Multi-event March 2022 FDA Recall Drug by Drug Depot, Inc., Dba Aps Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Drug Depot, Inc., Dba Aps Pharmacy on March 23, 2022 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0734-2022 TERMINATED D-0729-2022 TERMINATED D-0732-2022 TERMINATED D-0733-2022 TERMINATED D-0730-2022 TERMINATED D-0731-2022 TERMINATED D-0735-2022 TERMINATED D-0728-2022 TERMINATED

Recall Number: D-0734-2022

Reason for Recall
Lack of sterility assurance.
Initiated
03-23-2022
Reported
04-06-2022
Quantity
24 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89808
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.
Drug Depot, Inc., dba APS 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.
Nationwide in the USA including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-05-2023
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 76681, APS Pharmacy

Batch or Lot Expiration Information

Lot# Lot: 754381 BUD: 8/1/2022

Recall Number: D-0729-2022

Reason for Recall
Lack of sterility assurance.
Initiated
03-23-2022
Reported
04-06-2022
Quantity
1843 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89808
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.
Drug Depot, Inc., dba APS 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.
Nationwide in the USA including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-05-2023
Product Description About Product Description
Full technical description of the product.
(CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy

Batch or Lot Expiration Information

Lot# Lots: 749842 BUD: 7/13/2022; 749568 BUD: 7/12/2022; 752053 BUD: 7/23/2022; 752817 BUD: 7/25/2022; 757404 BUD: 8/21/2022; 757915 BUD: 8/23/2022; 757321 BUD: 8/20/2022; 753718 BUD: 7/30/2022

Recall Number: D-0732-2022

Reason for Recall
Lack of sterility assurance.
Initiated
03-23-2022
Reported
04-06-2022
Quantity
620 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89808
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.
Drug Depot, Inc., dba APS 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.
Nationwide in the USA including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-05-2023
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy

Batch or Lot Expiration Information

Lot# Lots: a)746000 BUD: 6/26/2022; b) 751472 BUD: 7/20/2022

Recall Number: D-0733-2022

Reason for Recall
Lack of sterility assurance.
Initiated
03-23-2022
Reported
04-06-2022
Quantity
0

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89808
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.
Drug Depot, Inc., dba APS 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.
Nationwide in the USA including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-05-2023
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable, Packaged in a multi dose 10ml vial, Formula ID 115498, APS Pharmacy

Batch or Lot Expiration Information

Lot# Lot:759312 BUD: 8/30/2022

Recall Number: D-0730-2022

Reason for Recall
Lack of sterility assurance.
Initiated
03-23-2022
Reported
04-06-2022
Quantity
846 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89808
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.
Drug Depot, Inc., dba APS 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.
Nationwide in the USA including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-05-2023
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b) (RM) 10 ML Formula ID 115125; APS Pharmacy

Batch or Lot Expiration Information

Lot# Lots: a) 745383 BUD: 6/20/2022; 759295 BUD: 8/30/2022; b) 745749 BUD: 6/21/2022; 746272 BUD: 6/27/2022

Recall Number: D-0731-2022

Reason for Recall
Lack of sterility assurance.
Initiated
03-23-2022
Reported
04-06-2022
Quantity
73 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89808
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.
Drug Depot, Inc., dba APS 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.
Nationwide in the USA including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-05-2023
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged in a multi dose 10ML vial, as a) (CA) 4 ML Formula ID 136164; b) (RM) 10 ML Formula ID 115962; APS Phar

Batch or Lot Expiration Information

Lot# Lots: a)750851 BUD: 7/18/2022; b) 754549 BUD: 8/2/2022

Recall Number: D-0735-2022

Reason for Recall
Lack of sterility assurance.
Initiated
03-23-2022
Reported
04-06-2022
Quantity
17 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89808
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.
Drug Depot, Inc., dba APS 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.
Nationwide in the USA including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-05-2023
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 127492, APS Pharmacy

Batch or Lot Expiration Information

Lot# Lot: 746269 BUD: 6/27/2022

Recall Number: D-0728-2022

Reason for Recall
Lack of sterility assurance.
Initiated
03-23-2022
Reported
04-06-2022
Quantity
6017 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89808
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.
Drug Depot, Inc., dba APS 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.
Nationwide in the USA including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-05-2023
Product Description About Product Description
Full technical description of the product.
GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy

Batch or Lot Expiration Information

Lot# Lots: 745708 BUD: 6/21/2022; 753364 BUD: 7/27/2022; 752508 BUD: 7/24/2022; 750313 BUD: 7/16/2022; 753020 BUD: 7/26/2022; 747712 BUD: 7/4/2022; 747974 BUD: 7/5/2022; 754802 BUD: 8/3/2022; 751158 BUD: 7/19/2022; 756837 BUD: 8/16/2022; 748939 BUD: 7/10/2022; 750842 BUD: 7/18/2022; 755742 BUD: 8/8/2022; 758691 BUD: 8/28/2022; 758432 BUD: 8/27/2022; 758975 BUD: 8/29/2022; 756643 BUD: 8/15/2022