FDAClass IIJune 12, 2013

Ambi 2cpm/15dm/5peh recall: CGMP Deviations

AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals…

Why was Ambi 2cpm/15dm/5peh 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 # 12DQ004, Exp. 03/14.

Product
AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals…
Recalling firm
TG United, Inc.
Quantity
355 - 16 ounce bottles
Distribution
FL, MS, SC, LA and TX
Recall date
June 12, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls