Multi-event March 2023 FDA Recall Drug by Remedyrepack Inc.

This Multi-event Class II drug recall was voluntarily initiated by Remedyrepack Inc. on March 20, 2023 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0503-2023 TERMINATED D-0495-2023 TERMINATED D-0499-2023 TERMINATED D-0494-2023 TERMINATED D-0491-2023 TERMINATED D-0497-2023 TERMINATED D-0492-2023 TERMINATED D-0501-2023 TERMINATED D-0500-2023 TERMINATED D-0502-2023 TERMINATED D-0490-2023 TERMINATED D-0496-2023 TERMINATED D-0493-2023 TERMINATED D-0498-2023 TERMINATED

Recall Number: D-0503-2023

Reason for Recall
cGMP Deviations
Initiated
03-20-2023
Reported
04-12-2023
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91980
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.
RemedyRepack Inc.
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.
RemedyRepack distributed product to consignees nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2023
Product Description About Product Description
Full technical description of the product.
Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

Batch or Lot Expiration Information

Lot# a): J0656821-103122, Exp. Date 11/30/2023; J0638547-080922, Exp. Date 08/31/2023; J0633575-071822, Exp. Date 07/31/2023
Lot# : b): B1965081-111622, Exp. Date 03/31/2025; B1857922-091922, B1765298-071322, B1786319-072922, B1706842-053122, Exp. Date 04/30/2023; B2003311-120822, Exp. Date 04/30/2025; B1955679-111122, Exp. Date 02/28/2025; B1878942-092922, Exp. Date 11/30/2024; B1823203-082622. Exp. Date 10/31/2024; B1706843-053122, Exp. Date 05/31/2023

Recall Number: D-0495-2023

Reason for Recall
cGMP Deviations
Initiated
03-20-2023
Reported
04-12-2023
Quantity
399 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91980
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.
RemedyRepack Inc.
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.
RemedyRepack distributed product to consignees nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2023
Product Description About Product Description
Full technical description of the product.
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.

Batch or Lot Expiration Information

Lot# : J0668398-121422, Exp. Date 12/31/2023; J0661225-111522, J0654053-101822 Exp. Date 11/30/2023; J0646383-091422, Exp. Date 09/30/2023

Recall Number: D-0499-2023

Reason for Recall
cGMP Deviations
Initiated
03-20-2023
Reported
04-12-2023
Quantity
3 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91980
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.
RemedyRepack Inc.
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.
RemedyRepack distributed product to consignees nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2023
Product Description About Product Description
Full technical description of the product.
Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00

Batch or Lot Expiration Information

Lot# : B1630017-040122, Exp. Date 04/30/2023

Recall Number: D-0494-2023

Reason for Recall
cGMP Deviations
Initiated
03-20-2023
Reported
04-12-2023
Quantity
17 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91980
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.
RemedyRepack Inc.
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.
RemedyRepack distributed product to consignees nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2023
Product Description About Product Description
Full technical description of the product.
Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.

Batch or Lot Expiration Information

Lot# : B1789178-080122, Exp. Date 07/31/2023; B1675475-050522, Exp. Date 05/31/2023

Recall Number: D-0491-2023

Reason for Recall
cGMP Deviations
Initiated
03-20-2023
Reported
04-12-2023
Quantity
a) 3,497 bottles, b) 729 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91980
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.
RemedyRepack Inc.
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.
RemedyRepack distributed product to consignees nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2023
Product Description About Product Description
Full technical description of the product.
Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

Batch or Lot Expiration Information

Lot# : a) J0679046-020123, Exp. Date 02/28/2024; J0669807-122122, Exp. Date 01/31/2024; J0662695-112222, Exp. Date 12/31/2023; J0654076-101822, J0654076-101822, Exp. Date 11/30/2023; J0642765-082922, Exp. Date 09/30/2023
Lot# : b) B1672408-050322, B1765902-071322, B1769634-071622, Exp. Date 04/30/2023; B1776907-072122, Exp. Date 09/30/2023; B1836636-090322, Exp. Date 11/30/2023; B1870344-092422, Exp. Date 01/31/2024; B1908452-101522, B1966455-111722, B2043099-010423, Exp. Date 05/31/2024

Recall Number: D-0497-2023

Reason for Recall
cGMP Deviations
Initiated
03-20-2023
Reported
04-12-2023
Quantity
16 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91980
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.
RemedyRepack Inc.
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.
RemedyRepack distributed product to consignees nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2023
Product Description About Product Description
Full technical description of the product.
Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00

Batch or Lot Expiration Information

Lot# : B1635780-040522, Exp. Date 04/30/2023

Recall Number: D-0492-2023

Reason for Recall
cGMP Deviations
Initiated
03-20-2023
Reported
04-12-2023
Quantity
a) 58 bottles, b) 6 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91980
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.
RemedyRepack Inc.
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.
RemedyRepack distributed product to consignees nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2023
Product Description About Product Description
Full technical description of the product.
Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

Batch or Lot Expiration Information

Lot# : a) J0665197-120522, Exp. Date 12/31/2023; J0642497-082722, Exp. Date 09/30/2023 J0638552-080922, Exp. Date 08/31/2023.
Lot# : b) B1808799-081622, Exp. Date 05/31/2024

Recall Number: D-0501-2023

Reason for Recall
cGMP Deviations
Initiated
03-20-2023
Reported
04-12-2023
Quantity
a) 399 bottles, b)445 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91980
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.
RemedyRepack Inc.
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.
RemedyRepack distributed product to consignees nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2023
Product Description About Product Description
Full technical description of the product.
Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

Batch or Lot Expiration Information

Lot# : a) NDC 70518-0375-03: J0674788-011123, Exp. Date 01/31/2024; J0664118-112922 J0664118-112922, Exp. Date 12/31/2023; J0653727-101722, Exp. Date 10/31/2023. NDC 70518-0375-01: B2057931-011223, Exp. Date 07/31/2025 b)
Lot# : B2075815-012523, Exp. Date 09/30/2025; B2011634-121322, Exp. Date 07/31/2025 B1970205-112022, Exp. Date 06/30/2024; B1862598-092022, Exp. Date 03/31/2024; B2077226-012523, B2070444-012023, Exp. Date 07/31/2025.

Recall Number: D-0500-2023

Reason for Recall
cGMP Deviations
Initiated
03-20-2023
Reported
04-12-2023
Quantity
132 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91980
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.
RemedyRepack Inc.
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.
RemedyRepack distributed product to consignees nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2023
Product Description About Product Description
Full technical description of the product.
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00

Batch or Lot Expiration Information

Lot# : J0668398-121422, Exp. Date 12/31/2023; J0661225-111522, J0654053-101822 Exp. Date 11/30/2023; J0646383-091422, Exp. Date 09/30/2023

Recall Number: D-0502-2023

Reason for Recall
cGMP Deviations
Initiated
03-20-2023
Reported
04-12-2023
Quantity
a) 76 bottles, b)151 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91980
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.
RemedyRepack Inc.
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.
RemedyRepack distributed product to consignees nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2023
Product Description About Product Description
Full technical description of the product.
Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

Batch or Lot Expiration Information

Lot# a): B2038806-123022, B2014185-121422, B1925528-102522, Exp. Date 07/31/2025.
Lot# : b): B2080829-012823, B1938007-110222, B2038746-123022, Exp. Date 07/31/2025.

Recall Number: D-0490-2023

Reason for Recall
cGMP Deviations
Initiated
03-20-2023
Reported
04-12-2023
Quantity
3 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91980
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.
RemedyRepack Inc.
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.
RemedyRepack distributed product to consignees nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2023
Product Description About Product Description
Full technical description of the product.
Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03

Batch or Lot Expiration Information

Lot# : J0620431-052322, Exp. Date 05/31/23

Recall Number: D-0496-2023

Reason for Recall
cGMP Deviations
Initiated
03-20-2023
Reported
04-12-2023
Quantity
a) 1,262 bottles, b) 95 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91980
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.
RemedyRepack Inc.
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.
RemedyRepack distributed product to consignees nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2023
Product Description About Product Description
Full technical description of the product.
Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

Batch or Lot Expiration Information

Lot# : a) J0675206-011223, J0669260-121922, Exp. Date 01/31/2024; J0656820-103122, J0647161-091722, Exp. Date 09/30/2023 Exp. Date 11/30/2023; J0621491-052722, Exp. Date 06/30/2023; J0638138-080822, Exp. Date 08/31/2023, J0610887-041122, Exp. Date 04/30/2023.
Lot# b) B1887315-100422, Exp. Date 02/28/2024; B1829906-083122, B1769715-071622, Exp. Date 09/30/2023; B1906605-101422, Exp. Date 02/28/2024; B1965118-111622, Exp. Date 02/28/2025.

Recall Number: D-0493-2023

Reason for Recall
cGMP Deviations
Initiated
03-20-2023
Reported
04-12-2023
Quantity
a) 147 bottles, b)70 bottles, c) 3 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91980
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.
RemedyRepack Inc.
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.
RemedyRepack distributed product to consignees nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2023
Product Description About Product Description
Full technical description of the product.
Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

Batch or Lot Expiration Information

Lot# : a) J0674153-010923, Exp. Date 01/31/2024; J0649447-092822, Exp. Date 10/31/2023; J0644887-090722, Exp. Date 09/30/2023; J0627309-062222, Exp. Date 06/30/2023; J0622569-060222, Exp. Date 06/30/2023. b) B1646259-041222, Exp. Date 04/30/2023; B2032846-122722, Exp. Date 01/31/2025 B2018675-121722, Exp. Date 05/31/2025; B1708230-060122, B1709748-060122, Exp. Date 06/30/2023; B1692572-051822, Exp. Date 05/31/2023; B1803110-081122, Exp. Date 12/31/2024. c) B1820672-082422, B1814883-082022, Exp. Date 09/30/2024.

Recall Number: D-0498-2023

Reason for Recall
cGMP Deviations
Initiated
03-20-2023
Reported
04-12-2023
Quantity
3,426 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91980
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.
RemedyRepack Inc.
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.
RemedyRepack distributed product to consignees nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2023
Product Description About Product Description
Full technical description of the product.
Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

Batch or Lot Expiration Information

Lot# : a) J0659819-110922, Exp. Date 11/30/2023; J0649932-093022, J0649917-093022 Exp. Date 10/31/2023, B2010060-121222, Exp. Date 03/31/24
Lot# : b) B1708575-060122, Exp. Date 05/31/2023; B1879236-092922, Exp. Date 12/31/2023