Recalls / Class III
Class IIID-0322-2020
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
- Affected lot / code info
- Lot #: TXWW, TXTW, Exp. date Dec 2019; AXPS, AXLS, AXBS AXNS, Exp. date Oct 2021; AXZL, AXAL, AXTL, AXWL, Exp. date Jun 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
- 21,864 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-0322-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.