JULY 2010

WEEK ENDING JULY 31 

Lundbeck Inc. Announces Recall of Two Lots of NeoProfen®
(ibuprofen lysine) Injection.  

Lundbeck Inc. is recalling  two lots of NeoProfen® (ibuprofen lysine) Injection that failed to meet a visible particulate quality requirement. 

The NeoProfen recall, NDC 67386–122-52, includes product lots 1734991 (expiration date: April, 2011) and 1922319 (expiration date: March, 2012).

For medical information questions about NeoProfen, please call 866-402-8520 or email luinc-druginfo@lundbeck.com. Product complaints related to NeoProfen should be reported to 800-455-1141 (phone), Monday to Friday from 8:00 a.m. to 5:00 p.m. central time, 847-282-1003 (fax), or luinc_safety@lundbeck.com.

Nutraloid Labs Inc. Conducts Recall of Two Dietary Supplements Found to Contain Undeclared Drug Ingredient 

Nutraloid Labs Inc. is recalling two dietary supplement products sold under the names: ejaculoid XXTREME and stimuloid II.

Nutraloid Labs Inc. has been informed  that lab analysis of ejaculoid XXTREME, Lot 79935, and stimuloid II, Lot 79936, found that the products contain sulfoaildenafil, similar in structure to Sildenafil. Sildenafil is an active ingredient of an drug for male Erectile Dysfunction (ED), making these products unapproved drugs. 

The recalled products listed below were distributed in black plastic bottles to distributors and via internet sales.

 Customers who have any of the above products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking these products. 

Consumers should return any unused product to the place of purchase or contact Nutraloid Labs Inc. directly at 1-772-291-7510, Monday – Friday, 10 am to 4 pm EDT

PRODUCT APOTEX CORP. Carbamazepine Tablets USP 200 mg 100 Tablets Rx Only, NDC 60505-0183-0. Batch JD2135. 
CODE Batch JD2135
RECALLING FIRM/MANUFACTURER
Recalling Firm: Apotex Corp., Weston, FL, 
Manufacturer: Apotex Inc., Toronto Ontario, Canada. 
REASON Product was manufactured with an API batch that was Out Of Specification (OOS) for an unknown impurity.
VOLUME OF PRODUCT IN COMMERCE
19,389 bottles
DISTRIBUTION
NH, NJ, KY, IL, TX, CA, CT, PA, SC, FL, OH, WI, AZ, LA, CO

WEEK ENDING JULY 24

PRODUCT Instant Hand Sanitizer (ethyl alcohol 62%) Topical Gel, Net contents one US Gallon (129 fl oz), OTC. 

Lot number: 080809 Exp. date 08/2010; 080909 Exp. date 08 /2010; 081009 Exp. date 08/2010; 081109 Exp. date 08/2010; 081309 Exp. date 08/2010.

Gasco Industrial, Gurabo, PR, 

REASON cGMP Deviations: The product was manufactured while several cGMP measures were not met.

8,000 gallons

DISTRIBUTION PR

PRODUCT Liothyronine Sodium Tablets, USP 5 mcg, RX only, Net contents 100 tablets, NDC0574-0220-01, UPC code (01) 00305740220016. 

CODE Lot # 9C548

Recalling Firm: Paddock Laboratories, Inc., Minneapolis, MN, 

Manufacturer: Metrics Inc., Greenville, NC. 

REASON The recall is being conducted due to a stability failure at the 12 month timepoint; the assay value of this lot was found to be sub-potent.

11,064 bottles

Nationwide including DC and PR

PRODUCT Motrin IB (Ibuprofen) Caplets USP, 200mg, Pain Reliever/Fever Reducer (NSAID), 24 Coated Caplets. 

Lot # SDA149 Exp Date 10/2010

McNeil Healthcare, LLC, Las Piedras, PR,

REASON Failed Dissolution Specification.

555,696

Nationwide, PR and Jamaica

PRODUCT IBUDONE (hydrocodone bitartrate and ibuprofen tablets), 5 mg/200 mg, 100 count bottles, Rx only. 

Lot # T036K09A, exp 11/11

Vintage Pharmaceuticals LLC, Huntsville, AL, 

REASON Subpotent (Multiple Ingredient Drug): Below specification for the assay at the room temperature 3-month stability time-point for Ibuprofen and Hydrocodone Bitartrate.

6,372 units

Nationwide

1) Honey Lemon Soothing Cough Drops (Menthol) 9.1 mg, Individually twist wrapped drops; Packaged under the following labels and packaging: a) Smith Brothers Honey Lemon Soothing Cough Drops; i) 30 drop bag, 12 bags per case, item F8023, UPC 0 72560 08023 5; ii) 50 drop bag, 12 bags per case, item F8106, UPC 0 72560 08106 5; b) CVS Honey Lemon Cough Drops, individually twist wrapped drops, 10 drops per bag, 36 bags per case; item F7243, UPC 0 50428 12750 6. 

2) Menthol Eucalyptus Soothing Cough Drops (Menthol) 6.5 mg, packaged under the following labels and packaging: a) Smith Brothers Menthol Eucalyptus Soothing Cough Drops, Individually twist wrapped drops in 40 drop bags, item F8038, UPC 0 72560 08038 9; b) Smith Brothers Menthol Eucalyptus Cough Drops, individually twist wrapped drops in 2 lb. plastic jar, 6 jars per case, item F2972. 

3) Therastat Cough Lozenges (Menthol) 7 mg, Cherry Flavor, Individually twist wrapped lozenges in a 30 lb. bulk carton; item F5127. Recall # D-692-2010;

4) Thoracol Cough Lozenges, Honey Lemon (Menthol) 8 mg, individually twist wrapped lozenges in a 30 lb. bulk pack; item F5125. 

1) Lot numbers: 0098, 0060;

2) Lot number: 0069;

3) Lot number: 0097;

4) Lot numbers: 0098

F & F Foods, Inc., Chicago, IL,

REASON Subpotent (Single Ingredient Drug): Cough drops are out of specification for menthol.

1,621 cases

Nationwide, India

PRODUCT UltraTag RBC, Kit for the Preparation of Technetium TC 99m-Labeled Red Blood Cells, Sterile, non-pyrogenic, For Intravenous use after drug preparation, Kits, Rx Only, NDC 0019-N068-B0. 

CODE Lot: 068-0003, Exp. 04/13/11

Recalling Firm: Mallinckrodt Inc., Hazelwood, MO,

Manufacturer: Mallinckrodt Inc., Maryland Heights, MO. 

REASON CGMP Deviations: The reaction vial was not packaged in some of the clamshell containers.

7,145 kits

Nationwide

PRODUCT Heparin Sodium, USP (API) #: NDC #: 046655 000009 and DMF #: 2712, powder, store at or below 30C. 

Lot 80405A Exp. 10/25/08

Pfizer Inc, Franklin, OH,

REASON Impurities/Degradation Products: Heparin Sodium, USP lot 80405A is outside the endotoxin specification of not more than 0.03 EU/U.

83.403 kg

DISTRIBUTION NY

J & H Besta Corp. Issues a Recall of Joyful Slim Herb Supplement Found to Contain an Undeclared Drug Ingredient 

J & H Besta Corp. of Hicksville, NY, is recalling Joyful Slim Herb Supplement because it was found to contain undeclared Desmethyl Sibutramine. Sibutramine is an approved drug used as an appetite suppressant for weight loss. 

Joyful Slim Herb Supplement is marketed as a Natural Herb for Weight Loss. Joyful Slim Herb Supplement is packaged in plastic bottles containing 30 capsules per bottle and bears UPC 8 97966 00200 7. The affected lot/code being recalled is 101408. The product was sold to distributors and retail stores nationwide and via internet sales. 

Consumers should not consume the Joyful Slim Herb Supplement and should return it immediately to the place of purchase for a full refund.

Consumers with questions should contact Jason Wang at 877-547-5468, Monday through Friday, 10:00 am to 5:30 pm, EDT. 

WEEK ENDING JULY 17

Good Health, Inc. Issues a  Recall of Product Marketed as Dietary Supplement 

Good Health, Inc. is recalling  dietary supplement Vialipro for sexual enhancement sold under the Lot Numbers listed below.

Vialipro Sold Under the Following Lot Numbers

Lot Number
80409	Capsules, 10 Count	All Dates
80661	Capsules, 10 Count	All Dates
81146	Capsules, 10 Count	All Dates
90132	Capsules, 10 Count	All Dates
90265	Capsules, 10 Count	All Dates
90587	Capsules, 10 Count	All Dates
90826	Capsules, 10 Count	All Dates
91065	Capsules, 10 Count	All Dates
00197	Capsules, 10 Count	All Dates
'00347	Capsules, 10 Count	All Dates

We urge consumers who have purchased Vialipro to discontinue its use and return it to Good Health, Inc.. Customers can call Good Health, Inc. at 1 (866) 607-0338 Monday through Friday from 9:00 am - 5:00 pm MST for instructions on the return and refund process. 

Distributors are advised to stop selling Vialipro and contact Good Health, Inc. at 1 (866) 607-0338 for further instructions. 

J & H Besta Corp. Issues a Recall of Slim- 30 Herb Supplement Found to Contain an Undeclared Drug Ingredient 

J & H Besta Corp. of Hicksville, NY, has been informed that Slim-30 Herb Supplement was found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine. 

Slim-30 Herb Supplement is marketed as a Natural Herb for Weight Loss. Slim-30 Herb Supplement is packaged in plastic bottles containing 30 capsules per bottle and bears UPC 8 31457 005009 2. The affected lot/code being recalled is 032009. The product was sold to distributors and retail stores nationwide and China and via internet sales.

Consumers should not consume the Slim-30 Herb Supplement and should return it immediately to the place of purchase for a full refund. 

Consumers with questions should contact Jason Wang at 516-735-1436, Monday through Friday, 10:00 am to 5:30 pm, EDT.

PRODUCT Ondansetron in 5% Dextrose Injection, 32 mg/50 mL (0.64 mg/mL), Single-Dose Premix Bag, Rx only, packaged in 6 x 50 mL Premix Bags per case, shipped in 48 (8 cases x 6 bags) x 50 mL Premix Bags per shipper carton. Made in India; NDC 25021-776-50, UPC 3 25021 77650 6.
CODE
Lot #: A090309, A090310, A090311 and A090312, Exp 05/31/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sagent Pharmaceuticals, Inc., Schaumburg, IL
REASON Non-Sterility: This product is being recalled because a white feathery substance found floating inside the IV bag was identified as mold.
VOLUME OF PRODUCT IN COMMERCE
36,852 bags
DISTRIBUTION
Nationwide and PR

PRODUCT Glumetza, metformin hydrochloride, Extended Release Tablets, 500 mg, physician samples and 100 count bottles. 
CODE
Physician Samples: Additional codes/Expiration dates added June 18, 2010: 09T4531A/September 2013, 09T6651A/September 2013, 09T6661A/September 2013, 09T6671A/September 2013, 09T11511A/September 2013, 10T0631A/March 2014, 10T1851A/March 2014, 10T1861A/March 2014, 10T2621A/March 2014 ------ Trade Lot numbers 09T4501A (Expiration date JUL 2013, Manufactured on July 16, 2009, Packaging date August 15, 2009), 09T4511A (Expiration date JUL 2013, Manufactured on July 17, 2009, Packaging date August 15, 2009), 09T4521A(Expiration date JUL 2013, Manufactured on July 18, 2009, Packaging date August 15, 2009) , 09T6681A (Expiration date SEP 2013, Manufactured on September 29, 2009, Packaging date October 9, 2009), 09T6691A 09T6681A (Expiration date SEP 2013, Manufactured on September 30, 2009, Packaging date October 10, 2009), 09T6701A (Expiration date SEP 2013, Manufactured on September 30, 2009, Packaging date October 10, 2009), 09T6711A (Expiration date OCT 2013, Manufactured on October 1, 2009, Packaging date October 10, 2009) , 09T7131A (Expiration date OCT 2013, Manufactured on October 1, 2009, Packaging date October 10, 2009), 09T9091A (Expiration date OCT 2013, Manufactured on October 1, 2009, Packaging date October 15, 2009) , 09T9101A (Expiration date OCT 2013, Manufactured on October 2, 2009, Packaging date October 15, 2009), 09T9111A (Expiration date OCT 2013, Manufactured on October 6, 2009, Packaging date October 15, 2009), 09T9121A (Expiration date OCT 2013, Manufactured on October 7 2009, Packaging date October 15, 2009), 09T9131A(Expiration date OCT 2013, Manufactured on October 7, 2009, Packaging date October 16, 2009). Additional lot codes /Expiration dates added on June 11, 2010: 09T2151A/ March 2013, 09T2161A/ March 2013, 09T2141A/March 2013, 09T2701A/March 2013, 09T731A/March 2013, 09T2741A/March 2013, 09T2751A/March 2013, 09T2771A/March 2013, 09T2761A/March 2013, 09T2781A/March 2013, 09T3631A/May 2013, 09T3641A/May 2013, 09T3651A/May 2013, 09T3661A/May 2013, 09T4431A/June 2013, 09T4421A/June 2013, 09T4441A/July 2013, 09T4451A/July 2013, 09T4461A/July 2013, 09T4471A/July 2013, 09T4481A/July 2013, 09T4491A/July 2013, 09T9141A/October 2013, 09T9151A/October 2013, 09T9161A/October 2013, 09T9171A/October 2013, 09T9181A/October 2013, 09T9191A/October 2013, 09T9201A/October 2013, 09T9211A/October 2013, 09T9221A/October 2013, 09T9231A/October 2013, 09T9241A/October 2013, 2013, 09T9251A/October 2013, 09T9691A/October 2013, 09T9701A/October 2013, 09T11521A/October 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Depomed Inc., Menlo Park, CA,
Manufacturer: Patheon Puerto Rico, Inc., Caguas, PR. REASON
Chemical contamination; TBA (2,4,6 tribomoanisole).
VOLUME OF PRODUCT IN COMMERCE
50,679 bottles/100 tablets per bottle
DISTRIBUTION
Nationwide

Bristol-Myers Squibb Initiates a Recall of Coumadin® 1 mg Tablet Blister Packs

Bristol-Myers Squibb is recalling 3 lots of physician sample blister packs of Coumadin® 1 mg tablets and 5 lots, of Coumadin 1 mg tablet hospital unit dose (HUD) blister packs. The following lot numbers are included in this recall: Physician Sample Blister Packs: Lot# 9A48931A, 9A48931B, 9A48931C, expiration January 2012; HUD Blister Pack: Lot# 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012.  Some of the tablets, over time, may not meet specification for isopropanol. Isopropanol is used to maintain the active ingredient, Coumadin, in the crystalline state, and could affect the therapeutic levels of the active ingredient.

The recall only involves Coumadin 1 mg tablet blister-packs distributed in the U.S. 

Healthcare professionals and customers may call the following for assistance if they have further questions about the recall: 

 WEEK ENDING JULY 10

PRODUCT 
1) D-DROL capsules, D-Drol Complex 52.5 mg, (2a,17a-dimethyl-5a-androstane-3-one-17b-ol, Estra-4,9-diene-3,17-dione,17a-Methyl-etioallocholan-2-ene-17b-ol), Bergamottin (DHB) 25 mg, Liver Support Complex 300 mg, 60-count bottles, UPC 871938009560. 

2) DIENE DRONE capsules, (Estra-4, 9-diene-3, 17-dione) 50 mg, Enhancement Complex: Milk Thistle 100 mg, Piperine 5 mg, Luteolin 4 mg, 60-count bottle, UPC 893461001194. 

3) Liquid drone UTT anabolic suspension, (Estra-4, 9-diene-3, 17-dione) 12.5 mg, 60 mL bottle, UPC 893461001279. 

4) HYPERDROL X2 capsules, (6-BROMODIONE) 50 mg, X2 Support Matrix 260 mg, 120-count bottle, UPC 791851111266. 

5) MASTAVOL capsules, (2a-17a-DIMETHYL-5a-ANDROST 3-ONE-17b-OL) 10 mg, 90-count bottles, UPC 649241879732. 

6) REVAMP capsules, (Estra 4, 9-diene-3,17-dione) 30 mg, (2a, 3a-epithio-17a-methyl-5a-androstane-17b-ol) 10 mg, 90-count bottles, UPC 649241873501. 

7) ULTRA MASS STACK capsules, (19-NORANDROSTA-4,9 DIENE-3,17 DIONE) 40 mg, (17A-METHYL-ETIOALLOCHOLAN-2-ene-17b-ol) 10 mg, 90-count bottles, UPC 649241870913. 

8) ULTRA RIPPED STACK capsules, (19-norandrosta-4,9 diene-3,17 dione) 30 mg, (2a-17a-dimethyl-5a-androst-3-one-17b-ol) 10 mg, 90-count bottles, UPC 649241870906. 

9) Finadex capsules, Finadex Proprietary Blend 695 mg, 90-count bottle. 

10) STRAIGHT DROL capsules, (17a-Dimethyl-5a-Androst-3-One17b-Ol) 10 mg, 60-count bottles. 

11) STRAIGHT PHLEXED capsules, (17a-Methyl-etioallocholan-2-ene-17b-ol) 10 mg, 60-count bottles. 

12) TESTRA FLEX capsules, (Estra 4, 9-diene-3,17-dione) 25 mg, 90-count metal cans, UPC 689076771733. 

13) METHYLDROSTANOLONE tablets, (2a-17a-dimethyl-5a-androst 3-one) 10 mg, 3 x 10-count blister packs in a box, UPC 094922593658. 

14) EPI-TREN capsules, (Estra-4,9-diene-3, 17-dione) 30 mg, (2a, 3a,-epithio-17a-methyletioallocholanol) 10 mg, 90-count bottles. 

15) Magna Drol capsules, (3,2-c]pyrazole-5alpha-etioallocholane-17beta tetrahydropyranol) 30 mg, (17a-Methyl-etioallocholan-2ene 17b-ol) 10 mg, 90-count bottles. 

16) Epivol capsules, (Estra 4, 9-diene-3,17-dione) 30 mg, (2a,3a-epithio-17a-methyletioallocholanol) 10 mg, 90-count bottles. 

17) Pheravol-V capsules, (17a-Methyl-etioallocholan-2-ene-17b-ol) 10 mg, 90-count bottles. 

18) M-DROL capsules, (2a 17a di methyl etiocholan 3-one. 17b-ol) 10 mg, 90-count bottles, UPC 891192002015. 

19) P-PLEX capsules, (17a-Methyl-etioallocholan-2-ene-17b-ol) 10 mg, 90-count bottles, UPC 891192002046. 

20) X-TREN capsules, (19-Noradrosta-4,9 diene-3,17 dione) 30 mg, 90-count bottles, UPC 891192002091. 

21) EPIO-PLEX capsules, (2,3A-EPITHIO-17A-METHYLETIOALLOCHOLAN-17B-OL) 10 mg, (17A-METHYL-ETIOALLOCHOLAN-2-ENE-17B-OL) 10 mg, Milk Thistle 70 mg, AAKG 350 mg, Uva Ursi 125 mg, 90-count bottles. 

22) FINABOLIC 50 capsules, (19 NORANDROSTA 4,9 DIENE 3, 17 DIONE) 50 mg, 90-count bottles. 

23) REVENGE capsules, (2A, 17A DIMETHYLETIOCHOLAN 3-ONE, 17B-OL) 15 mg, (2-ENE (17A-METHYL-ETIOALLOCHOLAN-2-ENE-17B-OL)) 10 mg, (ESTRA-4, 9-DIENE-3, 17DIONE) 40 mg, 60-count bottles. 

24) MethAnstane capsules, (2-alpha-17 alpha-dimethyl-5 alpha-androst-3-one), Proprietary Blend: 62.5 mg (5a-Etioallocholan[2,3-C]furazan-17b-Tetrahydropyranol Ether), (2-alpha-17 alpha-dimethyl-5alpha-androst-3-one), 60-count bottles, UPC 895524000793. 

25) Susto-Test Depot capsules, (17a-Methyl-Androst-1 4-Diene-3-17b-Diol) 100 mg, (Estra-4 9-Diene-3 17-Dione) 75 mg, (6,7 Dihydroxybergamottin) (DHB) 155 mg, (13-Ethyl-emethyl-Gona-Diene-17) 75 mg, (6,17 Dito-Etiocholene-4-Ol) 75 mg, Magnesium 100 mg, Zinc 10 mg, Bioperine 10 mg, 90-count bottle. 

26) ON CYCLE II HARDCORE capsules, 80% Milk Thistle Extract 100 mg, (4-Chloro-17a-methyl-androst-1,4-diene-3,17b-diol) 25 mg, Lecithin (LPC) 20 mg, (Estra 4,9 Diene 3,17 Dione) 10 mg, (2a,17a-dimethyl-etiocholan 3-one, 17b-Ol) 5 mg, Bioperine 5 mg, 30-count bottle, UPC 876436000637. 

27) SUS500 softgels, Active Ingredients: Estra-4 9-Diene-3 17-Dione, 13-Ethyl-3-Methoxy-Gona2, 5(10)-Diene-17-One, 3, 17 Ketoetiochol-Triene, Silymarin Extract, TPGS (Advanced Delivery System), In A Base of Safflower Oil, Geletin, 60-count bottles. 

28) TREN-250 softgels, Active Ingredients: Estra-4, 9-Diene, TPGS 78 mg Safe Methyl Process, Vitamin E 1mg. In A Base Of 267 mg Safflower Oil, Geletin, 25 mg, 60-count bottles. 

29) T-ROID capsules, (19-Norandrosta 4,9 Diene 3,17 Dione) 30 mg, 90-count bottles, Hardcore Forumlations. 

30) 1,4 AD BOLD 200 capsules, (1,4 Androstadiene-3, 17-dione) 200 mg, 60-count bottles, UPC 854503001145. 

31) 17a PheraFLEX capsules, (17a-Methyl-Etioallocholan-2-ene-17b-OL) 15 mg, 90-count bottles, UPC 854503001176. 

32) DYMETHAZINE capsules, 15 mg, 60-count box, UPC 854503001206. 

33) 2a,17a Methadrol capsules, (2a 17a di methyl etiocholan 3-one, 17b-ol) 10 mg, 90-count bottles, UPC 854503001152. 

34) BROMODROL tablets, Bromodrol Growth Complex 531 mg (Green Tea, Hoelene, Bergamottin, Bupleurum, 6 Bromo 3, 17 dioxoetioallocholane, Nettle Root, Chrysin, Saw Palmetto, Schizandra Berry, Wild Yam, Safed Musli), 60-count foil packed tablets in a box, UPC 675941002507.

35) GROW TABS capsules, 582 mg, Proprietary Testopen Blend (Kudzu root, Green Tea, Zinc aspartate, Pygeum africanum extract, Stinging nettle leaf extract, 17 alpha methyl 17 beta hydroxyl 5 alpha androst 2 ene, 4 Androstene 4 chloro 17 alpha methyl 3 beta 17 beta diol, Urtica Dioica, Tongkat Ali (malaysian Eurycoma Longifolia Jack), Dodder Seed) 250 mg, Bergamottin 50 mg, Bupleurum 50 mg, Hoelen 50 mg, 60-count foil packed capsules in a box, UPC 675941002521. 

36) MASS TABS capsules, Proprietary Mass Tabs Blend 87,000 mcg (Kudzo Extract 40%, Trifolium Pratense Extract 8%, Fenugreek Seed Powder, Tribulus Terrestris Extract 40%, MethylSten, Avena Sativa Extract 10:1, Pygeum Africanum Bark Extract 4:1, Milk Thistle, Maca Powder Extract .6%, Epimedium Leaf, Bacopa Monniera Extract 4:1, Rhodiola Rosea 3%, Nettle Leaf Powder), 30-count bottles, UPC 675941001494. 

37) OXODROL PRO tablets, Supplement Facts: Hoenelen 100 mg, Bupleurium 100 mg, Bergamottin 100 mg, Green Tea 100 mg, Proprietary Blend 150 mg (Nettle Leaf Powder, Maca Powder Extract, Avena Sativa Extract, Fenugreek Seed Powder, Tribulus Terrestris Extract), (2alpha, 3alpha-epithio-17alpha-methyletioallocholanol) 10 mg, 60-count foil packed tablets in a box, IDS. 

38) RIPPED TABS TR capsules, Anabolic AmplifierTM Proprietary Blend (Hoenelen, Buplurium, Bergamottin) 300 mg; Energy XT Proprietary Blend (Green Tea, Caffeine USP, Mateine) 500 mg; Anabolic Cutter Blend (1,3,7-trimethyl-1H-purine-2,6 (3H,7H) dione, 19 Norandrosta 4, 9 diene 3, 17 dione) 257 mg; 60-count bottle, UPC 675941001623. 

39) Massdrol capsules, (2a, 17a-Dimethyl-5a-Androst-3-One, 17B-0l) 10 mg, 60-count bottles. 

40) Phera-Mass capsules, (17a-Methyl-Eticoallocholan-2-Ene-17b-Ol) 10 mg, 60-count bottles, KiloSports. 

41) Trenadrol capsules, (17b-Methoxy-Trienbolonein) 30 mg, 60-count bottles, KiloSports.

42) MONSTER CAPS capsules, Milk Thistle 150 mg, Proprietary Blend (4-chloro-17a-methyl-etioallocholan-1, 4-diene-3, 17-diol 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one 2a,17a di-methyl etiocholan 3-one, 17b-ol 6,7 Dihydroxybergamottin) 60 mg, 60-count bottles, UPC 689076956505. 

43) Spawn capsules, (Estra-4 9-Diene-3 17 Dione ) 30 mg, (2a, 3a-Epithio-17a-Methyletioallocholanol) 8 mg, 90-count bottles, Myogenix Products.

44) D-STiANOZOL tablets, (17a-Methyl-etioallocholan-2-ene-17b-ol) 10mg, 60-count bottles,  UPC 8272386000284. 

45) H-DROL tablets, (polydehydrogenated, polydehydroxylated halomethetioallocholane) 25 mg, 60-count bottle, UPC 8272386000369. 

46) MD1T capsules, L-Arginine Alpha-Ketoglutarate (AAKG) 1000 mg, Uva Ursi (Leaf) (Arctostaphylos Uva-Ursi) 400 mg, Milk Thistle (80% Silymarin) 200 mg, (19-Norandrosta 4, 9 Diene 3, 17 Dione) 50 mg, (17a-Methyl-Etioallocholan-2-Ene- 17b-01) 20 mg, 90-count bottle, Nutracoastal. 

47) Nutracoastal S-Drol tablets, (2a, 17a-Dimethyl-5a-Androst-3-One, 17b-OI) 10 mg, 60-count bottles, Nutrcoastal. 

48) TRENA tablets, (19-norandrosta-4,9-diene-3,17-dione) 25 mg, 90-count bottles, UPC 8272386000383. 

49) 2a, 17a METHASTADROL capsules, (2a, 17a di methyl etiocholan 3-one, 17b-ol) 10 mg, 90-count bottles, UPC 089935100207. 

50) TRI-METHYL X capsules, vitamin C 60 mg, Vitamin B-12 24 mcg, (2a, 17a di-methyl etiocholan 3-one, 17b-ol) 10mg, (17a-Methyl-etioallocholan -2-ene-17b-ol) 10 mg, (4 chloro17amethylandrost-1,4diene-3-17b-diol) 20 mg, 60-count bottles, UPC 089935100214. 

51) e-pol capsules, (2a,17a-dimethyl-5a-androstane-3-one-17b-ol) 15 mg, (Estra-4,9-diene-3,17-dione) 30 mg, InSLINsified Proprietary Insulin Mimetic 250.5 mg, 60-count bottles, UPC 855279025144. 

52) Nasty mass capsules, (13-ethyl-3-methoxy-gona-2,5(10) dien-17-one) 25 mg, (17a-Methyl-etioallocholan-2-ene-17b-ol) 10 mg, InSLINsified Proprietary Insulin Mimetic 250.5 mg, 60-count bottles, UPC 793214256904. 

53) RAGE RV2 capsules, (1,4-androstadiene-3,17-dione) 150 mg, (Estra-4,9-diene-3, 17-dione) 30 mg, 90-count bottles, UPC 718122731350. 

54) RAGE RV3 capsules, (17a-methyl-1,4-androstadiene-3,17-diol) 26 mg, (Estra-4,9-diene-3, 17-dione) 26 mg, (13-ethyl-3-methoxy-gona-2,5(10) dien-17-one) 20 mg, (1,4,6-androstatriene-3,17-dione) 20 mg, 60-count bottles, UPC 718122747122. 

55) RAGE RV4 capsules, (17a-methyl-1,4-androstadiene-3,17-diol) 25 mg, (Estra-4,9-diene-3, 17-dione) 20 mg, (2a, 3a-epithio-17a-methyl-5a-androstan-17b-ol) 8 mg, 60-count bottle, UPC 718122747320. 

56) RAGE RV5 capsules, (4 chloro17amethylandrost-1,4diene 17b-ol) 25 mg, (2a,17a di methyl etiocholan 3-one, 17b-ol) 10 mg, (17a-Methyl-etioallocholan-2-ene-17b-ol) 10 mg, 60-count bottles, UPC 718122747221. 

57) FINAFLEX 550-XD capsules, (2a, 17a-Di-methyl-etiocholan-3-one, 17B-ol) 10 mg, (Estra-4,9-diene-3,17-dione) 25 mg, (3, 17 ketoetiochol-triene) 10 mg, Milk Thistle (80% Silymarin) 120 mg, NAC (N-Acetyl Cysteine) 250 mg, Vitamin C (ascorbic acid) 50 mg, 60-count bottles, rd labs, UPC 689466048865. 

58) FINAFLEX RIPPED capsules, (1,4Androstadiene-3,17-dione) 100 mg, (Estra-4,9-diene-3,17-dione) 30 mg, Caffeine Anhydrous 100 mg, Dandelion Root 200 mg, Green Tea Extract (60% EGCG) 200 mg, Vitamin B6 100 mg, 60-count bottles, UPC 689466130577.

59) FORGED EXTREME MASS capsules, Proprietary Blend (17a-methyl-etioallocholan-2-ene-17b-o 4 chloro 17a methyl androst-1,4 diene-3-17b-diol Estra-4,9-diene-3) 65 mg, 60-count bottles, transform Supplements, UPC 788903093748. 

60) FORGED LEAN MASS capsules, Proprietary Blend (2a,17a-dimethyl-17b-hydroxy-5a-androstane-3-one 17a-methyl-etioallocholan-2-ene-17b-ol 3,17- keto-etiochol-triene) 55 mg, 60-count metal cans, transform Supplements, UPC 788903057924. 

61) RIPPED TABS TR tablets, Anabolic Amplifier Proprietary Blend (Hoenelen, Buplurium, Bergamottin) 300 mg, Energy XT Proprietary Blend (Green Tea, Caffeine USP, Mateine) 425 mg, Anabolic Cutter Blend (1,3,7-trimethyl-1H-purine-2,5 (3H,7H) dione, 19 Norandrosta 4, 9 diene 3, 17 dione, Juniper Berry, Cornsilk Stylus, Bulgarian Tribulus Terrestris (Standardized at a 25% saponin content), Fenugreek seed, Theine, Acetyl-L Carnatine, Zinc (as zinc aspartate), Stinging nettle leaf, Maca Root, Eurycoma Longifolia, Couchgrass Rhizome) 234 mg, 60-count foil packed blisters per box, UPC 675941001623. 

62) IForce Dymethazine/Reversitol Combo Pack. 

CODE All lots and codes.
RECALLING FIRM/MANUFACTURER Bodybuilding.Com, Meridian, ID, 
REASON Marketed Without an Approved NDA/ANDA: 62 products marketed as dietary supplements have been found to contain steroid or steroid-like substances, making them unapproved new drugs.
VOLUME OF PRODUCT IN COMMERCE 48,890 bottles   
DISTRIBUTION Nationwide and Internationally

PRODUCT 
Metronidazole Injection, USP, 500 mg/100 mL (5 mg/mL), Single Dose Premix Bag, Rx only, 24 bags per case; NDC 25021-131-82, UPC 3 25021 13182 4. 
CODE
Lot #: A090742, A090743, A090744, A090745, A090746, A090769, A090770, A090771, A090772, A090773, A090774, Exp 09/11; A090775, A090776, Exp 10/11; A090968, A091014, Exp 11/11; A000013, A000016 and A000019, Exp 12/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sagent Pharmaceuticals, Inc., Schaumburg, IL, 
Manufacturer:  Claris LifeSciences Limited, Ahmadabad, India. 
REASON Non-Sterility: This product is being recalled because of two complaints of a white feathery substance floating inside the IV bag which was identified as Mucor spp. fungus.
VOLUME OF PRODUCT IN COMMERCE 142,176 bags
DISTRIBUTION Nationwide

PRODUCT Isosorbide Mononitrate Extended-Release Tablets, 30 mg, Rx only, 100 and 1000 count bottles.
CODE Lot 0913001 (100) and 0913002 (1000)
RECALLING FIRM/MANUFACTURER Schwarz Pharma Manufacturing, Inc., Seymour, IN, 
REASON Tablet Thickness; presence of thicker, overweight tablets due to presence of start-up waste in acceptable product.
VOLUME OF PRODUCT IN COMMERCE 28543 bottles (100 count tablets); and 1082 bottles (1000 count tablets)
DISTRIBUTION Nationwide and PR

PRODUCT ISMO Tablets (Isosorbide mononitrate) 20 mg, Rx only, 100 count bottles, Scored,
NDC: 67857-702-01. 
CODE Lot number 62519A, Exp 10/2010; Lot 66948A, Exp 6/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Promius Pharma, LLC, Bridgewater, NJ, 
Manufacturer: West-ward Pharmaceutical Corp., Eatontown, NJ. 
REASON Failed Dissolution Specification; 44 month time point.
VOLUME OF PRODUCT IN COMMERCE 19,476 units
DISTRIBUTION Nationwide

McNeil Consumer Healthcare Announces Recall of Certain Over-The-Counter (OTC) Products 

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling 21 lots of over-the-counter medicines. The lots involved, listed below, are sold in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica because of consumer complaints of a musty or moldy odor, which has been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA).

Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions, and information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com¹ or call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Consumers who have medical concerns or questions should contact their healthcare provider.

he product lot numbers for the recalled products can be found on the side of the bottle label. 

FULL RECALLED PRODUCT LIST:

WEEK ENDING JULY 3

PRODUCT 
1) Zicam Cold Remedy Nasal Gel (Zincum Gluconium 2X) 0.50 fl oz bottle, packaged in single and Twin Pack boxes; UPC: 7322160121 and UPC: 7322160201208.

2) Zicam Cold Remedy Gel Swabs, (Zincum Gluconium 2X) in boxes of 20 and 34 medicated swabs; UPC: 732216201017 and UPC: 732216300505.
CODE All lots
RECALLING FIRM/MANUFACTURER
Matrixx Initiatives Inc., Scottsdale, AZ,
REASON Reports of Adverse Events: use of product has been associated with anosmia (loss of smell) which is a long-term or permanent condition.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

PRODUCT STUD Capsule For Men, Herbal Supplement, packaged in blister packs containing 1 capsule, UPC 7 83259 00051 8 Supplement Facts Serving Size: 1 Capsule; Servings Per Container: 1. Rhodiola Rhizome Extract 65 mg, Lycium Fruit Extract 35 mg, Chinese Yam Rhizome Extract 40 mg, Cnidium Fruit Extract 20 mg, Poria Selerotium Extract 25 mg, Tienchi Ginseng Extract 5 mg, Cistanche 45 mg. Other Ingredients: Cassia Extract, Asian Ginseng Extract, Rice Flour and Gelatin. Made in The USA.
CODE
Lot # 060607-01 060108-01, Exp. 6/2013
RECALLING FIRM/MANUFACTURER
Kanec USA, Inc., Davie, FL,
REASON Marketed Without an NDA/ANDA: product contains sildenafil, the active ingredient in an FDA approved drug used in the treatment of erectile dysfunction, making the product an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
150,000 capsules
DISTRIBUTION
Nationwide

PRODUCT MasXtreme Herbal Supplement for Men, Maximum Sexual Enhancement, Herbal Supplement for Men, 1 capsule per blister carton, 750 mg Proprietary Blend, UPC 0 94922 30080 5; Supplement Facts Serving Size: 1 Capsule Servings Per Container: 1 Amount per Capsule, Proprietary Blend: Chuchuhuasi (Bark), Maca (Root), Huanarpo Macho (Bark) (Jatropha macrantha), Catuaba (Bark), Evodia (Fruit) & Long Jack (Root) (Eurycoma longifolia) 750 mg. CODE Lot # 911035
RECALLING FIRM/MANUFACTURER
Recalling Firm: Natural Wellness, LLC, Deerfield Beach, FL,
Manufacturer: Florida Supplement Corp., Hollywood, FL.
REASON Marketed Without an Approved NDA/ANDA: Product contains undeclared amounts of Aildenafil, an analog of Sildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED). Product also contains the drug Phentolamine, which is used to expand blood vessels to increase blood flow.
VOLUME OF PRODUCT IN COMMERCE
202,176 capsules
DISTRIBUTION
Nationwide, Bahamas, Dominican Republic, and Barbados

PRODUCT Spectrum Kanamycin Sulfate, USP, (Kanamycin Monosulfate), Catalog #K1390, Sizes: 25g, 100g & 6 x 100g bottles. CODE
Lots YI0763 (Mfr. Lot 90803) & YK0432 (Mfr. Lot 90803)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Spectrum Chemicals and Laboratory Products, Gardena, CA
Manufacturer: North China Pharm., Shijiazhuang, China. REASON Presence of foreign substance; trimethoprin detected.
VOLUME OF PRODUCT IN COMMERCE
10,000g
DISTRIBUTION
Nationwide and New Zealand

PRODUCT 
1) PediaCare Children's Multi-Symptom Cold, Grape Flavor Liquid, 4 fl oz (118 mL), UPC 3 0045-0556-05 9, NDC 50580-556-04, OTC.

2) PediaCare Children's Long-Acting Cough, Grape Flavor Liquid, 4 fl oz (118 mL), UPC 3 0045-0465-04 7, NDC 50580-465-04, OTC.

3) PediaCare Children's Decongestant, Raspberry Flavor Liquid, 4 fl oz (118 mL), UPC 3 0045-0554-04 8, NDC 50580-554-04, OTC.

4) PediaCare Children's Allergy & Cold, Grape Flavor Liquid, 4 fl oz (118 mL), UPC 3 0045-0552-04 4, NDC 50580-552-04, OTC.
CODE All lots within expiry
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blacksmith Brands, Inc., Tarrytown, NY,
Manufacturer: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA.
REASON GMP deficiencies at manufacturing site.
VOLUME OF PRODUCT IN COMMERCE
2,328,984 units (total for 4 products)
DISTRIBUTION
Nationwide

PRODUCT Sertraline Hydrochloride Tablets, 100 mg, 1000 count bottles, Rx only, NDC 16714-613-06. CODE
Lot #: SR1009068-A, Exp 7/2011
RECALLING FIRM/MANUFACTURER
Aurobindo Pharma Limited, Andhra Pradesh, India
REASON Adulterated Presence of Foreign Tablets: One foreign tablet of Zolpidem Tartrate Tablets, 10 mg, was found in a bottle of 100 count Sertraline HCL Tablets, 100 mg.
VOLUME OF PRODUCT IN COMMERCE
948 bottles
DISTRIBUTION
Nationwide

PRODUCT Zolpidem Tartrate Tablets, 10 mg, CIV, 500 count bottle, Rx only, NDC 16714-622-02.
CODE
Lot #s: ZT1009034-A, Exp 7/2011; ZT1009036-A, Exp 7/2011
RECALLING FIRM/MANUFACTURER
Aurobindo Pharma Limited, Andhra Pradesh, India
REASON
Tablet Thickness: One oversize tablet was found in two lots of Zolpidem Tartrate Tablets, 10 mg, 500 count.
VOLUME OF PRODUCT IN COMMERCE
6,755 bottles
DISTRIBUTION
Nationwide

PRODUCT 
LITTLE TUMMYS Stimulant Laxative Drops (Sennosides 8.8mg/mL), 1 fl oz (30 mL) dropper bottle, OTC. UPC Code: 7 56184 12071 2; Product Code: 10756184123222. There are 24 packages in each case. CODE
Lots: 08288 (exp. 07/28/10), 08518 (exp. 12/18/10), 09415 (exp. 10/16/11), 09478 (exp. 12/03/11)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtech Products, Inc., Irvington, NY,
Manufacturer: Altaire Pharmaceuticals, Inc., Aquebogue, NY.
REASON Defective Container: seal breach on tamper evident foil seal.
VOLUME OF PRODUCT IN COMMERCE
193,992 bottles (8083 cases of 24 each)
DISTRIBUTION
Nationwide