FDA recall D-1630-2019

LNK International, Inc. · Class II · drug

Product

Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1

Reason for recall

Microbial contamination of non-sterile product

Distribution

USA Nationwide

Key facts

Status
Terminated
Initiation date
2019-07-10
Report date
2019-08-07
Termination date
2023-06-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1630-2019