MARCH 2007

WEEK ENDING MARCH 3

PRODUCT
a) Levothyroxine Sodium Tablets USP, 25 mcg (0.025 mg), 100 and 1000 tablet bottles, Rx only,
b) Levothyroxine Sodium Tablets, USP, 50 mcg (0.050mg), 100 and 1000 tablet bottles, Rx only, 
c) Levothyroxine Sodium Tablets, USP, 75 mcg (0.075mg), 100 and 1000 tablet bottles, Rx only, 
d) Levothyroxine Sodium Tablets, USP, 88 mcg (0.088mg), 100 tablet bottles,
Rx only,
e) Levothyroxine Sodium Tablets, USP, 100 mcg (0.1mg), 100 and 1000 tablet bottles, Rx only, 
f) Levothyroxine Sodium Tablets, USP, 112 mcg (0.112mg), 100 tablet bottles,
Rx only,
g) Levothyroxine Sodium Tablets, USP, 125 mcg (0.125mg), 100 tablet bottles,
Rx only, 
h) Levothyroxine Sodium Tablets, USP, 137 mcg (0.137mg), 100 tablet bottles,
Rx only, 
i) Levothyroxine Sodium Tablets, USP, 150 mcg (0.150mg), 100 and 1000 tablet bottles, Rx only, 
j) Levothyroxine Sodium Tablets, USP, 175 mcg (0.175mg), 100 tablet bottles,
Rx only, 
k) Levothyroxine Sodium Tablets, USP, 200 mcg (0.200mg), 100 tablet bottles,
Rx only, 
l) Levothyroxine Sodium Tablets, USP, 300 mcg (0.300mg), 100 tablet bottles,
Rx only, 
CODE
a) C05T2671A 05T2670 Exp Feb. 07, C06T0311A2 06T0020 Exp Jul 07,
C06T0311A3 06T0030 Exp Jul 07, C06T0321A3 06T0090 Exp Jul 07,
C06T0341A2 06T2630 Exp Aug 07, C06T1051A6 06T6370 Exp Sep 07,
C06T0881A1 06T4820 Exp Sep 07, C06T0341A1 06T2620 Exp Aug 07,
C06T0341A4 06T2650 Exp Aug 07, C06T0341A5 06T2660 Exp Aug 07,
C06T0341A6 06T2670 Exp Aug 07, C06T0361A1 06T2720 Exp Aug 07,
C06T0361A2 06T2730 Exp Aug 07, C06T0361A3 06T2740 Exp Aug 07,
C06T035IA4 06T2680 Aug 07, C06T0351A2 06T2700 Exp Aug 07,
C06T0351A1 06T2690 Exp Aug 07, C06T0871A1 06T4270 Exp Sept 07,
C06T0871A2 06T4280 Exp Sep07, C06T0871A5 06T4800 Exp Sep 07,
C06T0871A6 06T481O Exp Sep 07, C06Tl041A1 06T6280 Exp Sep 07,
C06Tl041A2 06T6300 Exp Sep 07, C06Tl041A3 06T6310 Exp Sep 07,
C06T1061A3 06T6400 Exp Sep 07, C06T1051A1 06T6320 Exp Sep 07,
C06Tl051A2 06T6330 Exp Sep 07, C06T1051A3 06T6340 Exp Sep 07,
C06T0881A2 06T6230 Exp Sep 07, C06T0881A4 06T6250 Exp Sep 07,
C06T0881A5 06T6260 Exp Sep 07, C06T0881A6 06T6270 Exp Sep 07,
C06T1071A4 06T6450 Exp Oct 07, C06Tl071A6 06T6470 Exp Oct 07,
C06Tl081A3 06T6500 Exp Oct 07, C06T0351A3 06T271O Exp Aug 07,
C06T0871A3 06T4290 Exp Sep 07, C06T0871A4 06T4300 Exp Sep 07,
C06T0881A3 06T6240 Exp Sep 07, C04T1641A 04T12200 Exp Dec 06,
C04T1641A 04T12210 Exp Dec 06, C04T1661A 04T12300 Exp Dec 06;
b) C06T0211A1 05T2140 Exp Jul 07, C06T0221A2 06T2030 Exp Jul 07,
C06T0231A1 06T2040 Exp Jul 07, 06T4831A 06T4830 Exp Sep 07,
C06Tl111A1 06T651O Exp Oct 07, C06T0471A1 06T2770 Exp Aug 07,
06T2811A 06T2810 Exp Aug 07, C06T0461A2 06T2760 Exp Aug 07,
06T4351A 06T4350 Exp Sep 07, C06T0481A1 06T2790 Exp Aug 07,
C06T0211A2 06T2150 Exp Jul 07, C06T0241A2 06T2180 Exp Jul 07,
C06T0241A1 06T2170 Exp Jul 07, C06T0231A2 06T2160 Exp Jul 07,
C06T0121A1 06T2210 Exp Jul 07, C06T0121A2 06T2220 Exp Jul 07,
C06T0131A1 06T219O Exp Jul 07, 06T2231A 06T2230 Exp Jul 07,
C06T0461A1 06T2750 Aug 07, C06T0471A2 06T2780 Exp Aug 07,
C06T0481A2 06T2800 Exp Aug 07, C06T0491A1 06T2820 Exp Aug 07,
06T4311A 06T431O Exp Sep 07, C06T0791A1 06T4320 Exp Sep 07,
C06T0791A2 06T4340 Exp Sep 07, 05T3441A Exp Apr 07,
C05T0071A4 Exp May 07, 05T9061A Exp Jul 07;
c) C04T2511A 04T16040 Exp Feb 07, C05T1011A1 05T11320 Exp Feb 07,
C05T1011A2 05T11340 Exp Feb 07, C05T1011A3 05T11350 Exp Feb 07,
C05T1011A4 05T11360 Exp Feb 07, C05T1011A5 05T11370 Exp Feb 07,
C05T1031A4 05T11470 Exp Feb 07, C05T1031A4 05T11480 Exp Feb 07,
C05T1041A3 05T11520 Exp Feb 07, C05T1051A1 05T11560 Exp Feb 07,
C05T0571A5 05T10870 Exp Dec 06, C05T0571A1 05T9080 Exp Dec 06,
05T7491A 05T7491 Exp May 07, C05T1021A2 05T11390 Exp Feb 07,
C05T1021A4 05T11410 Exp Feb 07, C05T1381A2 05T13890 Exp Mar 07,
C05T1381A5 05T13920 Exp Mar 07, C05T1391A1 05T13940 Exp Mar 07,
C05T1391A4 05T13970 Exp Mar 07, C05T11381A6 05T13930 Exp Mar 07,
C05T1381A1 05T11710 Exp Mar 07, C05T1021A3 05T11400 Exp Mar 07,
C05T1041A1 05T11500 Exp Feb 07, C05T1041A2 05T11510 Exp Mar 07,
C05T1041A4 05T11530 Exp Mar 07, C05T1041A5 05T11540 Exp Mar 07,
C05T1041A6 05T11550 Exp Mar 07, C05T1051A2 05T11570 Exp Mar 07,
C05T10571A2 05T9090 Exp Mar 07, C05T10571A3 05T9760 Exp Dec 06,
C05T0571A4 05T10860 Exp Dec 06, 05T5801A 05T5800 Exp May 07,
C05T0231A2 05T6940 Exp May 07, 05T5661A Exp Apr 07, 05T7491A Exp May 07;
d) C05T0841A1 05T7080 Exp Mav 07;
e) C04T2291A Exp Jan 07;
f) C04T2251A Exp. Feb 07;
g) C05T0431A Exp Feb 07;
h) C05T2261A2, C05T2261A3;
i) C05T1411A3 05T14130 Exp Mar 07, C05T0941A Exp Apr 07;
j) 05T3211A 05T3210 Exp Mar 07, C05T0681A1 Exp May 07;
k) C05T0131A1 05T7320 Exp Mar 07, C05T0801A1 05T11200 Exp Jul 07;
l) 05T9391A Exp Jul 07, 04T11911A Exp Nov 06
RECALLING FIRM/MANUFACTURER
Recalling Firm: ALARA Pharmaceutical Corp, Caguas, PR
Manufacturer: Mova Pharmaceutical Corp, Caguas, PR. 
REASON Subpotent
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide and PR

PRODUCT
a) Thyro-Tab 0.025 mg, packaged in 150,000-tablet bulk drums intended
for repackaging,
b) Levothroid (levothyroxine sodium tablets, USP), 25 mcg, packaged in
100- and 1,000-count bottles, Rx only, NDC 0456-1320-01 (100-ct.) and
NDC 0456-1320-00 (1,000-ct.), 
CODE
a) Lot #HA08306, Exp. April 2007;
b) Lot 050604 (100 ct.) and Lot 050605 (1,000-ct.), Exp. April 2007
RECALLING FIRM/MANUFACTURER Lloyd Inc of Iowa, Shenandoah, IA
REASON Subpotent (6-month stability)
VOLUME OF PRODUCT IN COMMERCE 1,922,958 bulk tablets; 13,286/100-tablet bottles and 544/1,000-tablet bottles
DISTRIBUTION Nationwide

PRODUCT Tizanidine HCl Tablets, 2 mg, packaged in 150 tablet plastic bottles, Rx only, 
CODE Lot 9694 Exp September 2007
RECALLING FIRM/MANUFACTURER Alphapharm Pty, Ltd. Carole Park, Australia,
REASON Failed Dissolution Test Requirements
VOLUME OF PRODUCT IN COMMERCE 48 bottles/150 count
DISTRIBUTION CO and TN

PRODUCT Dacarbazine for Injection USP, 200 mg, prepared as the citrate salt, 1 vial - sterile, Rx only, Cytotoxic Agent, For Intravenous Use Only, NDC 61703-327-22, 
CODE Lot # S012223, Expiration 03/31/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mayne Pharma (USA) Inc., Paramus, NJ
Manufacturer: Mayne Pharma Group, Victoria, Australia. 
REASON Discoloration due to impurity (3 and 6 month stability time points)
VOLUME OF PRODUCT IN COMMERCE 3,391 vials
DISTRIBUTION MI, SC, NY, PA, FL, NJ, AL, OH, CA, CT and PR

Gebauer Company Announces a Recall of Salivart® Oral Moisturizer

Gebauer Company, a 107-year-old medical device manufacturer and marketer,  announced a nationwide recall of certain lots of its Salivart Oral Moisturizer, product number 0386-0009-75. These lots may contain some units that do not meet the Company's internal specification for aerobic microorganisms and mold.

Lot numbers and expiration dates are located on the bottom of the product can. The recalled product lots are:

Customers who believe they are in possession of the recalled product should stop using the product and dispose of it immediately in their regular trash.

Should customers require additional information, they are to contact Gebauer Company Customer Service at (800) 321-9348.

WEEK ENDING MARCH 10

Bausch & Lomb Initiates Recall of Twelve Lots of ReNu MultiPlus Solutions 

Bausch & Lomb (NYSE/BOL) has initiated a recall from distribution centers and retail shelves in the United States and specific other countries of 12 lots of ReNu MultiPlus lens care solution made at its plant in Greenville, SC because they contain an elevated level of trace iron. This may result in discoloration of the solution in some bottles, and the shelf life of the product may be shortened to less than its two-year expiration date, due to a potential loss of effectiveness over time. .

About a million bottles of solution from nine of the 12 lots were originally distributed in the United States. Product from the 12 affected lots was also distributed in Canada, Latin America, Korea and Taiwan, where it is also being recalled.

If consumers notice that their lens care solution appears to be discolored, they should discard it, as it may be losing effectiveness. The recalled lots all carry the expiration date "2008 – 03" on the bottle. Consumers who have bottles from the lot numbers listed below should check the Company's web site at www.bausch.com/productrecall or call the consumer affairs line (1-866-259-8255) to arrange for a replacement.

LOT NUMBERS SUBJECT TO RECALL: GC6030 – GC6037 – GC6038 – GC6045 – GC6048 – GC6052 – GC6061 – GC6063 – GC6072 – GC6073 – GC6080 – GC6085

WEEK ENDING MARCH 17

PRODUCT Care340B Glyburide Tablets, 5 mg, 30 tablet bottles, Rx only, Product # CC528, NDC 66336-938, 
CODE Lots: A00330, exp. 8/07 and A00458, exp. 8/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dispensing Solutions, Inc, Santa Ana, CA,
Manufacturer: Novopharm Ltd, Scarborough, Ontario Canada. 
REASON Ingredient statement incorrectly reports that each tablet contains 5 mg Glipizide instead of 5 mg Glyburide.
VOLUME OF PRODUCT IN COMMERCE 150/30-tablet bottles
DISTRIBUTION CA, and AK

Barodon SF Issues A Recall of V.MAX, a Product Marketed as Dietary Supplement

  Barodon SF, 2823 W. 8TH St, Los Angeles, CA 90005, announced a recall of the company's supplement product sold under the name V.MAX. Barodon SF is conducting this recall after being informed  that lab analysis of V.MAX samples found the product contains aminotadalafil. Aminotadalafil is an analog of Tadalafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). This poses a threat to consumers because aminotadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. 

V.MAX is sold nationwide and in the past has also been exported to South Korea and Japan. V.MAX is packaged with an outer box containing three smaller inner boxes each containing five capsules making it a total of 15 capsules per unit.

Consumers who have V.MAX in their possession should stop use immediately. In the event of any adverse side effects due to its consumption, consumers should contact a physician right away. Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

The company advises that any unused portion be returned to Barodon SF, Inc. for a full purchase price refund by calling (213) 381-8272 for instructions on the return and refund process.

Cosmos Trading, Inc. Issues Recall of Rhino Max (Rhino V Max), a Product Marketed as a Dietary Supplement

Cosmos Trading, Inc., 1543 Olympic Blvd, Suite# 419 Los Angeles, CA 90015, announced it is conducting a recall of the Company's supplement product sold under the name Rhino Max (Rhino V Max).Lab analysis found the product contains Aminotadalafil. Aminotadalafil is an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED), making Rhino Max (Rhino V Max) an unapproved drug. FDA advised that this poses a threat to consumers because Aminotadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. 

The recalled Rhino Max (Rhino V Max) is sold in 5-tablet boxes or 15-tablet boxes. The product label does not warn consumers with high blood pressure not to ingest the product. Also, it does not state it contains Aminotadalafil.

Consumers who have Rhino Max (Rhino V Max) in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product. The public is encouraged to submit a report of any serious adverse events that occur with the use of Rhino Max (Rhino V Max) to the FDA's MedWatch Adverse Event Reporting program online [at http://www.fda.gov/medwatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from http://www.fda.gov/medwatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

Consumers should return any unused Aminotadalafil, for a refund of the full purchase price or price for the unused portion, to the retail location where it was purchased or to Cosmos Trading directly at (213) 598-6699 to receive further instructions for returning the product or with any questions.

WEEK ENDING MARCH 24

PRODUCT
a) Pain Reliever PM, oral caplet, active ingredients: Acetaminophen 500 mg,
Diphenhydramine HCl 25 mg, packaged under two labels: 

1) MHL Pain Reliever PM, 100 caplet bottles, distributed by Magno-Humphries Labs;
2) MEDICAP PHARMACY Pain Reliever PM, 50 caplet bottles,

b) Children's non-aspirin pain and fever reliever, oral liquid, active ingredient:
Acetaminophen 160 mg, cherry flavor, 4 fluid ounce bottles, packaged under
two labels: 

1) MHL Children's Non-Aspirin Oral Suspension, distributed by
Magno-Humphries Labs; 

2) BI-MART Children's Non-Aspirin Pain Relief Liquid, distributed by BI-MART,

c) Extra strength pain reliever, oral tablet, active ingredients: Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg, packed under 2 labels:
MHL Extraprin Pain Reliever/Pain Reliever Aid, Extra Strength, 100 & 200
tablet bottles, distributed by Magno-Humphries Labs, Tigard, OR;
BI-MART Extra Strength Combination Pain Reliever, 250 tablet bottles,
distributed by BI-MART,

d) Ibuprofen, oral tablets, 200 mg, packed under 3 labels:
1) MHL Ibuprofen, 50 & 100 tablet bottles, distributed by Magno-Humphries Lab, 

2) Aurora Pharmacy Ibuprofen, 100 tablet bottles, distributed by Aurora Pharmacy, Inc.
3) AARP Pharmacy Services Ibuprofen, 100 tablet bottles, distributed by United HealthCare Products, LLC, 

e) Cough suppressant/expectorant, oral liquid, 8 fluid ounce bottles, active ingredients: Dextromethorphan HBr, 10 mg, Guaifenesin, 100 mg, packed under two labels: MHL Tussin DM Cough Suppressant/Expectorant, distributed by Magno-Humphries Labs, BI-MART Tussin DM Cough Suppressant/Expectorant, distributed by BI-MART,

f) Night time cold medicine, oral liquid, active ingredients: Acetaminophen 500 mg, Dextromethorphan hydrobromide 15 mg, Doxylamine succinate 6.25 mg, packed under 2 labels: 

1) MHL Nite Time New Pseudoephedrine-free Formula Regular Cold
Medicine, 6 fluid ounce bottles, distributed by Magno-Humphries Labs;
2) BI-MART Night Time Cold Medicine New Pseudoephedrine-Free Formula,
6 & 10 fluid ounce bottles, 

g) Night time cold medicine cherry flavored, oral liquid, active ingredients:
Acetaminophen 500 mg, Dextromethorphan hydrobromide 15 mg, Doxylamine
succinate 6.25 mg, packed under 2 labels:
1) MHL Nite Time New Pseudoephedrine-free Formula Cherry Cold Medicine,
6 fluid ounce bottles, distributed by Magno-Humphries Labs;
2) BI-MART Cherry Flavor Night Time Cold Medicine New Pseudoephedrine-Free Formula, 6 & 10 fluid ounce bottles, distributed by BI-MART, 

h) BI-MART Day Time Cold Medicine, New Pseudoephedrine-Free Formula, oral liquid, active ingredients: Acetaminophen 325 mg, Dextromethorphan hydrobromide 15 mg, 6 fluid ounce bottles, 

i) MHL Sleep-Tabs Nighttime Sleeping Aid, oral tablet, active ingredient: Diphenhydramine hydrochloride 25 mg, 100 tablet bottles

j) MHL Diphenhydramine hydrochloride Nighttime Sleeping Aid, 50 mg, oral tablet, 50 tablet bottle, 
k) Medicap Pharmacy Aler-Caps, oral capsule, active ingredient: Diphenhydramine hydrochloride 25 mg,100 capsule bottles

CODE
a) 

1) Lots: 334900, exp. 02/08; 335267, exp. 04/08; 

2) Lot 333365, exp. 11/07;
b) 

1) Lot 334558, exp. 02/08; 

2) Lots: 334439, exp. 02/08, 334980, exp. 02/08;
c) 

1) Lots: 334735, exp. 05/08; 334890, exp. 5/08;
2) 334888, exp. 05/08; 334994, exp. 05/08, 335121, exp. 05/08;
d) 

1) Lots: 334842, exp. 06/08; 335042, exp. 06/08;
2) 334985, exp. 06/08; 335185, exp. 06/08;
3) 334761, exp. 06/08; 335062, exp. 06/08;
e) 

1) Lot 334767, exp. 02/08;
2) Lots: 334445, exp. 02/08; 334624, exp. 02/08; 334646, exp. 02/08;
334749, exp. 02/08; 334846, exp. 02/08; 335115, exp. 02/08;
335228, exp. 02/08; 335283, exp. 02/08;
f) 

1) Lot 334679, exp. 05/08;
2) Lots: 335347, exp. 09/08; 334417, exp. 01/08; 334625, exp. 05/08;
334721, exp. 05/08; 335020, exp. 05/08; 335347, exp. 09/08;
334418, exp. 01/08; 334656, exp. 01/08; 334720, 01/08;
335005, exp. 01/08; 335348, exp. 01/08;
g) 

1) Lot 335074, exp. 07/08;
2) Lots: 334446, exp. 07/08; 335272, exp. 07/08; 334419, exp. 01/08;
334647, exp. 01/08; 335006, exp. 01/08; 335116, exp. 01/08;
h) Lots: 334420, exp. 02/08; 334748, exp. 02/08; 334869, exp. 02/08;
i) Lots: 335208, exp. 06/09; 335304, exp. 06/09;
j) Lots: 334764, exp. 07/08; 335114, exp. 07/08;
k) Lots: 333512, exp. 01/08; 334067, exp. 01/08; 334080, exp. 01/08
RECALLING FIRM/MANUFACTURER Magno Humphries Inc., Tigard, OR., 
REASON Peel-back labels may delaminate so that drug use information may not be readable.
VOLUME OF PRODUCT IN COMMERCE 34,787 bottles
DISTRIBUTION AZ, IL, ND, NY, NJ, NV, MO, OH, OR, TX, WA, and WI

PRODUCT Ricola Lemon Mint Herb Throat Drops, Sugar Free, Active Ingredient: Menthol 1.1 mg, 19 drops per bag, 
CODE Lots: U064737025J and U064737031J
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ricola Inc, Morris Plains, NJ, 
Manufacturer: Ricola Ag, Laufen, Switzerland. 
REASON Ricola bags labeled as Sugar Free Lemon Mint Herb Throat Drops may contain Ricola Natural Honey Lemon with Echinacea Cough Suppressant Throat Drops which contain 2.2 g of sugar in each throat drop.
VOLUME OF PRODUCT IN COMMERCE 6,048 bags
DISTRIBUTION Nationwide

FiberChoice Plus Multivitamins 

GlaxoSmithKline (GSK) Consumer Healthcare, marketers of FiberChoice® fiber supplement is recalling the newest variant of FiberChoice® plus Multivitamins fiber supplement. This recall affects 90 count (16oz.) plastic bottles with the UPC #5714500581, which is located on the side of the bottle in black lettering. One of the following lot numbers appears on the bottom of the bottle in black lettering:

This recall was initiated after we discovered fish gelatin, a known allergen, contained in one of the raw materials of the product, which was not declared on the product label for the multivitamins being recalled. The fish gelatin consists of the following species of fish: cod, pollock, hake, cusk, haddock, redfish, sole, and flounder.

PLEASE NOTE: GSK Consumer Healthcare estimates the recall involves approximately 144,000 plastic bottles. This product was recently shipped to major retailers, including food and drug and mass merchandisers beginning on January 15, 2007.

Consumers who have purchased the new FiberChoice plus Multivitamins fiber supplement should return it to the retail store where it was purchased for a full refund. Consumers with questions about the product or this recall are encouraged to call GlaxoSmithKline Consumer Healthcare toll-free at 1-800-819-0681.

Woodridge Labs Recalls Certain DermaFreeze365 Products 

Woodridge Labs, Inc., has recalled all lots of its DermaFreeze365™ Instant Line Relaxing Formula (UPC Codes 6-05923-36501-6, 6-05923-36502-3 and 6-05923-10563-6) and DermaFreeze365™ Neck & Chest (UPC Code 6-05923-36503-0) products. This recall was a result of certain limited lots testing positive for the Pseudomonas aeruginosa bacteria.

The organism, Pseudomonas aeruginosa may cause serious eye infections, urinary tract infections, respiratory system infections, dermatitis, soft tissue infections, bacteremia, bone and joint infections, gastrointestinal infections and a variety of systemic infections, particularly in patients with severe burns and in cancer and AIDS patients who are immunosuppressed. Pseudomonas aeruginosa infection is a serious problem in patients hospitalized with cancer, cystic fibrosis, and burns. Because the DermaFreeze365™ Instant Line Relaxing Formula may be applied in the area of the eye, there is a possibility that inadvertent introduction of the tainted product directly in the eye could result in serious eye infections and, in rare circumstances, possibly blindness.

Woodridge Labs is working with the third party manufacturer of the affected products to identify the source of the contamination in order to ensure that new lots of DermaFreeze365™ Instant Line Relaxing Formula and DermaFreeze365™ Neck & Chest products will be safe for future use.

Consumers that have the product should discontinue use of the product and destroy it immediately, or return it to their place of purchase for further processing. Consumers who have used the product and have concerns should consult a healthcare professional. Consumers with questions regarding the recall may contact Woodridge Labs, Inc. at 818-902-5537 or email to recall@woodridgelab.com.

WEEK ENDING MARCH 31

PRODUCT Ultra Brite Advanced Whitening All in One Clean Mint Toothpaste in a 6.0 oz tube, over-the-counter, Distributed by Colgate-Palmolive Company, New York, NY NDC # 065954-064-60; SKU 0156685, UPC 3500056685, CODE Lots 6293, 6294, 6295, 6296, 6297, 6301, 6302, 6303, 6304 and 6305. All lots expire between 10/08 and 01/09.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Colgate Palmolive Company, Jeffersonville, IN, 
Manufacturer: Colgate Palmolive Company, Mission Hills, Mexico. 
REASON Misbranded; The label ingredient statement is incorrect. The product contains the following ingredients which are not declared: sodium fluoride, PEG-12 and cocamidopropyl betaine and does not contain the following ingredients which are declared: sodium monophosphate, alumina and glycerin.
VOLUME OF PRODUCT IN COMMERCE 1,441,200 tubes
DISTRIBUTION Nationwide

PRODUCT Breckenridge Pharmacuetical Sulfatol Cleanser, Sodium Sulfacetamide 10%, Sulfur 5% in Urea vehicle, Rx Only, Net Wt. 355 mL tubes, 
CODE Lot Numbers: 50718E02/07; 50712E06/07; 50329E02/07; 60615E05/08
RECALLING FIRM/MANUFACTURER Sheffield Laboratories, Div. of Faria Limited LLC, New London, CT
REASON Product is subpotent
VOLUME OF PRODUCT IN COMMERCE71,848 tubes
DISTRIBUTION FL

PRODUCT Hydrocortisone Lotion, USP 2.5% (each mL contains 25mg of hydrocortisone in a vehicle consisting of carbomer 940, cetyl alcohol, cholesterol, isopropanol myristate, polysorbate 40, propylene glycol, propylene glycol monostearate, purified water, simethicone, sorbic acid, sorbitan palmitate, and trolamine), 2 fl oz., Rx only, NDC # 0603-7785-52, ANDA: 40-417, CODE Lot No. L025K06A, EXP 10/08
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals LLC, Huntsville, AL,
REASON Superpotent at 3 months for Hydrocortisone
VOLUME OF PRODUCT IN COMMERCE 3935 bottles
DISTRIBUTION Nationwide and PR

Withdrawal of Pergolide Products

Manufacturers of pergolide drug products, which are used to treat Parkinson’s disease, will voluntarily remove these drugs from the market because of the risk of serious damage to patients’ heart valves.

The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured by Par and Teva. Pergolide is in a class of medications called dopamine agonists and is used with levodopa and carbidopa to manage the symptoms (tremors and slowness of movement) of Parkinson’s disease.

In 2006, an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies in the United States. Patients taking pergolide should contact their doctors to discuss alternate treatments. Patients should not stop taking the medication, as stopping pergolide abruptly can be dangerous.

There are alternative therapies available for Parkinson’s disease, including three other dopamine agonists that have not been associated with valvular heart disease. The removal of pergolide products is not expected to adversely affect patient care because of the alternative therapies available.

Two recent New England Journal of Medicine studies confirm previous findings associating pergolide with increased chance of regurgitation (backflow of blood) of the mitral, tricuspid, and aortic valves of the heart. Valve regurgitation is a condition in which valves don’t close tightly, allowing blood to flow backward across the valve. Symptoms include shortness of breath, fatigue and heart palpitations.

In light of this additional post-market safety information, the companies that manufacture and sell pergolide will stop shipping pergolide for distribution and will withdraw the products from the market.

Permax was approved in 1988 for Eli Lilly and Company as an adjunctive therapy with levodopa in Parkinson’s disease. Valvular heart disease was first described in association with pergolide in 2002. In 2003, FDA asked Lilly to add valvulopathy (abnormality of cardiac valves) to the warnings section of Permax labeling, at which time a Dear Healthcare Practitioner letter was sent by Lilly. In 2006, the warning was upgraded to a black box warning, the FDA’s strongest form of warning, because of new data concerning risks of heart valve damage.

Public Health Advisory (PHA) is being issued detailing the removal of pergolide products from the market. The PHA, which is available at www.fda.gov/cder/drug/advisory/pergolide.htm includes information and recommended actions for physicians, pharmacists and patients.

The effect of the withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will allow time for health care providers and patients to discuss appropriate treatment options and time to change treatments.