FDA-Drug2021-10-13Class II

Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01

RISING PHARMACEUTICALS
Hazard

Labeling: Incorrect Instructions

Sold states
to be entered
Affected count
1,344 bottles
Manufactured in
2 Tower Center Blvd, East Brunswick, NJ, United States
Products
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0005-2022

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