PlainRecalls
FDA Drug Moderate Class II Terminated

Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01

Reported: June 12, 2013 Initiated: January 30, 2013 #D-522-2013

Product Description

Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01

Reason for Recall

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

Details

Recalling Firm
TG United, Inc.
Units Affected
2706 bottles of 100 count tablets
Distribution
FL, MS, SC, LA and TX
Location
Brooksville, FL

Frequently Asked Questions

What product was recalled?
Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01. Recalled by TG United, Inc.. Units affected: 2706 bottles of 100 count tablets.
Why was this product recalled?
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 12, 2013. Severity: Moderate. Recall number: D-522-2013.