Drug Enforcement D-514-2013

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

Status

Terminated

Classification

Class II

Report Date

June 12, 2013

Termination Date

September 30, 2016

Product Information

Product description
Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10
Product quantity
2957 bottles 100-count tablets
Reason for recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
FL, MS, SC, LA and TX

Location & Firm

Recalling firm
TG United, Inc.
Address
16275 Aviation Loop Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-514-2013
Event ID
64188
Recall initiation date
January 30, 2013
Center classification date
June 4, 2013
Code info
Lot # 11E002 Exp. 04/2013.
More code info