Multi-event April 2020 FDA Recall Drug by The Medicine Shoppe Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by The Medicine Shoppe Pharmacy on April 6, 2020 for the product Drug. The FDA reported the reason for recall as lack of processing control. The product was distributed in Florida and the recall is currently terminated.

Reported Recall Events

D-1217-2020 TERMINATED D-1219-2020 TERMINATED D-1218-2020 TERMINATED D-1216-2020 TERMINATED D-1210-2020 TERMINATED D-1182-2020 TERMINATED D-1177-2020 TERMINATED D-1180-2020 TERMINATED D-1185-2020 TERMINATED D-1181-2020 TERMINATED D-1192-2020 TERMINATED D-1178-2020 TERMINATED D-1199-2020 TERMINATED D-1175-2020 TERMINATED D-1190-2020 TERMINATED D-1198-2020 TERMINATED D-1187-2020 TERMINATED D-1226-2020 TERMINATED D-1209-2020 TERMINATED D-1176-2020 TERMINATED D-1228-2020 TERMINATED D-1213-2020 TERMINATED D-1196-2020 TERMINATED D-1224-2020 TERMINATED D-1215-2020 TERMINATED D-1212-2020 TERMINATED D-1205-2020 TERMINATED D-1193-2020 TERMINATED D-1188-2020 TERMINATED D-1183-2020 TERMINATED D-1204-2020 TERMINATED D-1189-2020 TERMINATED D-1220-2020 TERMINATED D-1195-2020 TERMINATED D-1222-2020 TERMINATED D-1194-2020 TERMINATED D-1225-2020 TERMINATED D-1184-2020 TERMINATED D-1208-2020 TERMINATED D-1197-2020 TERMINATED D-1203-2020 TERMINATED D-1186-2020 TERMINATED D-1179-2020 TERMINATED D-1223-2020 TERMINATED D-1211-2020 TERMINATED D-1207-2020 TERMINATED D-1201-2020 TERMINATED D-1221-2020 TERMINATED D-1227-2020 TERMINATED D-1202-2020 TERMINATED D-1200-2020 TERMINATED D-1206-2020 TERMINATED D-1191-2020 TERMINATED D-1214-2020 TERMINATED

Recall Number: D-1217-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est (1:1)/Progesterone/Testosterone 2.5/150/1.5 mg/mL Versabase CR 90 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45280 Discard by: 9/23/2020

Recall Number: D-1219-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 jar

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45221 Discard by: 9/12/2020

Recall Number: D-1218-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 jar

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est (8:2)/Progesterone/Testosterone 0.5/75 mg per 0.2 mL Cream 6 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 44518 Discard by: 3/15/2020

Recall Number: D-1216-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 jar

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est (50/50/Progesterone 0.2 mg/70 mg Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45110 Discard by: 8/20/2020

Recall Number: D-1210-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Hydrocortisone in Aquaphor/Therapeutic Moisturizing Cream 100 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45211 Discard by: 9/9/2020

Recall Number: D-1182-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
7 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Estradiol Vag Cream 0.01% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 44967 Discard by: 7/10/2020; 45171 Discard by: 9/2/2020

Recall Number: D-1177-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Fluorouracil (5-FU) 4.5% Cream 100 GM, tube Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45044 Discard by: 8/2/2020

Recall Number: D-1180-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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 (Loxoral) 4.5 mg Capsules, 60 count bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 44898 Discard by: 3/23/2020

Recall Number: D-1185-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Estradiol 1.8 mg capsule 30 cap bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45073 Discard by: 8/7/2020

Recall Number: D-1181-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Estradiol/Progesterone/Testosterone 1.5/100/1.25 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 44560 Discard by: 03/24/2020

Recall Number: D-1192-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est 1:1/Progesterone/Testosterone 1mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45108 Discard by: 8/18/2020

Recall Number: D-1178-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
2 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 44767 Discard by: 5/17/2020

Recall Number: D-1199-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
2 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est 1:1/Progesterone/Testosterone 2.0/100/0.25 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45023 Discard by: 7/27/2020; 45268 Discard by: 9/27/2020

Recall Number: D-1175-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
8 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Estriol Vaginal Cream (0.1%) 1 mg Cream 30 GM tubes, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45036 Discard by: 7/31/2020; 45075 Discard by:8/7/2020

Recall Number: D-1190-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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/Versa Base 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45104 Discard by: 8/18/2020

Recall Number: D-1198-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est 8:2/Progesterone/Testosterone DHEA 4.0/100/1/25.0 mg capsules 90 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45130 Discard by: 8/25/2020

Recall Number: D-1187-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est (8:2) Progest/Test 2/80/3 mg/mL cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45098 Discard by: 8/16/2020

Recall Number: D-1226-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
2 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository (Pink) 48 suppositories, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45247 Discard by: 9/19/2020

Recall Number: D-1209-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 box

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Estriol 5 mg Suppository 36 each box, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45179 Discard by: 9/5/2020

Recall Number: D-1176-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
4 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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 W/Cosmetic HRT Base 100 MG (10%) Cream 30 GM, tubes Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45027 Discard by: 07/27/2020

Recall Number: D-1228-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Levothyroxin (T4)/Liothyronine (T3) SR 130 mg/175 mg capsule 21 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45274 Discard by: 9/27/2020

Recall Number: D-1213-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est (50/50)/Progesterone/Testosterone 1.5 mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 44840 Discard by: 6/1/2020

Recall Number: D-1196-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Diethylstilbestrol 1 mg capsule 300 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45102 Discard by: 8/17/2020

Recall Number: D-1224-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 jar

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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 w/Cosmetic HRT Base 20 mg (2%) Cream 30 GM jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Unknown

Recall Number: D-1215-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est (8:2)/Progesterone 2/100 mg/mL capsule 90 caps bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45239 Discard by: 9/16/2020

Recall Number: D-1212-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est (1:1)/Progesterone/Testosterone 2.0 mg/40 mg/1.0 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 44892 Discard by: 4/15/2020

Recall Number: D-1205-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Paregoric Compound (contains Morphine) Solution 480 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45161 Discard by: 5/4/2020

Recall Number: D-1193-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est (8:2)/DHEA/Testosterone 0.8 mg/ 9/0.4 mg/0.2 mg/mL Cream 6 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 44798 Discard by: 5/22/2020

Recall Number: D-1188-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est (1:1) Progest/Test 0.5 mg/1.5 mg/mL cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45100 Discard by: 8/16/2020

Recall Number: D-1183-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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 w/ Atrevis 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 44965 Discard by: 7/10/2020

Recall Number: D-1204-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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 in Atrevis 50 mg/mL Gel 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 44488 Discard by: 8/22/2020

Recall Number: D-1189-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est (1:1) Progesterone/Testost 1.0 mg/60 mg/0.5 mg/mL Cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45116 Discard by: 8/22/2020

Recall Number: D-1220-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Paregoric Alternate Elixir 300 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45231 Discard by: 6/16/2020

Recall Number: D-1195-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 box

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Ergotamine Tartrate 1 mg/Caffeine 100 mg Base Suppository (Pink) 48 count box, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45247 Discard by: 9/19/2020

Recall Number: D-1222-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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 in Atrevis 75 mg/mL Gel 90 GMS tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45235 Discard by: 9/15/2020

Recall Number: D-1194-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45077 Discard by: 3/12/2020

Recall Number: D-1225-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 jar

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45240 Discard by: 6/18/2020

Recall Number: D-1184-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
3 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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 w/ Atrevis 100 mg/mL GEL, 90 gm pump, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45114 Discard by: 08/20/2020; 45139 Discard by: 8/27/2020

Recall Number: D-1208-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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/mL Suspension 30 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45177 Discard by: 9/4/2020

Recall Number: D-1197-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est 8:2/Progesterone 2.5 mg/150/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 44908 Discard by: 6/17/2020

Recall Number: D-1203-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
2 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est (50/50)/Progesterone 1.25 mg/80 mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45006 Discard by: 7/18/2020; 45251 Discard by: 9/22/2020

Recall Number: D-1186-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est (1:1) Progest/Test 0.5 mg/40 mg/10.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 44894 Discard by: 6/15/2020

Recall Number: D-1179-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM, tube Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 44639 Discard by: 11/28/2020

Recall Number: D-1223-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 jar

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 44552 Discard by: 3/23/2020

Recall Number: D-1211-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% Cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45212 Discard by: 9/9/2020

Recall Number: D-1207-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Clobetasol Mouth Rinse 0.05% Solution 450 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45169 Discard by: 9/2/2020

Recall Number: D-1201-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est 1:1/Progest/DHEA 0.5 mg/180 mg/25 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 44850 Discard by: 6/4/2020

Recall Number: D-1221-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 jar

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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/Natacream 20 mg/2% mL Cream 60 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45233 Discard by: 9/15/2020

Recall Number: D-1227-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
2 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Betahistine 16 mg Capsule 180 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45266 Discard by: 9/26/2020

Recall Number: D-1202-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est (8:2)/Progest/Test/DHEA 6/50/0.5/10 mg/mL Cream 30 mL, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45148 Discard by: 8/30/2020

Recall Number: D-1200-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 jar

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est 1:1/Progest/DHEA 1/40/5 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45146 Discard by: 8/30/2020

Recall Number: D-1206-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Hydromorphone Oral 1 mg/mL Solution 240 mL, bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45163 Discard by: 9/1/2020

Recall Number: D-1191-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
3 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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 Capsules 90 capsules, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45106 Discard by: 8/16/2020; 45128 Discard by: 8/25/2020; 45227 Discard by: 9/14/2020

Recall Number: D-1214-2020

Reason for Recall
Lack of Processing Control
Initiated
04-06-2020
Reported
04-22-2020
Quantity
1 jar

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85404
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.
The Medicine Shoppe 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.
Florida
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.
Bi-Est (50/50)/Progesterone/Testost 1.5/100/0.5 mg Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Batch or Lot Expiration Information

Lot# Lot: 45132 Discard by: 8/26/2020