TG United Recalls Underdosed AMBI Cough Suppressant and Expectorant
TG United, Inc. is recalling 348 bottles of AMBI cough suppressant and expectorant due to CGMP deviations resulting in underdosed products.
What this means for you
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 due to CGMP deviations (underdosing), which fits the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported injuries.
Plain-English summary
TG United, Inc. is recalling 348 16-ounce bottles of AMBI 12.5 CPD/120GFN/5PEH, a cough suppressant, expectorant, and nasal decongestant. The product is identified by Lot # 12HQ006 and an expiration date of 07/14. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically that the products are underdosed or have an incorrect dosage regime.
The affected product was distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have purchased this product should stop using it and contact TG United, Inc. for further instructions or a refund. The product is an over-the-counter medication manufactured for AMBI Pharmaceuticals.
The recalled product
- Product
- AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0224-16
- Manufacturer
- TG United, Inc.
- Category
- Drug — OTC Cough and Cold
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 # 12HQ006
- 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.
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