FDA recall D-0162-2016

Product

RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.

Reason for recall

Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.

Distribution

U.S. Nationwide

Key facts

Status

Terminated

Initiation date

2015-10-21

Report date

2015-11-11

Termination date

2016-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0162-2016