FDA recall D-1504-2019

Pharma-Natural Inc. · Class II · drug

Product

TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16 Fl.oz. (474 mL) bottle, Kramer Novis, San Juan, PR 00917, NDC 52083-622-16.

Reason for recall

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Distribution

Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.

Key facts

Status
Terminated
Initiation date
2019-06-21
Report date
2019-07-31
Termination date
2021-10-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1504-2019