Recalls / Class III
Class IIID-0323-2020
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
- Brand name
- Cvs Motion Sickness Fast Melting
- Generic name
- Meclizine Hydrochloride
- Active ingredient
- Meclizine Hydrochloride
- Route
- Oral
- NDC
- 59779-534
- FDA application
- M009
- Affected lot / code info
- 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
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Sato Pharmaceutical Inc.
- Manufacturer
- CVS Pharmacy, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20695 S Western Ave Ste 240, N/A, Torrance, California 90501-1834
Distribution
- Quantity
- 210,744 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-0323-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.