FDA recall D-0914-2018

Mckesson Packaging Services · Class II · drug

Product

RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10

Reason for recall

Failed Stability Specifications

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2018-02-26
Report date
2018-03-14
Termination date
2020-09-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Concord, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0914-2018