TG United Recalls Underdosed AMBI Antihistamine Nasal Decongestant Syrup
TG United, Inc. is recalling 355 bottles of AMBI antihistamine and nasal decongestant syrup due to CGMP deviations resulting in underdosed products.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
TG United, Inc. is recalling 355 16-ounce bottles of AMBI 2CPM/15DM/5PEH, an over-the-counter antihistamine and nasal decongestant syrup. The product is manufactured for AMBI Pharmaceuticals and is identified by Lot # 12DQ004 with an expiration date of 03/14. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations that resulted in the products being underdosed or having an incorrect dosage regime.
The affected product was distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers who have purchased this specific lot of the medication should stop using it and contact their healthcare provider or pharmacist for guidance on appropriate alternatives or disposal.
The recalled product
- Product
- 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.
- Manufacturer
- TG United, Inc.
- Category
- Drug — OTC Syrup
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 12DQ004
- Exp. 03/14.
Distribution
Part of a larger recall action
This product is one of 44 recalled by TG United, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 44 products in this recall →Related recalls
Same manufacturer · TG United, Inc.
See all →- SevereTG United Recalls Trigofen DM Drops Due to Underdosing
FDA (Drugs) · 2013-06-12
- ModerateTG United Recalls Underdosed AMBI Cough Suppressant and Expectorant
FDA (Drugs) · 2013-06-12
- SevereTG United Recalls Z-Dex Syrup Due to Underdosing and Incorrect Dosage
FDA (Drugs) · 2013-06-12
- ModerateTG United Recalls CPM PSE Drops Due to CGMP Deviations
FDA (Drugs) · 2013-06-12
- SevereTG United Recalls Cardec DM Drops Due to Underdosing
FDA (Drugs) · 2013-06-12
Same hazard · underdosing
See all →- SevereBD Texium Closed System Drug Transfer Devices May Leak at Connector
FDA (Devices) · 2025-06-18
- HighBD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk
FDA (Devices) · 2025-06-18
- HighAlaris Pump Infusion Sets may leak at male luer connections
FDA (Devices) · 2025-06-18
- HighBD TEXIUM Closed Male Luer Drug Transfer Device Recall
FDA (Devices) · 2025-06-18
- HighBD Texium Needle-Free Syringe Recalled for Potential Leakage at Luer Interface
FDA (Devices) · 2025-06-18