FDAClass IIJune 12, 2013

Brompheniramine/pseudoephedrine DM recall: CGMP Deviations

BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven…

Why was Brompheniramine/pseudoephedrine DM recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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
BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven…
Recalling firm
TG United, Inc.
Quantity
22,721 - 16 ounce bottles
Distribution
FL, MS, SC, LA and TX
Recall date
June 12, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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