Recalls / Class II

Class IID-515-2013

Product

ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01

Affected lot / 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.

Why it was recalled

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

Recalling firm

Firm

TG United, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

16275 Aviation Loop Dr, N/A, Brooksville, Florida 34604-6805

Distribution

Quantity

242,470

Distribution pattern

FL, MS, SC, LA and TX

Timeline

Recall initiated

2013-01-30

FDA classified

2013-06-04

Posted by FDA

2013-06-12

Terminated

2016-09-30

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-515-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.