TG United Recalls Underdosed AMBI Cough Syrup Bottles
TG United, Inc. is recalling 348 bottles of AMBI cough 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is underdosing, which is a quality issue rather than a high-risk pathogen or critical structural defect, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
TG United, Inc. is recalling 348 16-ounce bottles of AMBI 12.5 CPD/100GFN/30PSE, an over-the-counter antitussive, expectorant, and nasal decongestant in raspberry flavor. The product is manufactured for AMBI Pharmaceuticals, Brooksville, FL, and carries NDC 66870-0223-16.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the affected products are underdosed or have an incorrect dosage regime. The affected lot is # 12HQ005 with an expiration date of 07/14.
The recalled 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 the recalling firm for further instructions.
The recalled product
- Product
- AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0223-16
- Manufacturer
- TG United, Inc.
- Category
- Drug — OTC Cough 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 # 12HQ005
- Exp. 07/14.
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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