Multi-event December 2019 FDA Recall Drug by Mprx, Inc. Dba Medical Park Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Mprx, Inc. Dba Medical Park Pharmacy on December 18, 2019 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in TX and the recall is currently terminated.

Reported Recall Events

D-0816-2020 TERMINATED D-0815-2020 TERMINATED D-0809-2020 TERMINATED D-0803-2020 TERMINATED D-0807-2020 TERMINATED D-0811-2020 TERMINATED D-0818-2020 TERMINATED D-0805-2020 TERMINATED D-0804-2020 TERMINATED D-0814-2020 TERMINATED D-0817-2020 TERMINATED D-0812-2020 TERMINATED D-0813-2020 TERMINATED D-0820-2020 TERMINATED D-0819-2020 TERMINATED D-0808-2020 TERMINATED D-0810-2020 TERMINATED D-0806-2020 TERMINATED

Recall Number: D-0816-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Squaric Acid 0.1% Topical Solution (Clinic) 30 mL

Batch or Lot Expiration Information

Lot# Lot: 61380:42 Use by: 05/04/2020

Recall Number: D-0815-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Sildenafil 80 mg capsules

Batch or Lot Expiration Information

Lot# Lot: 61404:42 Use by: 05/06/2020

Recall Number: D-0809-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
1 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Magic Bullet Supplement

Batch or Lot Expiration Information

Lot# Lot: 61048:99 Use by: 02/08/2020

Recall Number: D-0803-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
DHEA/Pregnenol One 10.25 MG Cap

Batch or Lot Expiration Information

Lot# Lot: L61406:42 Use by: 05/06/2020

Recall Number: D-0807-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
5 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Liothyronine (T3) 80 mcg SR cap

Batch or Lot Expiration Information

Lot# Lot: 61253:42 Use by: 04/01/2020

Recall Number: D-0811-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Progesterone 200 mg Troche

Batch or Lot Expiration Information

Lot# Lot: 61242:26 Use by: 02/28/2020

Recall Number: D-0818-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
9 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Tadalafil 20 mg Troche

Batch or Lot Expiration Information

Lot# Lots: 61137:42 Use by: 03/08/2020; 61324:99 Use by: 04/04/2020; 60856:42 Use by: 02/02/2020

Recall Number: D-0805-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
2 jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars

Batch or Lot Expiration Information

Lot# Lot: 61367:42 Use by: 04/28/2020

Recall Number: D-0804-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Finasteride/Biotin 1 mg/50 mcg

Batch or Lot Expiration Information

Lot# Lot: 60658:42 Use by: 12/28/2019

Recall Number: D-0814-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Sildenafil 200 mg Troche (Clinic)

Batch or Lot Expiration Information

Lot# Lot: 61392:42 Use by: 05/05/2020

Recall Number: D-0817-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
2 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
T3/T4 SR 9 mcg/38 mcg capsule

Batch or Lot Expiration Information

Lot# Lot: 61296:42Use by: 04/13/2020

Recall Number: D-0812-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Progesterone 50 mg capsules

Batch or Lot Expiration Information

Lot# Lot: 61215:26 Use by: 03/23/2020

Recall Number: D-0813-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
3 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Progesterone E4M SR 100 mg capsules

Batch or Lot Expiration Information

Lot# Lot: 61219:42 Use by: 03/24/2020

Recall Number: D-0820-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
3 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Testosterone Topical Cream 4%

Batch or Lot Expiration Information

Lot# Lot: 61463:42 Use by: 02/27/2020

Recall Number: D-0819-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
7 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Tadalafil 6 mg Capsule

Batch or Lot Expiration Information

Lot# Lots: 61229:26 Use by: 03/25/2020; 61229:42 Use by: 03/25/2020

Recall Number: D-0808-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
4 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Liothyronine (T3) 92.5 MCG

Batch or Lot Expiration Information

Lot# Lot: 61024:99 Use by: 02/20/2020

Recall Number: D-0810-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
2 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Naltrexone 4.5 mg capsule

Batch or Lot Expiration Information

Lot# Lot: 60564:42 Use by: 02/10/2020

Recall Number: D-0806-2020

Reason for Recall
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Initiated
12-18-2019
Reported
02-05-2020
Quantity
12 jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84527
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.
MPRX, Inc. dba Medical Park 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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2022
Product Description About Product Description
Full technical description of the product.
Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars

Batch or Lot Expiration Information

Lot# Lots: 61134:42 Use by: 01/31/2020; 61302:26 Use by: 04/14/2020; 61318:42 Use by: 04/19/2020