FDA recall D-519-2013

TG United, Inc. · Class II · drug

Product

BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16

Reason for recall

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

Distribution

FL, MS, SC, LA and TX

Key facts

Status: Terminated
Initiation date: 2013-01-30
Report date: 2013-06-12
Termination date: 2016-09-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brooksville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-519-2013