170928@27, BUD 03/27/2018; 20171025@49, BUD 04/23/2018; 20171109@42, BUD 05/08/2018; 20171117@1, BUD 05/16/2018; 20180130@96, BUD 07/29/2018.

Recall Number: D-0663-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone 100 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20171212@17, BUD 06/10/2018; 20180205@40, BUD 08/04/2018; 20180208@42, BUD 08/07/2018; 20170929@42, BUD 03/28/2018; 20171013@33, BUD 04/11/2018; 20171020@25, BUD 04/18/2018; 20171025@52, BUD 04/23/2018; 20171101@70, BUD 04/30/2018; 20171106@31, BUD 05/05/2018; 20171116@17, BUD: 05/15/2018, 20171116@42, BUD 05/15/2018; 20180117@87, BUD: 07/16/2018; 20180201@76, BUD 07/31/2018; 20180220@67, BUD 08/19/2018; 20180202@67, BUD 08/01/2018.

Recall Number: D-0641-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
11 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# a)
Lot# : 20180129@18, BUD 4/14/2018 b)
Lot# : 20171127@6, 20180207@12, 20180108@16, BUD 04/14/2018.

Recall Number: D-0644-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
7 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180130@2, BUD 7/29/2018; 20180109@1, BUD 07/08/2018; 20180212@51, BUD 08/11/2018;, 20171212@4, BUD 06/10/2018; 20180123@6, BUD 07/22/2018; 20171204@4, BUD 06/02/2018; 20171228@15, BUD 03/28/2018.

Recall Number: D-0634-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180201@34, BUD 04/02/2018; 20180202@56, BUD 04/03/2018; 20180129@41, BUD 3/30/2018; 20180207@16, BUD 04/08/2018.

Recall Number: D-0679-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Estradiol 40 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

Batch or Lot Expiration Information

Lot# : 20171017@87, BUD 04/15/2018.

Recall Number: D-0674-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Estradiol 12.5 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

Batch or Lot Expiration Information

Lot# a)
Lot# : 20180219@88, 20180208@19, 20180219@45, BUD 08/18/2018.

Recall Number: D-0670-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone/Anastrozole 200 mg/20 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

Batch or Lot Expiration Information

Lot# : 20171116@3, BUD 05/15/2018; 20180221@72, BUD, 08/20/2018; 20171130@79, BUD 05/29/2018; 20180221@72, BUD 08/20/2018; 20180206@115, BUD 08/05/2018; 20171023@98, BUD 04/21/2018.

Recall Number: D-0659-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
TM #6 (ALP 25/PAPAV/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180206@7, BUD 03/23/2018, 20180212@41, BUD 03/29/2018, 20180219@40, BUD 04/02/2018.

Recall Number: D-0649-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
one vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Pregnenolone 100 mg (SD) pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20171017@85, BUD: 04/15/2018

Recall Number: D-0640-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Lipoic Acid 25mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180124@10, BUD 04/05/2018; 20180220@9, BUD 05/21/2018; 20180102@33, BUD 04/02/2018.

Recall Number: D-0636-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Biotin Suspension 10mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# :20180216@10, BUD 5/17/2018; 20180129@25, BUD 04/29/2018.

Recall Number: D-0665-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone 37.5 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180220@87, BUD 08/19/2018; 20171113@80, BUD 05/12/2018.

Recall Number: D-0651-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone/Anastrozole 120 mg/8 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20171220@11, BUD 06/18/2018; 20180201@33, BUD 07/31/2018.

Recall Number: D-0639-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
four vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
HCG 1000 units/mL, packaged in a) 2 mL and b) 6 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# a)
Lot# : 20180219@6, BUD 04/05/2018; b) 20180207@14, BUD 03/24/2018; 0180214@22, BUD 03/31/2018; 20180220@7, BUD 04/06/2018.

Recall Number: D-0662-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone 200 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3

Batch or Lot Expiration Information

Lot# : 20171128@9, BUD 05/27/2018; 20171201@74, BUD 05/30/2018; 20171211@68, BUD 06/09/2018; 20171218@51, BUD 06/16/2018; 20171222@6, BUD 06/20/2018; 20180209@62, BUD 08/08/2018; 20180223@46, BUD 08/22/2018; 20180223@33, BUD 08/22/2018; 20180219@5, BUD 08/18/2018; 20171010@11, BUD 04/08/2018; 20171019@19, BUD 04/17/2018; 20171031@69, BUD 04/29/2018; 20171102@27, BUD 05/01/2018; 20171110@87, BUD 05/09/2018; 20171114@12, BUD 05/13/2018; 20171122@57, BUD 05/21/2018; 20180112@56, BUD 07/11/2018; 20180116@77, BUD 07/15/2018; 20180122@92, BUD 07/21/2018; 20180202@69, BUD 08/01/2018; 20180205@111, BUD 08/04/2018; 20180212@102, BUD 08/11/2018.

Recall Number: D-0673-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Estradiol 10 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

Batch or Lot Expiration Information

Lot# : 20171201@84, BUD: 05/30/2018; 20180125@31, BUD 07/24/2018; 20180209@106, BUD 08/08/2018; 20171011@69, BUD 04/09/2018; 20171019@10, BUD 04/17/2018; 20171106@103, BUD 05/05/2018.

Recall Number: D-0678-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Estradiol 35 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

Batch or Lot Expiration Information

Lot# Lot: #20171102@42, BUD 05/01/2018.

Recall Number: D-0661-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
TM #3 (ALP10/PAPAV12/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180206@3, BUD 03/23/2018; 20180212@15, BUD 03/29/2018, 20180219@16, BUD 04/02/2018.

Recall Number: D-0656-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
MVI-7 (B1-100mg/B3-100mg, B5-252 mg, B6-102mg, Vit C-2500 mg, B12-10mg, Mag-1000 mg)/ vial liquid injectable, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180223@1, BUD 04/24/2018; 20180129@5, BUD 03/30/2018; 20180126@4, BUD 03/27/2018; 20180215@22, BUD 04/16/2018; 20180122@10, 20180126@4, BUD 03/23/2018; 20180202@27, BUD 04/03/2018; 20180208@5, 20180201@2, BUD 04/02/2018; # 20180207@2, BUD 04/08/2018, 20180214@11, BUD 04/15/2018; 20180215@22, BUD 04/16/2018.

Recall Number: D-0675-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Estradiol 15 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

Batch or Lot Expiration Information

Lot# : 20171204@117, BUD 06/02/2018; 20180129@14, BUD 07/28/2018; 20171011@111, BUD 04/09/2018.

Recall Number: D-0682-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone/Finasteride 80 mg/8 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

Batch or Lot Expiration Information

Lot# 20180110@57, 20180110@23 BUD 07/09/2018, 20171003@91, BUD 04/01/2018, 20171016@24, BUD 04/14/2018.

Recall Number: D-0660-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
TM (ALP 50/PAPAV 30/PHENT1.5 mg), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180219@31, BUD 04/02/2018; 20180212@42, 20180206@12, BUD 03/29/2018.

Recall Number: D-0669-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone 80 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20171213@93, BUD 06/11/2018; 20171220@78, BUD 06/18/2018; 20171017@41, BUD 04/15/2018; 20171117@2, BUD 05/16/2018; 20171213@93, BUD 06/11/2018.

Recall Number: D-0638-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
four vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180219@58, BUD 05/20/2018; 20180131@15, BUD 05/01/2018; 20180116@9, BUD 04/14/2018; 20180103@5, BUD 04/03/2018.

Recall Number: D-0653-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
7 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20171012@63, BUD 04/10/2018, 20171127@103, BUD 05/26/2018, 20180115@69, BUD 07/14/2018.

Recall Number: D-0666-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Testosterone 40 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20171214@90, BUD 06/12/2018; 20171113@81, BUD 05/12/2018; 20180220@58, BUD 08/19/2018.

Recall Number: D-0648-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
Naltrexone 200 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180219@90, BUD 08/18/2018

Recall Number: D-0645-2018

Reason for Recall
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Initiated
03-22-2018
Reported
04-25-2018
Quantity
15 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79619
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.
Partell Specialty Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NV only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Batch or Lot Expiration Information

Lot# : 20180212@22, BUD 03/29/2018; 20180226@64, BUD 04/02/2018.