PlainRecalls
FDA Drug Moderate Class II Terminated

TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30

Reported: June 12, 2013 Initiated: January 30, 2013 #D-539-2013

Product Description

TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30

Reason for Recall

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

Details

Recalling Firm
TG United, Inc.
Units Affected
13,031 30 mL bottles.
Distribution
FL, MS, SC, LA and TX
Location
Brooksville, FL

Frequently Asked Questions

What product was recalled?
TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30. Recalled by TG United, Inc.. Units affected: 13,031 30 mL bottles..
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-539-2013.