Recalls / Class II
Class IID-532-2013
Product
TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10
- Affected lot / code info
- 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.
Why it was recalled
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recalling firm
- Firm
- TG United, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 16275 Aviation Loop Dr, N/A, Brooksville, Florida 34604-6805
Distribution
- Quantity
- 386 - 1000-count bottles
- Distribution pattern
- FL, MS, SC, LA and TX
Timeline
- Recall initiated
- 2013-01-30
- FDA classified
- 2013-06-04
- Posted by FDA
- 2013-06-12
- Terminated
- 2016-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-532-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.