AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16
Reported: June 12, 2013 Initiated: January 30, 2013 #D-504-2013
Product Description
AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16
Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Details
- Recalling Firm
- TG United, Inc.
- Units Affected
- 348 - 16 ounce bottles.
- Distribution
- FL, MS, SC, LA and TX
- Location
- Brooksville, FL
Frequently Asked Questions
What product was recalled? ▼
AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16. Recalled by TG United, Inc.. Units affected: 348 - 16 ounce bottles..
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-504-2013.
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