TG United Recalls AMBI Cough Syrup Due to Underdosing
TG United, Inc. is recalling 348 bottles of AMBI cough syrup because the product is underdosed or has an incorrect dosage regime.
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 health risks associated with dosage errors.
Plain-English summary
TG United, Inc. is recalling 348 16-ounce bottles of AMBI 3BRM/15DM/30PSE, an over-the-counter antihistamine, cough suppressant, and nasal decongestant in Berry Vanilla flavor. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where the products are underdosed or have an incorrect dosage regime.
The affected product is identified by Lot # 12HQ003 and an expiration date of 07/14. The product was distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas.
Consumers should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0230-16.
- 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 # 12HQ003
- 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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