TG United Recalls AMBI Antitussive Due to CGMP Deviations
TG United, Inc. is recalling 348 bottles of AMBI 25CPD/200GFN antitussive and expectorant due to CGMP deviations involving incorrect dosage.
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. Per the rubric, FDA Class II recalls with potential for significant injury or serious health consequences (such as incorrect dosage of medication) are rated as Severe (4).
Plain-English summary
TG United, Inc. is voluntarily recalling 348 16-ounce bottles of AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor. The product is an over-the-counter medication manufactured for AMBI Pharmaceuticals. The recall is limited to Lot # 12HQ007 with an expiration date of 07/14.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the source text indicates 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 the recalling firm for further instructions.
The recalled product
- Product
- AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.
- 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 (1)
- Lot # 12HQ007 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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