Multi-event February 2023 FDA Recall Good Sense Aller Ease by L. Perrigo Company

This Multi-event Class II drug recall was voluntarily initiated by L. Perrigo Company on February 9, 2023 for the product Good Sense Aller Ease. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0900-2023 TERMINATED D-0905-2023 TERMINATED D-0909-2023 TERMINATED D-0903-2023 TERMINATED D-0907-2023 TERMINATED D-0906-2023 TERMINATED D-0904-2023 TERMINATED D-0911-2023 TERMINATED D-0910-2023 TERMINATED D-0908-2023 TERMINATED D-0912-2023 TERMINATED D-0901-2023 TERMINATED D-0902-2023 TERMINATED

Recall Number: D-0900-2023

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
02-09-2023
Reported
07-19-2023
Quantity
11,904 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91672
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.
L. Perrigo Company
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 within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2023
Product Description About Product Description
Full technical description of the product.
Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count cartons (NDC 72288-847-47 and 72288-847-37), Distributed By: Amazon.com Services LLC., 410 Terry Avenue N., Seattle, WA 98109.

Batch or Lot Expiration Information

Lot# a) 2GR0329, Exp. date 04/24
Lot# b) 2DR0472, Exp. date 02/23; 2MR0417, Exp. date 07/24

Affected Packages Involved in this Recall

72288-847-39 Basic Care Allergy
72288-847-47 Basic Care Allergy
72288-847-37 Basic Care Allergy

Recall Number: D-0905-2023

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
02-09-2023
Reported
07-19-2023
Quantity
360,184

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91672
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.
L. Perrigo Company
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 within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2023
Product Description About Product Description
Full technical description of the product.
Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave., Allegan, MI 49010 USA. NDC 63981-847-48

Batch or Lot Expiration Information

Lot# : 2DV1487, 2DV1870, 2DV1871, 2DV1873, 2EV1676, 2GV2132, 2HV2679, Exp. date 12/23; 2DV2000, exp. date 11/23; 2LV1573, 2MV1314, Exp. date 04/24; 2FV1764, 2FV1765 2FV1766, 2GV1579, 2GV1937, 2GV1941 , 2GV1942, 2GV2157, 2HV1886, 2HV1997, 2HV2019, 2HV2047, Exp. datev02/24; 2EV1666, 2EV1667, 2EV1668, 2EV1670, 2EV1671, 2EV1672, 2EV1674, 2EV1677, 2EV1678, 2HV2017, Exp. date 01/24.

Affected Packages Involved in this Recall

63981-847-48 Kirkland Signature Aller Fex

Recall Number: D-0909-2023

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
02-09-2023
Reported
07-19-2023
Quantity
32,904 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91672
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.
L. Perrigo Company
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 within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2023
Product Description About Product Description
Full technical description of the product.
allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811.

Batch or Lot Expiration Information

Lot# : a) 2CR0652, 2DR0464, 2DR0465,Exp. Date 12/23; 2ER0285, Exp. Date 01/24. b) 2DR0466, Exp. Date 12/23; 2ER0412, Exp. Date 01/24; 2GR0330, Exp. Date 04/24

Affected Packages Involved in this Recall

56062-847-22 Allergy Relief
56062-847-39 Allergy Relief
56062-847-95 Allergy Relief

Recall Number: D-0903-2023

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
02-09-2023
Reported
07-19-2023
Quantity
16,200 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91672
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.
L. Perrigo Company
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 within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2023
Product Description About Product Description
Full technical description of the product.
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 69842-0914-39

Batch or Lot Expiration Information

Lot# : 2DV1925, Exp. date 06/23

Recall Number: D-0907-2023

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
02-09-2023
Reported
07-19-2023
Quantity
15,504 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91672
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.
L. Perrigo Company
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 within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2023
Product Description About Product Description
Full technical description of the product.
Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78

Batch or Lot Expiration Information

Lot# : 2DR0351, Exp. date 12/23

Affected Packages Involved in this Recall

45802-847-78 Fexofenadine Hydrochloride

Recall Number: D-0906-2023

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
02-09-2023
Reported
07-19-2023
Quantity
59,688 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91672
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.
L. Perrigo Company
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 within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2023
Product Description About Product Description
Full technical description of the product.
allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.

Batch or Lot Expiration Information

Lot# : a) 2JE1882, Exp. date 01/24 b) 2FV1918, 2ER0411, Exp. date 01/24; 2GV1902, Exp. date 04/24; 2CR0652, 2DR0465, Exp. date 12/23; 2GR0329, Exp. date 04/24 c)2CR0653, 2DR0466, Exp. date 12/23; 2ER0287, 2ER0412, Exp. date 01/24

Affected Packages Involved in this Recall

79481-0847-1 Allergy Relief
79481-0847-0 Allergy Relief
79481-0847-2 Allergy Relief
79481-0847-4 Allergy Relief
79481-0847-3 Allergy Relief

Recall Number: D-0904-2023

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
02-09-2023
Reported
07-19-2023
Quantity
1,920 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91672
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.
L. Perrigo Company
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 within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2023
Product Description About Product Description
Full technical description of the product.
aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your Military Exchanges, By: Perrigo Company, Allegan, MI USA 49010. NDC 55301-847-39

Batch or Lot Expiration Information

Lot# : 2ER0285,Exp. date 01/24

Affected Packages Involved in this Recall

55301-847-39 Exchange Select Aller Ease

Recall Number: D-0911-2023

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
02-09-2023
Reported
07-19-2023
Quantity
6,216 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91672
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.
L. Perrigo Company
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 within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2023
Product Description About Product Description
Full technical description of the product.
Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New York, NY 10001. NDC 45 tablets: 80159-112-03

Batch or Lot Expiration Information

Lot# : 2DR0471, Exp. Date 12/23

Recall Number: D-0910-2023

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
02-09-2023
Reported
07-19-2023
Quantity
208,416 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91672
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.
L. Perrigo Company
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 within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2023
Product Description About Product Description
Full technical description of the product.
allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN 55403.

Batch or Lot Expiration Information

Lot# : a) 2HE2032, 2JE1882, 2JE2185 Exp. Date 01/24; b) 2DR0464, 2ER0410, Exp. Date 12/23; 2ER0286, 2ER0411, Exp. Date 01/24 c) 2DR0467, 2DR0468, 2DR0469, 2ER0288, Exp. Date 12/23 d) 2ER0414, Exp. Date 01/24, 2GR0333, Exp. Date 02/24

Recall Number: D-0908-2023

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
02-09-2023
Reported
07-19-2023
Quantity
32,376 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91672
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.
L. Perrigo Company
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 within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2023
Product Description About Product Description
Full technical description of the product.
Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010.

Batch or Lot Expiration Information

Lot# : a) 2DV1869, 2EV1613, 2EV1614, Exp. date 12/23; 2EV1820, 2FV1943, Exp. date 01/24; 2GV1893, Exp. date 04/24.
Lot# : b) 2CR0653, 2DR0466, Exp. date 12/23, 2ER2087, Exp. date 01/24

Affected Packages Involved in this Recall

0113-0847-39 Good Sense Aller Ease
0113-0847-95 Good Sense Aller Ease
0113-0847-22 Good Sense Aller Ease
0113-0847-00 Good Sense Aller Ease
0113-0847-47 Good Sense Aller Ease

Recall Number: D-0912-2023

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
02-09-2023
Reported
07-19-2023
Quantity
44,280 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91672
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.
L. Perrigo Company
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 within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2023
Product Description About Product Description
Full technical description of the product.
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007.

Batch or Lot Expiration Information

Lot# : a) 2FV1948, 2ER0285, 2ER0411, Exp. Date 01/24 b)2CR0653, Exp. Date 12/23 c)2GR0331, Exp. Date 04/24

Affected Packages Involved in this Recall

36800-691-13 Topcare Allergy Relief
36800-691-39 Topcare Allergy Relief
36800-691-22 Topcare Allergy Relief
36800-691-49 Topcare Allergy Relief
36800-691-95 Topcare Allergy Relief
36800-691-75 Topcare Allergy Relief

Recall Number: D-0901-2023

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
02-09-2023
Reported
07-19-2023
Quantity
23,868 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91672
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.
L. Perrigo Company
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 within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2023
Product Description About Product Description
Full technical description of the product.
Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale Club, 25 Research Drive, Westborough, MA 01581. NDC 68391-847-47

Batch or Lot Expiration Information

Lot# :2DV1863, 2HV2698, Exp. date 12/23; 2GV1583, Exp. date 02/24; 2GV1950, 2HV2697, Exp. Date 01/24.

Affected Packages Involved in this Recall

68391-847-47 Berkley Jensen Allergy Relief
68391-847-48 Berkley Jensen Allergy Relief

Recall Number: D-0902-2023

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
02-09-2023
Reported
07-19-2023
Quantity
3,240 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91672
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.
L. Perrigo Company
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 within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2023
Product Description About Product Description
Full technical description of the product.
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, Salisbury, NC 28147. NDC 72476-847-22

Batch or Lot Expiration Information

Lot# : 2JE2185, Exp. date 01/24

Affected Packages Involved in this Recall

72476-847-22 Careone Allergy Relief
72476-847-39 Careone Allergy Relief
72476-847-95 Careone Allergy Relief