Status
Terminated
Drug Enforcement D-532-2013
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Classification
Class II
Report Date
June 12, 2013
Termination Date
September 30, 2016
Product Information
- Product description
- TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10
- Product quantity
- 386 - 1000-count bottles
- Reason for recall
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- FL, MS, SC, LA and TX
Location & Firm
- Recalling firm
- TG United, Inc.
- Address
-
16275 Aviation Loop Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-532-2013
- Event ID
- 64188
- Recall initiation date
- January 30, 2013
- Center classification date
- June 4, 2013
- 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.
- More code info
- —