FDAFDA · Food and drugs·Recall number D-503-2013
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
Published June 12, 2013 · Recall initiated: January 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- TG United, Inc.
- Distributor
- FL, MS, SC, LA and TX
- Lot
- Lot # 12HQ002 Exp. 07/14.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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