Unipharma, Llc.

FDA Regulatory Profile

Summary

Total Recalls
16
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0133-2020Class IIDrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL ESeptember 23, 2019
D-0132-2020Class IIDrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.September 23, 2019
D-1633-2019Class IICVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer, 30 single-useJuly 15, 2019
D-1631-2019Class IICVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral SolutioJuly 15, 2019
D-1632-2019Class IIDrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor,July 15, 2019
D-1306-2019Class IICVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant GuaifMay 2, 2019
D-1300-2019Class IICVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral SolutioMay 2, 2019
D-1297-2019Class IICVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough SuppressanMay 2, 2019
D-1305-2019Class IIDrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Single-Use Vials, Drug FrMay 2, 2019
D-1304-2019Class IICVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 May 2, 2019
D-1296-2019Class IICVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use May 2, 2019
D-1303-2019Class IIDrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measured Single-Use May 2, 2019
D-1302-2019Class IICVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 SingleMay 2, 2019
D-1299-2019Class IIDrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measured Single-Use May 2, 2019
D-1301-2019Class IIDrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed BeMay 2, 2019
D-1298-2019Class IIDrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured SinMay 2, 2019