FDAClass IIJune 12, 2013

Poly Hist Forte recall: CGMP Deviations

Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01

Why was Poly Hist Forte 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# 12L005 Exp 10/14.

Product
Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01
Recalling firm
TG United, Inc.
Quantity
330158 Bulk tablets.
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