Drug Enforcement D-503-2013

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

Status

Terminated

Classification

Class II

Report Date

June 12, 2013

Termination Date

September 30, 2016

Product Information

Product description
AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04
Product quantity
1398 - 4 ounce bottles
Reason for recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
FL, MS, SC, LA and TX

Location & Firm

Recalling firm
TG United, Inc.
Address
16275 Aviation Loop Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-503-2013
Event ID
64188
Recall initiation date
January 30, 2013
Center classification date
June 4, 2013
Code info
Lot # 12HQ002 Exp. 07/14.
More code info
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