APRIL 2004

WEEK ENDING APRIL 3

Aloe Commodities International, Inc., Recalls Solutions IE Ageless Formula II Due to Excess Vitamin D

Aloe Commodities International, Inc., Carrollton, Texas, is recalling 1600 bottles of Solutions IE Ageless Formula II, Lot numbers P2207 and P2221 because they contain a significantly higher-than-labeled level of vitamin D3. (Approximately 188,640 International Units (IU) are present in each serving size of 6 capsules instead of the intended level of 400 IU). The product is distributed by Solutions International, Inc., Orem, UT.

The 750 mg dietary supplement was packed 180 capsules per bottle and coded lot number P2207 or P2221. The lot coding can be found on the bottom of the bottle.

The product was distributed by independent distributors nationwide. Consumers who have purchased Solutions IE Ageless Formula II are urged to return it to either Aloe Commodities International, Inc., 2161 Hutton Drive, Carrollton, TX. 75006 or Solutions International, 1272 South 1830 West, Orem, Utah 84058.

Consumers with questions can contact either Mark McKnight, President, Aloe Commodities at 972-241-4251 or Brian Larson, President, Solutions International at 801-785-4002.

PRODUCT Diltia XT Capsules (diltiazem HCI extended-release capsules, USP) Once-A-Day Dosage, 240 mg, 100 count bottles, Rx Only.
CODE Lot Number/Expiration Date: 550C039 (11/04).
RECALLING FIRM/MANUFACTURER Andrx Pharmaceuticals, Inc., Fort Lauderdale, FL.
REASON Mislabeling: The recalled product lot was labeled with the incorrect expiration date of November 2004 rather than actual expiration of November 2003.
VOLUME OF PRODUCT IN COMMERCE 6,552.
DISTRIBUTION Nationwide.

PRODUCT Morphine Sulfate in 5% Dextrose Injection, Each mL contains morphine sulfate pentahydrate 1mg and dextrose hydrous 50mg, 1 mg/mL (250 ml total) Large Volume Glass Container, Rx only.
CODE Lot 04-736-DM.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, North Chicago, IL.
REASON Sub-potent; product labeled as containing 1mg/mL of Morphine Sulfate actually contains 0.2mg/mL of Morphine Sulfate.
VOLUME OF PRODUCT IN COMMERCE 10,536 bottles.
DISTRIBUTION Nationwide.

PRODUCT Levothroid Tablets (levothyroxine sodium tablets, USP) 50 mcg., 100-ct. bottles, Rx Only,.
CODE Lot #30265, Exp. April 30, 2004.
RECALLING FIRM/MANUFACTURER Forest Pharmaceuticals, Inc., Earth City, MO.
REASON Subpotent.
VOLUME OF PRODUCT IN COMMERCE 14,207/100-ct. bottles.
DISTRIBUTION Nationwide.

PRODUCT
a) Bromhist-DM Drops, (Brompheniramine Maleate 1 mg, Pseudoephedrine Hydrochloride 15 mg, and
Dextromethorphan Hydrobromide 4 mg), Rx Only.
b) Bromhist Pediatric Drops, (Brompheniramine Maleate 1 mg, Pseudoephedrine Hydrochloride 15 mg. Rx Only.
CODE
a) and b) Lot number/Expiration date: P03106 (1/2006).
RECALLING FIRM/MANUFACTURER Great Southern Laboratories, Houston, TX.
REASON Mislabeling: Bromhist-DM drops packaged in Bromhist Pediatric Drops carton. Carton is not labeled to contain Dextromethorphan Hydrobrimide 4mg/mL.
VOLUME OF PRODUCT IN COMMERCE 1,221 units.
DISTRIBUTION Nationwide.

PRODUCT ORPHENGESIC FORTE TABLETS (Orphenadrine Citrate, Aspirin, and Caffeine Tablets) 50 mg/770 mg/60 mg, 100 and 500 tablet bottles, Rx only, NDC 49884-473-01 - 100 Tablets and NDC 49884-473-05 - 500 Tablets.
CODE Lots 037407 and 037408, Expiration Date 3/2005.
RECALLING FIRM/MANUFACTURER Par Pharmaceutical, Inc., Spring Valley, NY.
REASON Subpotent; caffeine (9-month stabilty test).
VOLUME OF PRODUCT IN COMMERCE 7,648 bottles.
DISTRIBUTION Nationwide.

PRODUCT PREMARIN (conjugated estrogens tablets, USP), 0.625 mg, 1000 count bottles, Rx only.
CODE Lot Number/Expiration Date: A57921 (October 2005).
RECALLING FIRM/MANUFACTURER Richmond Division of Wyeth, Richmond, VA.
REASON Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE 48 bottles.
DISTRIBUTION Nationwide.

WEEK ENDING APRIL 10

PRODUCT VANTIN Tablets (cefpodoxime proxetil tablets), 200 mg, 20 tablet bottle, Rx only. Made in Belgium. CODE K08210301; Exp. 04/2008.
RECALLING FIRM/MANUFACTURER Graham Development Inc., Oneonta, NY.
REASON Mislabled; bottles labeled as Vantin 200 mg may actually contain Lanoxin 0.25 mg.
VOLUME OF PRODUCT IN COMMERCE 500 bottles.
DISTRIBUTION Nationwide.

PRODUCT FOAM CARE Mild, Medicated Handwash 0.5% pCMX, For External Use Only, 500 ml (16.9 fl. Oz). CODE Lot Numbers 200951, 201440, 202839, 203115, 210036, 211817.
RECALLING FIRM/MANUFACTURER Ballard Medical Products, Draper, UT.
REASON Microbial Contamination: Medicated handwash may be contaminated with Pseudomonas spinosa.
VOLUME OF PRODUCT IN COMMERCE 5,160 bottles.
DISTRIBUTION Nationwide.

PRODUCT Halls Sugarfree Citrus Blend Mentho-Lyptus Cough Drops, (Menthol 5mg), Vapor Action Formula, 25 Drops.
CODE Lot Number: 03114E.
RECALLING FIRM/MANUFACTURER Cadbury Adams USA Llc, Parsippany, NJ.
REASON Mislabeling: Presence of undeclared yellow #5 color additive.
VOLUME OF PRODUCT IN COMMERCE 960 cases.
DISTRIBUTION Nationwide.

PRODUCT Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) 0.5% with Epinephrine 1:200,000 (as bitartrate), Sterile Pak, Contains Five Presterilized 30 mL Single Dose Vials, Rx only.
CODE Lot Number: 310080 Exp. Date: October 2005.
RECALLING FIRM/MANUFACTURER AstraZeneca LP, Wilmington, DE.
REASON Lack of assurance of sterility - small hole or crack present in Sterile-Pak compromising the sterility of the vial exterior (not the drug).
VOLUME OF PRODUCT IN COMMERCE 6,650 sterile-paks.
DISTRIBUTION Nationwide.

PRODUCT Microgestin Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 28-Day Regimen, Each white tablet (21) contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. Each brown tablet (7) contains 75 mcg ferrous fumarate, 6 Tablet Dispensers, 28 Tablets Each, Rx only.
CODE Lot 63001H02.
RECALLING FIRM/MANUFACTURER Watson Pharmaceuticals, Inc., Corona, CA.
REASON Subpotent; ethinyl estradiol component (18 month stability).
VOLUME OF PRODUCT IN COMMERCE 21,005.
DISTRIBUTION Nationwide.

PRODUCT Tebamide Suppositories, (Trimethobenzamide HCl) 100 mg, Pediatric Suppositories, 10 count boxes, Rx Only.
CODE Lot 2137-6, Exp. 6/04.
RECALLING FIRM/MANUFACTURER G & W Labs, Inc., South Plainfield, NJ.
REASON Subpotent; benzocaine (stability).
VOLUME OF PRODUCT IN COMMERCE 36,096 boxes of 10s.
DISTRIBUTION Nationwide.

WEEK ENDING APRIL 17

PRODUCT Perphenazine Tablets, USP, 2mg, 100 count bottles and 500 count bottles, Rx only.
CODE Lot Numbers/Expiration Dates: 076092A (10/2004); 076092B (10/2004).
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, NC.
REASON Impurities/Degradation Products.
VOLUME OF PRODUCT IN COMMERCE 1.699 bottles/100 ct bottles & 144/500 ct bottles.
DISTRIBUTION Nationwide.

WEEK ENDING APRIL 24

PRODUCT Sterile Diluent for Humulin L, Humulin U and Lente Iletin, Lilly, 10 ml. Vial. Warning: Use ONLY with insulins listed on side panel.
CODE Lot Number/Expiration Date: 7SD70P (09/01/04).
RECALLING FIRM/MANUFACTURER Lilly, Eli & Co., Indianapolis, IN.
REASON Particulates: White particulates or white precipitate on vial wall which does not resuspend.
VOLUME OF PRODUCT IN COMMERCE 1,535 vials.
DISTRIBUTION Nationwide.

PRODUCT MD-Gastroview(, Diatrizoate Meglumine and Diatrizoate Sodium Solution U.S.P., 367 mg/mL Organically Bound Iodine for Gastrointestinal Radiography, 25 mL Bottle, Not for Parenteral use, Rx Only.
CODE Lot #E425A, Expiration Date: September 30, 2004.
RECALLING FIRM/MANUFACTURER Tyco Healthcare, Raleigh, NC, by letter on March 25, 2004. Firm initiated recall is ongoing.
REASON Product exceeds the Iodine/Iodide specification (9-month stability).
VOLUME OF PRODUCT IN COMMERCE 137 cases (3,425 bottles).
DISTRIBUTION Nationwide, and Columbia, SA.

PRODUCT Trihexyphenidyl Hydrochloride Tablets, USP, 5 mg, 1000 Tablet bottles, Rx only.
CODE
Lot #068062A, Exp. Date: 07/04;
Lot #123072A, Exp. Date: 07/04;
Lot #056013B, Exp. Date: 02/05.
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, NC.
REASON Mislabeled; side panel of label incorrectly indicates that each tablet contains Trihexyphenidyl HCI 2 mg rather than correctly containing Trihexyphenidyl HCI 5 mg.
VOLUME OF PRODUCT IN COMMERCE 1,525 bottles.
DISTRIBUTION Nationwide.