Multi-event October 2021 FDA Recall Loratadine And Pseudoephedrine Sulfate by Sun Pharmaceutical Industries Inc

This Multi-event Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on October 12, 2021 for the product Loratadine And Pseudoephedrine Sulfate. The FDA reported the reason for recall as failed moisture limits. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0069-2022 TERMINATED D-0068-2022 TERMINATED

Recall Number: D-0069-2022

Reason for Recall
Failed Moisture Limits
Initiated
10-12-2021
Reported
11-03-2021
Quantity
46,584 blister packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88806
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-31-2023
Product Description About Product Description
Full technical description of the product.
AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15

Batch or Lot Expiration Information

Lot# AC09723, Exo, Date 11/2022

Affected Packages Involved in this Recall

63981-724-15 Kirkland Signature Allerclear D 24 Hr Extended Release

Recall Number: D-0068-2022

Reason for Recall
Failed Moisture Limits
Initiated
10-12-2021
Reported
11-03-2021
Quantity
22,752 blister packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88806
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-31-2023
Product Description About Product Description
Full technical description of the product.
Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15

Batch or Lot Expiration Information

Lot# : AC14635, Exp. Date 12/2022

Affected Packages Involved in this Recall

0904-5833-15 Loratadine And Pseudoephedrine Sulfate
0904-5833-48 Loratadine And Pseudoephedrine Sulfate