MARCH 2008

WEEK ENDING MARCH 1

PRODUCT
a) Zencore Tabs All Natural Male Enhancement Dietary Supplement, For Maximum
    Sexual Performance, packaged in a 2-count blister in a cardboard package, UPC Code
    for Individual Packet 859197001013 UPC Code for Display Box 859197001006;
b) Encore Tabs For Maximum Sexual Performance All Natural Male Enhancement
    Dietary Supplement, packaged in a 2-count blister in a cardboard package,
    UPC Code for Individual Packet 859197001013 UPC Code for Display Box
    859197001006; 
CODE
a) Lot Code: ZT500 (EXP 12/09), ZT010207 (EXP 12/09), ZTS100 (EXP 04/07);
b) Lot Code: 0C85
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bodee LLC, Century City, CA, 
Manufacturer: North West Marketing Co., Inc., Brea, CA. 
REASON Unapproved New Drug; product found to contain an undeclared analog of an active ingredient used in a FDA approved product to treat erectile dysfunction.
VOLUME OF PRODUCT IN COMMERCE 962,627 units. Each unit contains 2 capsules
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Heparin Sodium Injection USP, 1000 units/1 mL, Each mL contains heparin sodium
    1000 USP units Sodium Chloride 8.6 mg Benzyl Alcohol 0.01 in water for injection,
    in 10 mL Multiple Dose Vial for IV or SC USE (vial) and 25 x 10 mL Multiple Dose
    Vials for Intravenous or Subcutaneous Use. (pack), Rx only, NDC 0641244045
    (on pack) NDC 0641244041 (on vial), 
b) Heparin Sodium Injection USP 1000 USP units/1mL, 30 mL multi dose vial
    For IVor SC use (vial) and 25 x 30 mL multi dose vials For IVor SC use (pack),
    Rx only NDC 0641245045 (on pack); NDC 0641245041 (on vial),
CODE
a) Lots numbers: 107054, Exp 10/2009; 117085, Exp 11/2009;
b) Lot numbers: 047056, Exp. 10/2008; 097081; Exp 09/2009; 107024, Exp 10/2009; 107064, Exp. 10/2009; 107066; Exp. 10/2009; 107074, Exp. 10/2009; 107111, Exp 10/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, 
Manufacturer: Baxter Healthcare Corp., Cherry Hill, NJ. 
REASON Reports of Adverse Events; Increase of adverse patient reactions following the administration of certain lots of heparin at Dialysis Centers.
VOLUME OF PRODUCT IN COMMERCE 1,472,100 vials
DISTRIBUTION Nationwide, Germany, Guam and American Samoa

PRODUCT
a) INTERMUNE lnfergen Interferon alfacon-1, A recombinant consensus alpha
    interferon derived from E. coli, 9 mcg/0.3 mL, NDC 64116-039-06, For
    Subcutaneous Use Only Sterilie Solution - No preservatives, 6 - 0.3 mL Single-Use
    Vials, 
b) INTERMUNE lnfergen Interferon alfacon-1, A recombinant consensus alpha
    interferon derived from E. coli, 15 mcg/0.5mL, NDC 64116-031-06, For
    Subcutaneous Use Only Sterilie Solution - No preservatives, 6 - 0.5 mL Single-Use
    Vials, 
CODE
a) Lot Codes: 1) 0 P057622A (original Exp - 11/30/2007, extended Exp - 11/30/2008)
    2) P062263A (original Exp - 10/31/2007, extended Exp - 10/31/2008),
    3) P063704A (original Exp - 02/28/2008, extended Exp- 02/28/2009);
b) Lots: 1) P057613A (original Exp - 11/30/2007, extended Exp - 11/30/2008) - 4,088
    units distributed
    2) P057614A (original Exp - 11/30/2007, extended Exp - 11/30/2008) - 4,818 units
    3) P057615A (original Exp - 11/30/2007, extended Exp - 11/30/2008) - 5,416 units
    4) P057619A (original Exp - 12/30/2007, extended Exp - 12/30/2008) - 2,431 units
    5) P057620A (original Exp - 11/30/2007, extended Exp - 11/30/2008) - 5,760 units
    6) P063699A (original Exp - 12/30/2007, extended Exp - 12/30/2008) - 3,160 units
    7) P065733A (original Exp - 02/28/2008, extended Exp - 02/28/2009) - 44 units
    8) P065734A (original Exp - 02/29/2008, extended Exp - 02/29/2009) - 761 units
    9) P065737A (original Exp - 03/30/2008, extended Exp - 03/30/2009) - 1 unit
   10) P066895A (original Exp - 03/30/2008, extended Exp - 03/30/2009) - 1 unit
   11) P068076A (original Exp - 03/30/2008, extended Exp - 03/30/2009) - 8 units
   12) P071927A (original Exp - 11/30/2007, extended Exp - 11/30/2008) - 6,076 units
   13) P073211A (original Exp - 12/31/2007, extended Exp - 12/31/2008) - 1,033 units
   14) P073966A (original Exp - 03/30/2008, extended Exp - 03/30/2009) - 3,777 units
   15) P077786A (original Exp - 04/30/2008, extended Exp - 04/30/2009) - 5 units
   16) P077787A (original Exp - 04/30/2008, extended Exp - 04/30/2009) - 7 units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Valeant Pharmaceuticals International, Aliso Viejo, CA, 
Manufacturer: Amgen Inc., Thousand Oaks, CA. 
REASON Labeling; incorrect expiration date on vial. The cartons of some lots of Infergen were previously overstickered with an extended expiration date that added an additional 12 months of shelf-life to the product. The vial labels of the product in these lots, however, were not over-stickered with the extended expiration date.
VOLUME OF PRODUCT IN COMMERCE 45,089 units
DISTRIBUTION Nationwide

PRODUCT OPTIMUM OYSTER SHELL CALCIUM 250 mg with Vitamin D Dietary Supplement, 100 count bottles, Product code 6460-100-01, CODE Lot # 334830 Expiration 06/08
RECALLING FIRM/MANUFACTURER Magno Humphries Inc., Tigard, OR, 
REASON Presence of Foreign Tablet; acetominophen tablet was found.
VOLUME OF PRODUCT IN COMMERCE 154 bottles
DISTRIBUTION OR, WA, MO

PRODUCT
a) PREMPRO® (conjugated estrogens/medroxyprogesterone acetate tablets)
    0.3 mg/1.5 mg, Rx only, One carton contains 3 EZ-DIAL® Dispensers of 28 tablets
    each: NDC 0046-0938-09. One EZ-DIAL® Dispenser (NDC 0046-0938-08)
    contains 28 cream PREMPRO® Tablets containing 0.3 mg of the conjugated
    estrogens found in PREMARIN® and 1.5 mg of medroxyprogesterone acetate,
b) PREMPRO® (conjugated estrogen/medroxyprogesterone acetate tablets) 0.45
    mg/1.5 mg, Rx only, One carton contains 3 EZ-DIAL® Dispensers of 28 tablets
    each: NDC 0046-0937-09. One 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
a) Lots B77279 and B78846 (exp. June 2008);
b) Lot C13834 (exp. September 2008)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Philadelphia, PA,  
Manufacturer: Wyeth Pharmaceuticals, Inc., Rouses Point, NY. 
REASON Lot failed dissolution specification for NDA conjugated estrogens.
VOLUME OF PRODUCT IN COMMERCE 0.3/1.5 mg tablets: 49,488 cartons of 3 Dispensers; 0.45/1.5 mg tablets: 12,336 cartons of 3 Dispensers
DISTRIBUTION Nationwide

Palo Alto Labs Issues a Recall of Aspire36 and Aspire Lite, two Products Marketed as Dietary Supplements

Palo Alto Labs, 265 SW Port St. Lucie Blvd., Suite 252, Port St. Lucie, FL 34984, is conducting a nationwide recall of the company's supplement products sold under the name Aspire36 and Aspire Lite. Palo Alto Labs is conducting this recall after lab analysis found that the products contained Aildenafil in trace amounts and Dimethyl sildenafil thione (sulfoaildenafil) a purported analog of Sildenafil,a drug used as treatment for male Erectile Dysfunction (ED).

Aspire36 and Aspire Lite are sold nationwide. The products are sold as a blister pack containing one liquid capsule or a bottle containing either three (3) or twelve (12) liquid capsules.

Consumers who have Aspire36 and Aspire Lite in their possession should stop using them immediately. In the event of any adverse side effects due to the consumption of these products, consumers should contact a physician right away. 

The Company is advising consumers to return any unused Aspire36 and Aspire Lite, for a refund of the full purchase price, to the retail location from which it was purchased or to the Company directly if it was purchased from the Company as a part of its Direct Response Program. 

Consumers can call 1-(877)240-3340 for instructions on the return and refund process.

Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products

Baxter International Inc. is recalling of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products.

Baxter's recall will now include the remaining lots of those products and heparin sodium injection 5000 units/mL 10mL multi-dose vials, heparin sodium injection 10,000 units/mL 4mL multi-dose vials, heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, and 10,000 USP units/mL single-dose vials, and all HEP-LOCK and HEP-LOCK U/P, 10 USP units/mL and 100 USP units/mL vials, both preserved and preservative-free.

This recall does not involve Baxter's heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.

Customers have been instructed to discontinue use and segregate the recalled product from the rest of their inventory. Customers should then contact Baxter to arrange for return and replacement product. Customers with recalled product purchased indirectly should contact their wholesaler or distributor for return and replacement product. 

Customers with questions may contact the Center for One Baxter at 1-800-4-BAXTER (1-800-422-9837). Representatives will be available twenty-four hours a day, seven days a week.

Actavis Recalls Remaining Fentanyl Patches

Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, today announced that  it is recalling  from wholesalers and pharmacies of all lots of Fentanyl transdermal system CII patches sold in the United States.

This recall is an expansion of the Company's initial recall of fourteen lots of Fentanyl transdermal patches announced on February 17, 2008. That recall was due to the identification of a possible fold-over defect present in the product that potentially could cause leakage of the fentanyl gel. The remaining lots of Fentanyl transdermal system patches are being recalled as a precautionary measure because Actavis lacks assurance that all patches are free from defects.

All of the recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States.

Please note: Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches may be labelled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names:

Actavis Fentanyl Transdermal System, 25 mcg/hr.    NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr.    NDC 67767-121-18.
Actavis Fentanyl Transdermal System, 75 mcg/hr.    NDC 67767-122-18.
Actavis Fentanyl Transdermal System, 100 mcg/hr.  NDC 67767-123-18.

The lots covered by this recall have expiration dates between May 2009 and December 2009. Anyone who has fentanyl patches labelled with an Abrika or Actavis label should check them for these expiration dates.

Anyone with Actavis Fentanyl transdermal system patches with the lot numbers listed on the schedule, should call 1 877 422 7452.

Patients using fentanyl patches who have medical questions should contact their health-care providers.

Fentanyl transdermal system is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.

Schedule

WEEK ENDING MARCH 8

PRODUCT Alprazolam Extended-Release Tablets, 3mg, Rx only, packaged in 60 count plastic (HDPE) bottles, NDC 0185-0198-60, Catalog Number: 0198-60, 
CODE Lot number: MK070099
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Princeton, NJ, 
Manufacturer: Sandoz, Inc., Wilson, NC. 
REASON Failed Dissolution Specification (6 month stability)
VOLUME OF PRODUCT IN COMMERCE 1,566 bottles (60 count)
DISTRIBUTION Nationwide

WEEK ENDING MARCH 15

PRODUCT
a) Major Infants' Gas Relief Drops, (Active ingredient in each 0.6 mL) Simethicone, 40mg, 1 Fl. Oz. (30mL) bottles with Plastic Dropper Enclosed, NDC - Major 094-5067-30; Also labeled as: 

b) Tri-Med Gas Relief Drops, (Active ingredient in each 0.6 mL) Simethicone 40 mg, 1 fl. oz (30 mL) with Plastic Dropper Enclosed, NDC Tri-Med: 55654-009-01. Suitable for Infant Use,
CODE Lot E617 Expiration Date: 4/09
RECALLING FIRM/MANUFACTURER Tri-Med Laboratories Inc., Somerset, NJ,
REASON Microbial Contamination of Non Sterile Product; Yeast.
VOLUME OF PRODUCT IN COMMERCE
a) 1440 bottles; b) 10,800 bottles
DISTRIBUTION MI, OH, FL, IL, NJ and IN

PRODUCT
a) Duragesic® 25 mcg/h (Fentanyl Transdermal System), Each transdermal system contains; 2.5mg fentanyl and 0.1mL alcohol USP, supplied in boxes of 5 systems, Rx only,
b) Fentanyl Transdermal System 25 mcg/h, Each transdemal system contains: 2.5mg fentanyl and 0.1 mL alcohol USP, supplied in boxes of 5, Rx only, CODE All lot codes
RECALLING FIRM/MANUFACTURER GPSG - Unit of ALZA Corp., Vacaville, CA, 
REASON Defective Delivery System; drug reservoir containing API concentrated gel is leaking due to improper cutting of patch delivery system.
VOLUME OF PRODUCT IN COMMERCE 3,577,458 cartons
DISTRIBUTION Nationwide and Canada

PRODUCT Megestrol Acetate Oral Suspension USP 40 mg/ml, sold in a 240 ml bottle (8 fl. oz.), Rx only. NDC number is 0093-9634-87,
CODE Lot number 26784 exp 2/2009
RECALLING FIRM/MANUFACTURER TEVA Pharmaceuticals USA, Inc., Sellersville, PA, 
REASON Subpotent; megestrol
VOLUME OF PRODUCT IN COMMERCE 3,624 bottles
DISTRIBUTION Nationwide

WEEK ENDING MARCH 22

PRODUCT Carbon Dioxide USP in either 50 pound syphon cylinders, E size cylinders, or 50 pound cylinders, 
CODE All cylinders from US Welding in inventory as of 02/21/2008
RECALLING FIRM/MANUFACTURER United States Welding, Incorporated, Denver, CO. 
REASON cGMP Deviation; Cylinders were not properly re-qualified prior to filling with Carbon Dioxide USP.
VOLUME OF PRODUCT IN COMMERCE 17/50 pound syphon cylinders, 308/E size cylinders, 214/50 pound cylinders
DISTRIBUTION CO, ID, KS, NE, UT, and WY

PRODUCT Caraco brand Metformin HCl tablets, USP, 1000 mg, in bottles of 100 (NDC 57664-474-88), 500 (NDC 57664-474-13) and 1000 (NDC 57664-474-18), Rx; 
CODE Lots 71810, 72015, 72017, 72022, 72080, 72082 and 72083
RECALLING FIRM/MANUFACTURER Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI
REASON Tablet Weight; Some tablets may be undersized or oversized, which will result in the patient not receiving the expected dose.
VOLUME OF PRODUCT IN COMMERCE 22,156 bottles
DISTRIBUTION Nationwide

PRODUCT Sinus & Allergy Nasal Spray, Homeopathic, 0.8 fl. oz; NDC 59853-708-11, 
CODE Lot #: 28188W
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nutraceutical Corporation, Park City, UT, 
Manufacturer: Botanical Laboratories, Inc., Ferndale, WA. 
REASON Superpotent; benzalkonium chloride
VOLUME OF PRODUCT IN COMMERCE 8,840 bottles
DISTRIBUTION Nationwide

PRODUCT
a) Citracal® Prenatal Rx, Prenatal Prescription multi-vitamin and multi-mineral tablets, 100 oral tablets, Rx only, NDC 0178-0852-01; Item #085201; 
b) Citracal® Prenatal + DHA, Rx Prenatal Vitamin Tablet and 250mg DHA Capsule;, Six 5-day Blister Packs per package, Rx only, NDC 0178-2300-30; Item #230030;
c) Citracal® Prenatal 90 + DHA, Rx Prenatal Vitamin Tablet and 250mg DHA Capsule; Six 5-day Blister Packs per package, contains 90mg Carbonyl Iron, Rx only; NDC 0178-4200-30; Item #420030, CODE
a) Lot #7A078, 7A079, 7B062, 7D045 and 7E047;
b) Lot #7A079, 7A118, 7B060, 7B061, 7C097, 7C098, 7D043, 7D044, 7E046, 7E047, 7G010A, and 7G011A;
c) Lot #7A041, 7B033, 7D042 and 7D042A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mission Pharmacal Co., San Antonio, TX, 
Manufacturer: Mission Pharmacal Co., Boerne, TX.
REASON Potency of Vitamin A is not assured through labeled expiration.
VOLUME OF PRODUCT IN COMMERCE 14,329,007 units
DISTRIBUTION Nationwide

PRODUCT Breckenridge Pharmaceutical, Inc. Sulfatol Gel (Sodium Sulfacetamide 10% and Sulfur 5%) Net Wt. 1.5 fl. oz (45 ml, Rx. Contains100 mg of sodium sulfacetamide and 5% of sulfur in an emulsion base containing Urea 10%. NDC 51991-172-45, 
CODE Lot #: 60608E05/08
RECALLING FIRM/MANUFACTURER Sheffield Laboratories, Division of Faria Limited LLC, New London, CT
REASON Subpotent; sodium sulfacetamide
VOLUME OF PRODUCT IN COMMERCE 23,256 tubes
DISTRIBUTION CT

American Health Packaging Announces a Recall of Approximately 1,400 Units of Heparin Sodium Vial Products as Part of Broader Baxter Recall

American Health Packaging (AHP), a subsidiary of AmerisourceBergen Corporation (NYSE:ABC), is recalling 1,421 units (25 vials per unit) of 10000 USP units/ml heparin sodium injection 1ml vials as part of the broader February 29, 2008 recall of Heparin products made by Baxter Healthcare Corporation. The vials were manufactured by Baxter and then placed by AHP into individually labeled bags for use in pharmacy automation equipment. The AHP packages where sold to five hospitals in Georgia and California, all of whom were notified of the recall earlier this month. Baxter Healthcare will reimburse AHP for the recalled product.

The recalled products are APS HEPARIN 10MU/ML (10000 USP units/ml) 1ml SDV 25UD (bag) NDC # 00641-0410-25, lot numbers 074155, 073089, 073391, 073613, 070095A, 073712, 072907, 073454, 070095D and APS HEPARIN SDV 10MU (10000 USP units/ml) 1ml 25UD (box and rod) NDC # 00641-0410-25, lot numbers 070095B, 070095C, 068286, 067755. AHP instructed customers to return any and all of these product lots remaining in inventory.

This recall was initiated due to the Baxter Healthcare’s recall which stated, "…voluntary recall of Heparin Sodium Injection to include all lots of single and multi-dose vial products, due to an increase in reports of adverse patient reactions including abdominal pain, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnia, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, including profound and refractory hypotension, increased lacrimation, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, paresthesia (oral), pharyngeal adema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. The reports of profound and refractory hypotension usually occur with the first few minutes of bolus administration."

Heath care professionals with questions about the AHP packages should contact Richard J. Augustine at 1-800-707-4621. To report adverse drug events or for information on the Baxter Healthcare recall of all Heparin Sodium Injection products, please contact Baxter Healthcare at 1-800-667-0959.

B. Braun’s Supplier Recall of Heparin API Prompts Recall of Heparin Solutions

  B. Braun Medical Inc. was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The recall affects the following 23 Finished Product (FP) lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada.

B. Braun Medical Inc. began recalling the lots on March 21, 2008 as a precautionary measure. This product recall was initiated due to a notification received from the supplier, Scientific Protein Laboratories (SPL), disclosing that one lot of Heparin Sodium, USP Active Pharmaceutical Ingredient acquired by B. Braun Medical Inc. has a heparin-like contaminant. 

Customers who have product in their possession from the recalled product lots should discontinue use immediately.  Patients reporting any problems that may be related to the use of this product should be advised to contact a physician. 

Customers may contact B. Braun Medical Inc. Customer Support Department at (800) 227-2862 for U.S. and (800) 624-2920 for Canada, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for replacement product.

WEEK ENDING MARCH 29

PRODUCT Wellbutrin XL® (bupropion hydrochloride extended release tablets) 300 mg, 30 tablet bottles, Rx only, NDC 0173-0731-01, 
CODE Lot number P08A011, Expiration May 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: GlaxoSmithKline Inc., Zebulon, NC, 
Manufacturer: Biovail Corporation, Steinbach Manitoba, Canada. REASON Presence of foreign material was found embedded within the tablets
VOLUME OF PRODUCT IN COMMERCE 24561 bottles
DISTRIBUTION Nationwide

PRODUCT
a) Sore Relief First Aid Antiseptic (Benzethonium Chloride 0.2%) and Topical Analgesic (Lidocaine 2.0%), Net Wt. 20g each, For Professional Use Only, NDC 65123-749-01, 
b) Durable Closure First Aid Antiseptic (Benzethonium Chloride 0.2%); Net Wt 20g each, For Professional Use Only, NDC 65123-747-01, 
CODE
a) Lot #: 749.013, Exp. 03/08 and 749.015, Exp. 04/09;
b) Lot #: 749.011, Exp. 01/09
RECALLING FIRM/MANUFACTURER Activ Group, Southlake, TX
REASON Misbranded; active ingredients in the formulation of this OTC drug are labeled as inactive on the package labeling and drug is promoted for uses not described on package label.
VOLUME OF PRODUCT IN COMMERCE 1,427/20g jars
DISTRIBUTION Nationwide