TG United Recalls Underdosed AMBI Antihistamine Nasal Decongestant Syrup
TG United, Inc. is recalling 352 bottles of AMBI 25DPH/7.5PEH Antihistamine, Nasal Decongestant due to CGMP deviations resulting in underdosed products.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 (4) under the rubric, as it involves a product that may cause temporary or medically reversible adverse health consequences.
Plain-English summary
TG United, Inc. is recalling 352 16-ounce bottles of AMBI 25DPH/7.5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor. The product is an over-the-counter medication manufactured for AMBI Pharmaceuticals, Brooksville, FL, with NDC 66870-0226-16. The specific lot number is 12DQ005, and the expiration date is 03/14.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The source text states that the products are underdosed or have an incorrect dosage regime. This classification is designated as Class II by the FDA.
The affected product was distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on proper medication management.
The recalled product
- Product
- AMBI 25DPH/7.5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0226-16
- Manufacturer
- TG United, Inc.
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 # 12DQ005
- 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
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