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 or incorrect dosage regimes.
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 agency classification is FDA Class II. Per the rubric, an FDA Class II recall involving a significant defect such as incorrect dosage (which can lead to treatment failure or adverse effects) aligns with the 'Severe' criteria, particularly when structural or significant quality defects are present.
Plain-English summary
TG United, Inc. is recalling 348 16-ounce bottles of AMBI 20DM100GFN10PEH, an over-the-counter antitussive, expectorant, and nasal decongestant in grape flavor. The product is manufactured for AMBI Pharmaceuticals, Brooksville, FL, and carries NDC 66870-0200-16.
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 specific lot number is 12DQ002, with an expiration date of 03/14.
The affected units were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on disposal or replacement.
The recalled product
- Product
- AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16
- Manufacturer
- TG United, Inc.
- Category
- Drug — OTC Cough & 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 # 12DQ002
- 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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