FDA-Drug2013-06-12Class II

AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01

TG United, Inc.
Hazard

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

Sold states
FL, MS, SC, LA and TX
Affected count
886 bottles - 100-count tablets
Manufactured in
16275 Aviation Loop Dr, N/A, Brooksville, FL, United States
Products
AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-513-2013

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