JULY 2008

JULY 2008

WEEK ENDING JULY 5

Jack Distribution, LLC. Issues Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient

Jack Distribution, LLC, 1501 Green Road Unit C Pompano Beach, Florida 33064 and its wholesale distributors G & N works, Inc., and Devine Distribution, Inc., is recalling the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10).

Jack Distribution, LLC, is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Rize 2 and Rose 4 Her samples from lots manufactured and packaged in 2007 found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that these lots of Rize 2 The Occasion and Rose 4 Her contain thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains that this ingredient is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

The company advises that any unused portions from these lot numbers be returned to the place of purchase for a full refund of purchase price. G & N Works and Devine Distribution are not shipping any Rize 2 or Rose 4 Her that is in stock while additional samples are being tested, they expect to begin shipping again in 2-4 weeks.

Rize 2 and Rose 4 Her are sold in adult stores, vitamin & nutrition shops, convenience stores, and via the internet nationwide. The Rize 2 product is sold as a (single blister pack, three count bottles, twelve count bottles, and thirty count bottles. Rose 4 Her is only available in single blister packs and three count bottles.

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,
b) Aspire Lite, Female Sexual Enhancer, Liquid Capsule Technology, proprietary blend of herbal ingredients, 718mg, single blister packs or 3 and 12 count bottles,
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,
Manufacturer: Liquidcapsule Manufacturing LLC, Miami Lakes, FL.
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

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,
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,
Manufacturer: Boehringer Ingelheim Pharma KG, Ingelheim, Germany.
REASON Product may not meet specifications for aerodynamic particle size distribution throughout shelf life.
VOLUME OF PRODUCT IN COMMERCE 889,132 units
DISTRIBUTION Nationwide

PRODUCT
a) ACEON®, (perindopril erbumine) Tablets, 2 mg, Bottles of 100, Rx Only, NDC 0032-1101-01,
b) ACEON®, (perindopril erbumine) Tablets, 4 mg, Bottles of 100, Rx Only, NDC 0032-1102-01,
c) ACEON®, (perindopril erbumine) Tablets, 8 mg, Bottles of 100, Rx Only, NDC 0032-1103-01,
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,
Manufacturer: Patheon – Cincinnati Operations, Cincinnati, OH.
REASON Presence of foreign substance; possibility of trace amounts of latex.
VOLUME OF PRODUCT IN COMMERCE 23,676 units
DISTRIBUTION Nationwide

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,
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
REASON Superpotent; Codeine Phosphate
VOLUME OF PRODUCT IN COMMERCE 17,044 bottles: 8967 Amide, 4188 MedPointe, 1825 Qualitest
DISTRIBUTION Nationwide

PRODUCT Hydrocortisone and Acetic Acid Otic Solution, USP, 10mL bottle, Rx only, NDC 0603-7039-39,
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
REASON Product fails specification for individual impurity.
VOLUME OF PRODUCT IN COMMERCE 52,259 units
DISTRIBUTION Nationwide

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
CODE Lot: C61131, exp. January 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Philadelphia, PA,
Manufacturer: Wyeth Pharmaceuticals, Inc., Rouses Point, NY.
REASON Failed USP dissolution test requirements
VOLUME OF PRODUCT IN COMMERCE 23,391 cartons of 3 dispensers
DISTRIBUTION Nationwide

WEEK ENDING JULY 12

PRODUCT Methadone HCI Oral Solution, 20mg,
CODE VistaPharm Lot # 135100 Whitney Lot # 5364 L
RECALLING FIRM/MANUFACTURER Whitney Labs, Ormond Beach, FL,
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

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,
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,
REASON Exceeded impurity specification.
VOLUME OF PRODUCT IN COMMERCE 18 lots
DISTRIBUTION Nationwide

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,
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,
REASON Exceeded impurity specification.
VOLUME OF PRODUCT IN COMMERCE 16 lots
DISTRIBUTION Nationwide

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, 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,
Manufacturer: IVAX Pharmaceuticals U.K., Ltd. Cheshire, UK.
REASON Failed pH Specification
VOLUME OF PRODUCT IN COMMERCE 2,123,450 vials
DISTRIBUTION LA, NC, NJ, NV, OH, and PR

WEEK ENDING JULY 19

PRODUCT Carbamazepine (Chewable) Tablets USP, 100mg, 100 tablets (10x10) unit dose blister packs,
CODE Lot # 073553, Exp. Date 7/31/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, Manufacturer: Taro Pharmaceuticals Industries U.S.A., Inc., Haifa Bay, Israel.
REASON Failed Dissolution Specification: 6 month stability timepoint.
VOLUME OF PRODUCT IN COMMERCE 1,078/100mg tablet blister packs
DISTRIBUTION Nationwide

PRODUCT Menopur (menotropins for injection, USP), 75 IU, carton containing: 5 single-dose vials of Menotropins for Injection, 5 single-dose vials of 0.9% Sodium Chloride Injection, and 5 Q-Cap Vial Adapters, Rx only. Outer carton NDC 55566-7501-2,8
CODE Lots: CB0613A-1, exp. 5/09 and CB0613A-2, exp 5/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ferring Pharmaceuticals, Inc., Parsippany, NJ, Manufacturer: Ferring GmbH, Kiel, Germany.
REASON Outer carton label contains a misprint of active ingredients. Label lists 75 IU of FSH twice when it should read 75 IU of FSH and 75 IU of LH.
VOLUME OF PRODUCT IN COMMERCE 15,955 cartons
DISTRIBUTION Nationwide

Roxane Laboratories, Inc. Initiates a Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension

Roxane Laboratories, Inc. announced today that it is conducting a nationwide recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Sodium Polystyrene Sulfonate Suspension is used to treat hyperkalemia (an elevated blood level of the electrolyte potassium).

A sample from product lot 856396A tested positive for a strain of yeast, which could potentially affect immunocompromised patients.

No other Roxane Laboratories, Inc. products or lots are impacted by this recall.

Information has been sent to Pharmacists alerting them of the details pertaining to this recall. As described in these recall communications, pharmacists who may have dispensed Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lots 856396A and 856693A are instructed to contact those patients to return the affected product to the pharmacist.

Pharmacists and wholesalers that have any Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lot 856396A or Lot 856693A have been instructed to discontinue distribution and use of these lots immediately and contact Capital Returns at 888.839.7837 for any questions regarding the recall returns. Requests for additional information should be referred to Roxane Laboratories Technical Product Information at 800.962.8364.

Advice For Patients Taking Sodium Polystyrene Sulfonate Suspension USP, 15 g/60 Ml Unit Dose Bottles

If your pharmacist has notified you that you may have received a bottle from one of the lots listed in this recall, please return your Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles to your pharmacist.

If you have NOT been notified by your pharmacist, please check your product to determine if it is from either of the two affected lots: Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lot 856396A Exp April 2010, or Lot 856693A Exp May 2010. If the product has either of these two lot numbers on the bottle, please contact your pharmacist for further instructions. This recall has been limited to these two specific lots.

WEEK ENDING JULY 26

PRODUCT Nifediac CC (Nifedipine) Extended-release Tablets USP, 90 mg, 100-tablet bottles, Rx only, NDC 0093-1023-01,
CODE Lot: 0703T33, exp. 2/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, North Wales, PA,
Manufacturer: Biovail Corporation, Steinbach Manitoba, Canada.
REASON Product does not meet dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE 9,240 bottles
DISTRIBUTION Nationwide

Jack Distribution, LLC. Issues a Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient

Jack Distribution, LLC, 1501 Green Road Unit C Pompano Beach, Florida 33064 and its wholesale distributors G & N works, Inc., and Devine Distribution, Inc., announced a nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. New lots of Rize 2 and Rose 4 her (not subject to this recall) will contain lot numbers beginning in "BL".

Jack Distribution, LLC, is conducting this recall after lab analysis of Rize 2 and Rose 4 Her samples of random lots found the product contains potentially harmful, undeclared ingredients. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

The company advises that any unused portions can be returned to the place of purchase for a full refund of purchase price. Jack Distribution will manufacture new lots of these products which are not subject to the recall. Those lot numbers will begin with "BL" and will begin to be sold shortly.