FDA recall D-1367-2019

Torrent Pharma Inc · Class II · drug

Product

Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongestant, Cherry Flavored, Alcohol Free, (Chlorpheniramine Maleate, USP 2 mg, Dextromethorphan HBr, USP 10 mg, Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10mL)), 4 Fl. oz. bottle, NDC: 0536-2310-97, Distributed by Rugby Laboratories, Livonia MI 48152.

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Distribution

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

Key facts

Status
Terminated
Initiation date
2019-05-21
Report date
2019-06-19
Termination date
2020-10-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Levittown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1367-2019