Product Detail

Product Description BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16

Recall Number D-519-2013

Classification Class II

Code Info Lot# 12B001 Exp. 01/14; Lot# 12B001 Exp. 01/14; Lot# 12B002
Exp 01/14; Lot# 12F013 Exp. 05/14; Lot# 12F013 Exp. 05/14.

Product Distributed Qty 22,721 - 16 ounce bottles

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

Event Detail

Event Id 64188

Product Type Drugs

Status Ongoing
Recalling Firm
TG United, Inc.
City Brooksville
State FL
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-01-30

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern FL, MS, SC, LA and TX