Recalls / Class III
Class IIID-0325-2020
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
- Affected lot / code info
- Lot #: AXTK, AXAK, AXZK, AXNK, AXBK, AXLK, AXPK, AXCK, Exp. Date Nov 2021
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Sato Pharmaceutical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20695 S Western Ave Ste 240, N/A, Torrance, California 90501-1834
Distribution
- Quantity
- 39,504 units
- Distribution pattern
- Nationwide within the United States, Guam and Saipan
Timeline
- Recall initiated
- 2019-10-01
- FDA classified
- 2019-11-13
- Posted by FDA
- 2019-11-20
- Terminated
- 2020-08-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0325-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.