RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I ___________________________________
PRODUCT
Methadone HCI Oral Solution, 20mg, Recall # D-232-2008 CODE VistaPharm Lot # 135100 Whitney Lot # 5364 L RECALLING FIRM/MANUFACTURER Whitney Labs, Ormond Beach, FL, by telephone on March 14, 2008. Firm initiated recall is ongoing. 
REASON
Misbranded; bottles labeled as containing 20mg Methadone HCI actually contains 260 mg Methadone HCI. 
VOLUME OF PRODUCT IN COMMERCE
143 bottles
DISTRIBUTION
AL, NC, NH, FL

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III ___________________________________
PRODUCT
Guanfacine Tablets, USP 1 mg, 100 and 500 count bottles, NDC 52152-118-04 , NDC 52152-118-02; 100 count bottles, NDC 0603-3774-21; 100 count bottles, NDC 0904-5579-60, Recall # D-234-2008 CODE
Lots: 60366A1 Apr-08 60583A1 Jun-08 60583A2 Jun-08 60746A1 Aug-08 60746A2 Aug-08 60955A1 Nov-08 60955A2 Nov-08 70012A1 Jan-09 70012A2 Jan-09 70230A1 Mar-09 70230A2 Mar-09 70329A1 Apr-09 70499A1 Jun-09 70634A1 Jul-09 70634A2 Jul-09 70943A1 Nov-09 70943A2 Nov-09 80042A1 Jan-10 80106A1 Feb-10 RECALLING FIRM/MANUFACTURER Actavis Totowa LLC, Totowa, NJ, by letters on April 30, 2008. Firm initiated recall is ongoing. 
REASON
Exceeded impurity specification.
VOLUME OF PRODUCT IN COMMERCE
18 lots
DISTRIBUTION
Nationwide
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PRODUCT
Guanfacine Tablets, USP 2 mg, 100 and 500 count bottles, Rx only, NDC 52152-119-04 - 500 tablets; NDC 52152-119-02 - 100 tablets, Recall # D-235-2008 CODE
Lots: 60317A1 Apr-08 60317A2 Apr-08 60509A1 Jun-08 60509A2 Jun-08 60956A1 Nov-08 60956A2 Nov-08 70011A1 Jan-09 70011A2 Jan-09 70491A1 Jun-09 70491A2 Jun-09 70635A1 Jul-09 70635A2 Jul-09 70944A1 Nov-09 70944A2 Nov-09 80101A2 Feb-10 80101A1 Feb 10 RECALLING FIRM/MANUFACTURER Actavis Totowa LLC, Totowa, NJ, by letters on April 30, 2008. Firm initiated recall is ongoing. 
REASON
Exceeded impurity specification. 
VOLUME OF PRODUCT IN COMMERCE
16 lots
DISTRIBUTION
Nationwide
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PRODUCT
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, 0.5mg/3mg, Sterile Unit Dose Vials, For Inalation Only, packaged as 6 pouches of 5 (3 ml) vials each (30 unit-dose vials) NDC 0093-6723-73 and 12 pouches of 5 (3 ml) vials (60 unit-dose vials) NDC number 0093-6723-74, Recall # D-236-2008 CODE Lot number W21181 exp 9/2009 and Lot number W21501 exp 10/2009 RECALLING FIRM/MANUFACTURER Recalling Firm: Teva Pharmaceuticals USA, North Wales, PA, by letter on May 21, 2008.
Manufacturer: IVAX Pharmaceuticals U.K., Ltd. Cheshire, UK. Firm initiated recall is ongoing. 
REASON
Failed pH Specification
VOLUME OF PRODUCT IN COMMERCE
2,123,450 vials
DISTRIBUTION
LA, NC, NJ, NV, OH, and PR



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