TG United Recalls Underdosed OTC Tablets Due to Manufacturing Deviations
TG United, Inc. is recalling 386 bottles of TG 40PSE/400GFN tablets because they are underdosed or have an incorrect dosage regime.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves incorrect dosage of a pharmaceutical product, which fits the criteria for Severe severity.
Plain-English summary
TG United, Inc. is recalling 386 bottles of TG 40PSE/400GFN Tablets, 1000-count bottles, due to Current Good Manufacturing Practice (CGMP) deviations. The affected products are underdosed or have an incorrect dosage regime.
The recall involves specific lots with expiration dates ranging from December 2012 to June 2014. The affected units were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas.
Consumers who have purchased these products should stop using them and contact TG United, Inc. for further instructions or a refund.
The recalled product
- Product
- TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10
- Manufacturer
- TG United, Inc.
- Category
- Drug — OTC Tablets
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 (9)
- Lot# 11A006 Exp 12/12
- Lot# 11A007 Exp 12/12
- Lot# 11G004 Exp 06/14
- Lot# 11G005 Exp 06/14
- Lot# 12C004 Exp 02/14
- Lot# 12F007 Exp 05/14
- Lot# 12F008 Exp.05/14
- Lot #12F009 Exp. 05/14
- Lot# 12G005 Exp 06/14.
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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