PlainRecalls
FDA Drug Moderate Class II Terminated

Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01

Reported: June 12, 2013 Initiated: January 30, 2013 #D-518-2013

Product Description

Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01

Reason for Recall

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

Details

Recalling Firm
TG United, Inc.
Units Affected
8296 bottles - 100-count and 153,028 Bulk tablets
Distribution
FL, MS, SC, LA and TX
Location
Brooksville, FL

Frequently Asked Questions

What product was recalled?
Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01. Recalled by TG United, Inc.. Units affected: 8296 bottles - 100-count and 153,028 Bulk tablets.
Why was this product recalled?
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 12, 2013. Severity: Moderate. Recall number: D-518-2013.