TG United Recalls AMBI 40PSE/400GFN Tablets Due to CGMP Deviations
TG United, Inc. is recalling 886 bottles of AMBI 40PSE/400GFN tablets because the products are underdosed or have an incorrect dosage regime.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves underdosed medication or incorrect dosage regimes, which poses a risk of harm to patients relying on the medication for therapeutic effect.
Plain-English summary
TG United, Inc. is recalling 886 bottles of AMBI 40PSE/400GFN, 100 tablet bottles. The product is an over-the-counter medication manufactured for AMBI Pharmaceuticals in Brooksville, Florida. The specific NDC number is 66870-0408-01.
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 lots are # 12C007 and # 12C008, both with an expiration date of 02/14.
The recalled products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers should check their medication for these specific lot numbers and expiration dates. If the product matches the description, consumers should stop using it and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01
- 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 # 12C007 Exp. 02/14
- Lot # 12C008 Exp. 02/14.
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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