Drug Enforcement D-515-2013

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
ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01
Product quantity
242,470
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-515-2013
Event ID
64188
Recall initiation date
January 30, 2013
Center classification date
June 4, 2013
Code info
Lot# 11L008 Exp. 10/13; Lot# 12A001 Exp. 12/13; Lot# 12A002 Exp. 12/13; Lot# 12A006 Exp. 12/13; Lot#12A006 Exp. 12/13; Lot# 12A007 Exp. 12/13; Lot#12D013 Exp. 03/14; Lot# 12F002 Exp. 05/14; Lot# 12H006 Exp.07/14; Lot# 12J001 Exp. 08/14; Lot# 12J001 Exp. 08/14; Lot# 12K005 Exp. 09/14; Lot #12M002 Exp. 11/14; Lot# 12M003 Exp. 11/14.
More code info
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