TG United Recalls Underdosed AMBI Cough Suppressant and Expectorant Bottles
TG United, Inc. is recalling specific lots of AMBI 40PSE/400GFN/20DM cough suppressant and expectorant bottles 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe).
Plain-English summary
TG United, Inc. is recalling 1,772 bottles of AMBI 40PSE/400GFN/20DM, a cough suppressant, expectorant, and nasal decongestant. The product is sold in 100-count bottles and is manufactured for AMBI Pharmaceuticals. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically that the products are underdosed or have an incorrect dosage regime.
The affected lots are 11D001 (Exp. 03/13), 11D002 (Exp. 03/13), 11K003 (Exp. 09/13), and 12C010 (Exp. 02/14). The product was distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. The National Drug Code (NDC) for the product is 66870-0409-01.
Consumers who have purchased these specific lots should stop using the product and contact their healthcare provider or the recalling firm for further instructions. The FDA 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.
The recalled product
- Product
- AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
- Manufacturer
- TG United, Inc.
- Category
- Drug — Over-the-Counter (OTC)
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 (4)
- Lot # 11D001 Exp. 03/13
- Lot # 11D002 Exp. 03/13
- Lot#11K003 Exp. 09/13
- Lot# 12C010 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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