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06-18-2013, 06:21 PM #1
- Join Date
- Aug 2012
- Merced, CA 95348-1422
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Recall: AMBI 40PSE/400GFN, 100 tablet bottle, OTC
Product Description AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01
Recall Number D-513-2013
Classification Class II
Code Info Lot # 12C007 Exp. 02/14; Lot # 12C008 Exp. 02/14.
Product Distributed Qty 886 bottles - 100-count tablets
Reason For Recall CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Event Id 64188
Product Type Drugs
TG United, Inc.
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern FL, MS, SC, LA and TX