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.
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 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
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