PlainRecalls
FDA Drug Moderate Class II Terminated

Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60

Reported: June 12, 2013 Initiated: January 30, 2013 #D-530-2013

Product Description

Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60

Reason for Recall

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

Details

Recalling Firm
TG United, Inc.
Units Affected
977,719 Bulk Tablets
Distribution
FL, MS, SC, LA and TX
Location
Brooksville, FL

Frequently Asked Questions

What product was recalled?
Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60. Recalled by TG United, Inc.. Units affected: 977,719 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-530-2013.