Multi-event October 2021 FDA Recall Good Sense Childrens Pain And Fever by Perrigo Company Plc

This Multi-event Class II drug recall was voluntarily initiated by Perrigo Company Plc on October 26, 2021 for the product Good Sense Childrens Pain And Fever. 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-0609-2022 TERMINATED D-0616-2022 TERMINATED D-0621-2022 TERMINATED D-0617-2022 TERMINATED D-0579-2022 TERMINATED D-0600-2022 TERMINATED D-0581-2022 TERMINATED D-0596-2022 TERMINATED D-0595-2022 TERMINATED D-0588-2022 TERMINATED D-0590-2022 TERMINATED D-0625-2022 TERMINATED D-0612-2022 TERMINATED D-0597-2022 TERMINATED D-0602-2022 TERMINATED D-0592-2022 TERMINATED D-0614-2022 TERMINATED D-0622-2022 TERMINATED D-0628-2022 TERMINATED D-0594-2022 TERMINATED D-0586-2022 TERMINATED D-0598-2022 TERMINATED D-0583-2022 TERMINATED D-0593-2022 TERMINATED D-0623-2022 TERMINATED D-0620-2022 TERMINATED D-0611-2022 TERMINATED D-0613-2022 TERMINATED D-0619-2022 TERMINATED D-0603-2022 TERMINATED D-0601-2022 TERMINATED D-0624-2022 TERMINATED D-0608-2022 TERMINATED D-0606-2022 TERMINATED D-0615-2022 TERMINATED D-0627-2022 TERMINATED D-0629-2022 TERMINATED D-0589-2022 TERMINATED D-0626-2022 TERMINATED D-0610-2022 TERMINATED D-0604-2022 TERMINATED D-0591-2022 TERMINATED D-0582-2022 TERMINATED D-0585-2022 TERMINATED D-0587-2022 TERMINATED D-0605-2022 TERMINATED D-0607-2022 TERMINATED D-0580-2022 TERMINATED D-0618-2022 TERMINATED D-0599-2022 TERMINATED D-0584-2022 TERMINATED

Recall Number: D-0609-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
14,784 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009. NDC 21130-813-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0716, Exp 12/31/2022; 1FK1251, 1HK1196, Exp 02/28/2023

Affected Packages Involved in this Recall

21130-813-10 Signature Care Nasal Decongestant

Recall Number: D-0616-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
123,408 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Maxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-623-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0826, Exp 12/31/2022); 1FK1232, 1BK0964, Exp 01/31/2023

Affected Packages Involved in this Recall

55910-623-10 Dg Health Nasal

Recall Number: D-0621-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
15,264 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6319-1

Batch or Lot Expiration Information

Batch# Batch: 1BK0964, Exp 01/31/2023; 1FK1164, Exp 01/31/2023

Affected Packages Involved in this Recall

11822-6319-1 Nasal

Recall Number: D-0617-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
7,632 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0826, Exp 12/31/2022

Affected Packages Involved in this Recall

30142-388-10 Nasal

Recall Number: D-0579-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
14,868 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 50941-009-43

Batch or Lot Expiration Information

Batch# Batch: 1AK1031, Exp 12/31/2022

Recall Number: D-0600-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
561 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo pack. DS SR APAP 160MG CHLD BBGM/DF CHRY/GRP. UPC: 3 70030 11637 9

Batch or Lot Expiration Information

Batch# Batch: 1EV1874, Exp 11/02/2022

Recall Number: D-0581-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
4,992 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1321-97

Batch or Lot Expiration Information

Batch# Batch: 1BK0960, Exp 12/31/2022

Affected Packages Involved in this Recall

0536-1321-97 Rugby Childrens Acetaminophen

Recall Number: D-0596-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
5,184 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16

Batch or Lot Expiration Information

Batch# Batch: 1CK1274, Exp 02/28/2023

Affected Packages Involved in this Recall

30142-766-16 Infants Pain And Fever

Recall Number: D-0595-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
1,296 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16

Batch or Lot Expiration Information

Batch# Batch: 1CK1274, Exp 02/28/2023

Affected Packages Involved in this Recall

30142-766-16 Infants Pain And Fever

Recall Number: D-0588-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
20,448 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-818-26

Batch or Lot Expiration Information

Batch# Batch: 1BK1045, Exp 12/31/2022

Affected Packages Involved in this Recall

30142-818-26 Childrens Pain And Fever

Recall Number: D-0590-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
16,992 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC: 55910-251-26

Batch or Lot Expiration Information

Batch# Batch: 1CK1001, Exp 12/31/2022

Affected Packages Involved in this Recall

55910-251-26 Dg Health Childrens Pain And Fever
55910-251-28 Dg Health Childrens Pain And Fever
55910-251-34 Dg Health Childrens Pain And Fever

Recall Number: D-0625-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
13,824 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007. NDC 36800-388-10

Batch or Lot Expiration Information

Batch# Batch: 1FK1233, Exp 01/31/2023

Affected Packages Involved in this Recall

36800-388-10 Topcare Nasal

Recall Number: D-0612-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
19,584 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC., ELK GROVE VILLAGE, IL 60007. NDC 36800-907-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0716, Exp 12/31/2022

Affected Packages Involved in this Recall

36800-907-10 Topcare Nasal

Recall Number: D-0597-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
55,656 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentoneville, AR 72716. NDC: 49035-766-16

Batch or Lot Expiration Information

Batch# Batch: 1CK1274, Exp 02/28/2023

Affected Packages Involved in this Recall

49035-766-16 Parents Choice Infants Pain And Fever

Recall Number: D-0602-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
3,024 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 0113-0020-26

Batch or Lot Expiration Information

Batch# Batch: 1CK0963, Exp 12/31/2022

Affected Packages Involved in this Recall

0113-0020-26 Good Sense Childrens Pain And Fever
0113-0020-28 Good Sense Childrens Pain And Fever
0113-0020-34 Good Sense Childrens Pain And Fever

Recall Number: D-0592-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
111,888 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walmart, Inc., Bentonville, AR 72716. NDC: 49035-042-26

Batch or Lot Expiration Information

Batch# Batch: 1BK0962, Exp 12/31/2022, 1CK0999, Exp 01/31/2023

Affected Packages Involved in this Recall

49035-042-26 Equate Pain And Fever Childrens

Recall Number: D-0614-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
26,448 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC, 410 TERRY AVENUE N. SEATTLE, WA 9810. NDC 72288-388-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0826, Exp 12/31/2022); 1BK0964R, Exp 01/31/2023

Affected Packages Involved in this Recall

72288-388-10 Basic Care No Drip Nasal

Recall Number: D-0622-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
11,088 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
No Drip Nasal Decongestant, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009. NDC 21130-801-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0964, Exp 01/31/2023

Affected Packages Involved in this Recall

21130-801-10 Signature Care Nasal Decongestant

Recall Number: D-0628-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
2,302 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0716, Exp 12/31/2022

Affected Packages Involved in this Recall

41250-989-10 Nasal

Recall Number: D-0594-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
14,688 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-759-26

Batch or Lot Expiration Information

Batch# Batch: 1FK1252, 1GK0905, Exp 01/31/2023

Recall Number: D-0586-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
3,120 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202. NDC: 30142-818-26

Batch or Lot Expiration Information

Batch# Batch: 1BK1045, Exp 12/31/2022

Affected Packages Involved in this Recall

30142-818-26 Childrens Pain And Fever

Recall Number: D-0598-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
68,688 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-946-16

Batch or Lot Expiration Information

Batch# Batches: 1FK1027, 1FK1184, 1EK1046, Exp 02/28/2023

Affected Packages Involved in this Recall

49035-946-10 Equate Pain And Fever Infants
49035-946-16 Equate Pain And Fever Infants

Recall Number: D-0583-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
14,064 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0971-26

Batch or Lot Expiration Information

Batch# Batch: 1DK0917, 1GK0905, Exp 01/31/2023

Recall Number: D-0593-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
3,840 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, MADE WITH PRIDE & CARE FOR H-E-B SAN ANTONIO, TX 78204. NDC: 37808-759-26

Batch or Lot Expiration Information

Batch# Batch: 1GK0905, Exp 01/31/2023

Recall Number: D-0623-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
1,560 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-703-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0964, Exp 01/31/2023

Affected Packages Involved in this Recall

41163-703-10 Equaline Nasal

Recall Number: D-0620-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
3,744 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0826, Exp 12/31/2022

Affected Packages Involved in this Recall

30142-388-10 Nasal

Recall Number: D-0611-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
89,208 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Dist. by Target Corp., Mpls., MN 55403. NDC 11673-935-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0912, Exp 12/31/2022; 1FK1251, Exp 02/28/2023

Recall Number: D-0613-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
1,296 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC, 410 TERRY AVENUE N. SEATTLE, WA 9810. NDC 72288-388-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0964R, Exp 01/31/2023

Affected Packages Involved in this Recall

72288-388-10 Basic Care No Drip Nasal

Recall Number: D-0619-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
10,800 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-388-10

Batch or Lot Expiration Information

Batch# Batch: 1FK1164, Exp 01/31/2023

Affected Packages Involved in this Recall

41250-388-10 Nasal

Recall Number: D-0603-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
37,104 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Maximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC 410 TERRY AVENUE N.SEATTLE, WA 98109. NDC: 72288-703-10

Batch or Lot Expiration Information

Batch# Batch: 1FK1251, Exp 02/28/2023; 1BK0716, Exp 12/31/2022

Affected Packages Involved in this Recall

72288-703-10 Basic Care No Drip Nasal

Recall Number: D-0601-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
4,992 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 11673-105-26

Batch or Lot Expiration Information

Batch# Batch: 1CK0998, Exp 01/31/2023

Affected Packages Involved in this Recall

11673-105-26 Up And Up Childrens Acetaminophen
11673-105-28 Up And Up Childrens Acetaminophen

Recall Number: D-0624-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
36,864 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0826, Exp 12/31/2022

Affected Packages Involved in this Recall

30142-388-10 Nasal

Recall Number: D-0608-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
9,888 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6378-1

Batch or Lot Expiration Information

Batch# Batch: 11BK0827, Exp 12/31/2022

Affected Packages Involved in this Recall

11822-6378-1 Nasal

Recall Number: D-0606-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
21,4824 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Severe Congestion No Drip Nasal Spray Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-511-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0716, Exp 12/31/2022); 1CK0899, Exp 01/31/2023; 1FK1163, Exp 01/31/2023

Affected Packages Involved in this Recall

55910-511-10 Dg Health Nasal

Recall Number: D-0615-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
64,512 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
No Drip Nasal Mist, Oxymetazoline HCl 0.05% Nasal decongestant, 1 FL Oz (30 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-388-10

Batch or Lot Expiration Information

Batch# Batch: 1FK1164, Exp 01/31/2023

Affected Packages Involved in this Recall

59779-388-10 Nasal Mist

Recall Number: D-0627-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
79,776 botles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-696-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0931, Exp 12/31/2022; 1CK0900, Exp 01/31/2023; 1HK1196, Exp 02/28/2023

Affected Packages Involved in this Recall

55910-696-10 Dg Health Sinus Severe

Recall Number: D-0629-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
144 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0716, Exp 12/31/2022

Affected Packages Involved in this Recall

41250-989-10 Nasal

Recall Number: D-0589-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
30,144 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC: 49035-959-26

Batch or Lot Expiration Information

Batch# Batch: 1BK1045, Exp 12/31/2022

Affected Packages Involved in this Recall

49035-959-26 Equate Childrens Pain And Fever
49035-959-08 Equate Childrens Pain And Fever

Recall Number: D-0626-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
178,128 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC 49035-388-10

Batch or Lot Expiration Information

Batch# Batch: 1CK0897, 1FK1233, 1FK1232, Exp 01/31/2023

Affected Packages Involved in this Recall

49035-388-10 Equate Nasal
49035-388-00 Equate Nasal
49035-388-20 Equate Nasal

Recall Number: D-0610-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
2,664 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-343-10

Batch or Lot Expiration Information

Batch# Batch: 1FK1251, Exp 02/28/2023

Affected Packages Involved in this Recall

41163-343-10 Equaline Nasal

Recall Number: D-0604-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
3,168 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Packaged by Perrigo Company for: Big Lots Stores, Inc., P.O. Box 28523, Columbus, OH 43228-0523. NDC: 50594-719-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0827, Exp 12/31/2022

Recall Number: D-0591-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
26,832 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corp., Minneapolis, MN 55403 NDC: 11673-130-26

Batch or Lot Expiration Information

Batch# Batch: 1CK1146, Exp 02/28/2023

Affected Packages Involved in this Recall

11673-130-26 Up And Up Childrens Acetaminophen
11673-130-28 Up And Up Childrens Acetaminophen
11673-130-34 Up And Up Childrens Acetaminophen

Recall Number: D-0582-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
4,176 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 45802-203-26

Batch or Lot Expiration Information

Batch# Batch: 1GK0903, Exp 01/31/2023

Recall Number: D-0585-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
37,152 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC: 59779-946-16

Batch or Lot Expiration Information

Batch# Batch: 1CK1276, 1FK1184, 1GK0821 and 1EK1046, Exp 02/28/2023

Recall Number: D-0587-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
2,832 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed By Perrigo, Allegan, MI 49010. NDC: 0113-8959-26

Batch or Lot Expiration Information

Batch# Batch: 1BK1045, Exp 12/31/2022

Affected Packages Involved in this Recall

0113-8959-26 Good Sense Pain And Fever
0113-8959-34 Good Sense Pain And Fever

Recall Number: D-0605-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
7,200 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785. NDC 41520-108-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0716, Exp 12/31/2022; 1FK1251, Exp 02/28/2023

Affected Packages Involved in this Recall

41520-108-10 Careone Severe Congestion Nasal

Recall Number: D-0607-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
3,192 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785. NDC 41520-108-10

Batch or Lot Expiration Information

Batch# Batch: 1BK0716; Exp 12/31/2022); 1FK1251, Exp 02/28/2023

Affected Packages Involved in this Recall

41520-108-10 Careone Severe Congestion Nasal

Recall Number: D-0580-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
117552 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-313-26

Batch or Lot Expiration Information

Batch# Batch: 1BK0784, Exp 12/31/2022; 1CK0997, 1CK1083, Exp 01/31/2023

Affected Packages Involved in this Recall

49035-313-26 Equate Childrens Pain And Fever
49035-313-34 Equate Childrens Pain And Fever

Recall Number: D-0618-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
41,472 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed By MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152. NDC 0904-6761-30

Batch or Lot Expiration Information

Batch# Batch: 1BK0826, Exp 12/31/2022; 1FK1164, Exp 01/31/2023

Recall Number: D-0599-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
83760 packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 FL OZ (118 mL) bottles per pack, Distributed by Walmart Inc., Bentonville, AR 72716. NDC: 49035-313-26

Batch or Lot Expiration Information

Batch# Batch: 1BK0794, Exp 12/31/2022, 1BK1035, Exp 01/31/2023

Affected Packages Involved in this Recall

49035-313-26 Equate Childrens Pain And Fever
49035-313-34 Equate Childrens Pain And Fever

Recall Number: D-0584-2022

Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Initiated
10-26-2021
Reported
03-02-2022
Quantity
22,140 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88905
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.
Perrigo Company PLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-133-16

Batch or Lot Expiration Information

Batch# Batch: 1CK0907, Exp 01/31/2023

Affected Packages Involved in this Recall

11673-133-16 Up And Up Acetaminophen Infants
11673-133-26 Up And Up Acetaminophen Infants