RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I ___________________________________
PRODUCT
a) Aspire36, Next Generation Sexual Enhancer, Liquid Capsule Technology, proprietary blend of herbal  ingredients, 725mg, single blister packs or 3 and 12 count bottles, Recall # D-230-2008;
b) Aspire Lite, Female Sexual Enhancer, Liquid Capsule Technology, proprietary blend of herbal ingredients, 718mg, single blister packs or 3 and 12 count bottles, Recall # D-231-2008 CODE
a) Blister Pack Capsules: 053107, 071707, 102607, 121907, 
    3 count bottles: 071707, 092607A, 102607, 111707, 121907, 011708, 
    12 count bottles: 053107, 071707, 092607A, 102607, 111707, 120307, 121907, 011708;
b) Lot #s: 082907, 092607B, 112007, 121907, 011708A RECALLING FIRM/MANUFACTURER Recalling Firm: Palo Alto Laboratories Inc., Fort Pierce, FL, by press release on February 22, 2008, and by telephone or email or letter as of February 29, 2008.
Manufacturer: Liquidcapsule Manufacturing LLC, Miami Lakes, FL. Firm initiated recall is ongoing.
REASON
Unapproved New Drug: product found to contain Aildenafil in and Dimethyl sildenafil thione (sulfoaildenafil) analogs of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED).
VOLUME OF PRODUCT IN COMMERCE
1,008,737 Capsules
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II ___________________________________
PRODUCT
SPIRIVA HandiHaler, tiotropium bromide inhalation powder, 18 mcg per capsule, 30-capsule blister cards (NDC 0597-0075-41) and 90-capsule blister cards (NDC 0597-0075-47), Rx only, Recall # D-224-2008 CODE
Lots: 704577A, exp. 10/08; 705425A, exp. 11/08; 707703A, exp. 02/09; 707703B, exp. 02/09; 707987A, exp. 02/09; 708066A, exp. 02/09; 708307, exp. 03/09 RECALLING FIRM/MANUFACTURER Recalling Firm: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, by letters on June 9, 2008. 
Manufacturer: Boehringer Ingelheim Pharma KG, Ingelheim, Germany. Firm initiated recall is ongoing. 
REASON
Product may not meet specifications for aerodynamic particle size distribution throughout shelf life.
VOLUME OF PRODUCT IN COMMERCE
889,132 units
DISTRIBUTION
Nationwide

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PRODUCT
a) ACEON?, (perindopril erbumine) Tablets, 2 mg, Bottles of 100, Rx Only, NDC 0032-1101-01, 
    Recall # D-227-2008;
b) ACEON?, (perindopril erbumine) Tablets, 4 mg, Bottles of 100, Rx Only, NDC 0032-1102-01, 
    Recall # D-228-2008;
c) ACEON?, (perindopril erbumine) Tablets, 8 mg, Bottles of 100, Rx Only, NDC 0032-1103-01, 
    Recall # D-229-2008
CODE
a) Lot 3064835, Expiration: 08/2009;
b) Lot 3063489, Expiration: 12/2009, Lot 3063490, Expiration: 12/2009, and Lot 3064276, Expiration: 01/2010;
c) Lot 3063493, Expiration: 12/2009, Lot 3064277, Expiration: 01/2010, and Lot 3064278, Expiration: 01/2010 RECALLING FIRM/MANUFACTURER Recalling Firm: Solvay Pharmaceuticals, Inc., Marietta, GA, by letter on/about June 19, 2008.
Manufacturer: Patheon ? Cincinnati Operations, Cincinnati, OH. Firm initiated recall is ongoing.
REASON
Presence of foreign substance; possibility of trace amounts of latex.
VOLUME OF PRODUCT IN COMMERCE
23,676 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III ___________________________________
PRODUCT
Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP, 200mg/325mg/16mg, Rx only, 100 tablets, Activis Totowa LLC, NDC 52152-138-02, Also labeled under Amide Pharmaceutical Inc., NDC 52152-138-02, Soma Compound with Codeine Tablets, USP, Distributed by: MedPointe, NDC 0037-2403-01 and Qualitest, NDC 0603-2884-21, Recall # D-223-2008 CODE 60341A Apr-08 60484A1 May-08 60485A1 May-08 60713A1 Aug-08 61024A Nov-08 61025A Nov-08 70256A Apr-09 70257A Mar-09 70488A Jun-09 70702A Aug-09 RECALLING FIRM/MANUFACTURER Actavis Totowa LLC, Totowa, NJ, by letters on May 7, 2008. Firm initiated recall is ongoing. 
REASON
Superpotent; Codeine Phosphate
VOLUME OF PRODUCT IN COMMERCE
17,044 bottles: 8967 Amide, 4188 MedPointe, 1825 Qualitest DISTRIBUTION Nationwide

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PRODUCT
Hydrocortisone and Acetic Acid Otic Solution, USP, 10mL bottle, Rx only, NDC 0603-7039-39, Recall # D-225-2008 CODE
Lots: L003M06, exp. 6/08; L038E07A, exp.11/08; L055E07, exp. 11/08; L037G07, exp. 1/09; L033H07, exp. 2/09; L034H07, exp. 2/09; L035H07, exp. 2/09; L013K07, exp. 4/09 RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals LLC, Huntsville, AL, by letter on June 5, 2008. Firm initiated recall is ongoing.
REASON
Product fails specification for individual impurity.
VOLUME OF PRODUCT IN COMMERCE
52,259 units
DISTRIBUTION
Nationwide

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PRODUCT
PREMPRO? (conjugated estrogens/medroxyprogesterone acetate tablets) 0.45 mg/1.5 mg, Rx only, NDC 0046-0937-09. One carton contains 3 EZ-DIAL? Dispensers of 28 tablets each. 1 EZ-DIAL? Dispenser (NDC 0046-0937-08) contains 28 gold PREMPRO? Tablets containing 0.45 mg of the conjugated estrogens found in Premarin? and 1.5 mg of medroxyprogesterone acetate Recall # D-226-2008 CODE
Lot: C61131, exp. January 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Philadelphia, PA, by letters on June 12, 2008.
Manufacturer: Wyeth Pharmaceuticals, Inc., Rouses Point, NY. Firm initiated recall is ongoing.
REASON
Failed USP dissolution test requirements VOLUME OF PRODUCT IN COMMERCE
23,391 cartons of 3 dispensers
DISTRIBUTION
Nationwide