AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.
Reported: June 12, 2013 Initiated: January 30, 2013 #D-509-2013
Product Description
AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.
Reason for Recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Details
- Recalling Firm
- TG United, Inc.
- Units Affected
- 355 - 16 ounce bottles
- Distribution
- FL, MS, SC, LA and TX
- Location
- Brooksville, FL
Frequently Asked Questions
What product was recalled? ▼
AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.. Recalled by TG United, Inc.. Units affected: 355 - 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-509-2013.
Related Recalls
CPSC Moderate
Meijer Recalls Lullaby Lane and MCS Children's Sleepwear Due to Burn Hazard; Violates Mandatory Standard for Children's…
· 2026-02-19
FDA Food Moderate
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Passion Fruit- UPC# 5061033691882
Diva Fam Inc · 2026-02-11
FDA Food Moderate
Repackaged M&Ms candies, Net Wt 1.3 oz. Item BB458BG. Labeled with the following promotional company names. 1. Nex…
Beacon Promotions Inc · 2026-02-11
FDA Food Critical
Sofit, Seedless Red Dates, 12 oz package, Plastic bags, 50 packages per case
Tai Phat Wholesalers, LLC · 2026-02-11
FDA Food Moderate
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Wildcrafted- UPC# 5065006235073
Diva Fam Inc · 2026-02-11