Status
Terminated
Drug Enforcement D-513-2013
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
- AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01
- Product quantity
- 886 bottles - 100-count tablets
- 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-513-2013
- Event ID
- 64188
- Recall initiation date
- January 30, 2013
- Center classification date
- June 4, 2013
- Code info
- Lot # 12C007 Exp. 02/14; Lot # 12C008 Exp. 02/14.
- More code info
- —