Multi-event October 2019 FDA Recall Wal-dram 2 Quick-dissolving by Sato Pharmaceutical Inc.

This Multi-event Class III drug recall was voluntarily initiated by Sato Pharmaceutical Inc. on October 1, 2019 for the product Wal-dram 2 Quick-dissolving. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0325-2020 TERMINATED D-0322-2020 TERMINATED D-0324-2020 TERMINATED D-0323-2020 TERMINATED

Recall Number: D-0325-2020

Reason for Recall
Subpotent Drug
Initiated
10-01-2019
Reported
11-20-2019
Quantity
39,504 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83964
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.
Sato Pharmaceutical 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, Guam and Saipan
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-18-2020
Product Description About Product Description
Full technical description of the product.
Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 69842-288-01. UPC 5042849946

Batch or Lot Expiration Information

Lot# : AXTK, AXAK, AXZK, AXNK, AXBK, AXLK, AXPK, AXCK, Exp. Date Nov 2021

Recall Number: D-0322-2020

Reason for Recall
Subpotent Drug
Initiated
10-01-2019
Reported
11-20-2019
Quantity
21,864 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83964
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.
Sato Pharmaceutical 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, Guam and Saipan
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-18-2020
Product Description About Product Description
Full technical description of the product.
Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 49873-803-01. UPC 4987301603

Batch or Lot Expiration Information

Lot# : TXWW, TXTW, Exp. date Dec 2019; AXPS, AXLS, AXBS AXNS, Exp. date Oct 2021; AXZL, AXAL, AXTL, AXWL, Exp. date Jun 2021.

Recall Number: D-0324-2020

Reason for Recall
Subpotent Drug
Initiated
10-01-2019
Reported
11-20-2019
Quantity
a) 112,104 units b) 24,696 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83964
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.
Sato Pharmaceutical 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, Guam and Saipan
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-18-2020
Product Description About Product Description
Full technical description of the product.
WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (NDC 0363-1407-01, UPC 3 11917-18328 2 ) and b) 18-count boxes (NDC 0363-1407-02, UPC 3 11917-20318 8) Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501,

Batch or Lot Expiration Information

Lot# : a) AXWA, Exp. date Feb 2021; AXAB, Exp. date May 2021; AXLK, Exp. date Nov 2021; b) AXZP, Exp. date Jul 2021

Affected Packages Involved in this Recall

0363-1407-01 Wal-dram 2 Quick-dissolving
0363-1407-02 Wal-dram 2 Quick-dissolving

Recall Number: D-0323-2020

Reason for Recall
Subpotent Drug
Initiated
10-01-2019
Reported
11-20-2019
Quantity
210,744 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83964
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.
Sato Pharmaceutical 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, Guam and Saipan
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-18-2020
Product Description About Product Description
Full technical description of the product.
Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 59779-534-01. UPC 050428345535

Batch or Lot Expiration Information

Lot# : TXWP, TXTP, Exp. date Jul 2020; AXTZ, Exp. date Mar 2021; AXNP, Exp. date Jul 2021; AXBC, Exp. date Oct 2021; ZXWW, Exp. date Dec 2021

Affected Packages Involved in this Recall

59779-534-01 Cvs Motion Sickness Fast Melting