FDA recall D-1472-2022

Product

Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.

Reason for recall

Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

Distribution

Product was distributed to one retailer who may have further distributed the product to other distribution sites nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2022-08-04

Report date

2022-09-07

Termination date

2023-03-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1472-2022