Updated: With Table - Reese Pharmaceutical Company Announces the Voluntary Nationwide Recall of Certain Over-The-Counter Cold Relief Products that are Mislabeled.

[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]

 



Title: Updated: With Table - Reese Pharmaceutical Company Announces the Voluntary Nationwide Recall of Certain Over-The-Counter Cold Relief Products that are Mislabeled.

NOTE: This bulletin is being recirculated to include the table of affected products

Reese Pharmaceutical Company Announces the Voluntary Nationwide Recall of Certain Over-The-Counter Cold Relief Products that are Mislabeled.
Fri, 10 Dec 2010 18:42:00 -0600

Reese Pharmaceutical Company of Cleveland, Ohio has voluntarily recalled lot# 091612 only in 60-count size bottles identified under four different brand names, listed in the table below, because cold decongestant tablets (containing Acetaminophen 325 mg, Phenylephrine 5 mg & Chlorpheniramine Maleate 2 mg) were mislabeled as containing only 200mg Guaifenesin tablets. This mislabeling could cause a consumer to ingest the product and unknowingly be exposed to serious side effects of acetaminophen, phenylephrine or chlorpheniramine.

Product Name NDC# Lot#

Refenesen Expectorant (guaifenesin 200 mg tablets)

 

10956-752-60; 091612 05/11 SS/SCT36 06/26/09

Select Brand Mucus Relief Expectorant (guaifenesin 200 mg)

 

15127-129-60 091612 05/11 SS/SCT36 06/26/09

QC Medifin Expectorant (guaifenesin 200 mg)

 

63868-754-60 091612 05/11 SS/SCT36 06/26/09

Leader Cough Tabs Expectorant (guaifenesin 200 mg)

 

37205-466-72 091612 05/11 SS/SCT36 06/26/09


Manage your FDA Subscriptions:

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420


[Index of Archives]     [CDC News]     [NIH News]     [USDA News]     [Steve's Art]     [Camping in Yosemite]     [PhotoForum]     [SB Lupus]     [STB]

  Powered by Linux