PlainRecalls
FDA Drug Moderate Class II Terminated

NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: Larken Laboratories, Inc. Canton, MS 39046

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0507-2021

Product Description

NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: Larken Laboratories, Inc. Canton, MS 39046

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
24 bottles
Distribution
FL, GA, SC
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: Larken Laboratories, Inc. Canton, MS 39046. Recalled by Cardinal Health Inc.. Units affected: 24 bottles.
Why was this product recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0507-2021.