DECEMBER 2003

WEEK ENDING DECEMBER 13

Magno-Humphries, Inc. voluntarily recalls one lot of Dixon's®, Acetaminophen 325 mg Analgesic, 100 Tablet Bottles

Magno-Humphries, Inc., Tigard, Oregon, is voluntarily recalling one lot consisting of 504 bottles of Dixon's®, APAP Acetaminophen 325 mg Analgesic Tablets, an over-the-counter drug product sold in 100 Tablet bottles with lot number 319687, Expiration Date 03/05.

The recall is effective immediately and is being undertaken because this lot contains an excess of the labeled amount of acetaminophen. The tablets contained in the mislabeled bottles are 500 mg Acetaminophen, instead of 325 mg Acetaminophen. The acetaminophen is being recalled because overdoses of acetaminophen can lead to severe health problems including liver toxicity and liver failure. The acetaminophen was sold under the Dixon's® label at retail stores and pharmacies nationwide beginning in August 2003.

Consumers who purchased bottles with lot number 319687 are urged to discontinue use of the product immediately and return it to the place of purchase for a full refund. Consumers with questions may contact Magno-Humphries, Inc., at 1-800-935-6737.

Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/medwatch/index.html.

PRODUCT Lipitor tablets (Atorvastatin Calcium), 10 mg, Rx only, 5000 Tablets. Important - This package for pharmacy stock use.

CODE Lot 1609V Expiration July 2004.
RECALLING FIRM/MANUFACTURER Breckenridge Trading Company, Berlin, CT.
REASON Counterfeit product.
VOLUME OF PRODUCT IN COMMERCE 20/5000 bottles.
DISTRIBUTION OH.

PRODUCT
a) The Skin Culture One Day Peeling Treatment. 6 Treatments: 6 Cerate 39XXX, 6 Normalizer Applicators, Jar.
b) Skin Culture 2 Peeling Treatment, Skin Creams, The 6 Day Cosmetic Facial Treatment Kit.

c) Skin Culture 3 Peeling Treatment, Skin Creams. The 6 Day Cosmetic Facial Treatment Kit.
d) Skin Culture 4 Peeling Treatment, Skin Creams. The 6 Day Cosmetic Facial Treatment Kit.
CODE
a) Lots 11132, and 11829;
b) Lot 27652;
c) Lot 28132;
d) Lot 37522.
RECALLING FIRM/MANUFACTURER Skin Culture Institute, Inc., New York, NY.
REASON Misbranding: Product fails to contain declared ingredient Resorcinol and is subpotent for its sulfur ingredient.
VOLUME OF PRODUCT IN COMMERCE Approximately 4,000 jars.
DISTRIBUTION Nationwide.

PRODUCT Novocol Octocaine 50 Lidocaine Hydrochloride 2% with Epinephrine 1:50,000 Injection (Lidocaine Hydrochloride and Epinephrine Injection, USP). 50 cartridges/1.8 mL, For Dental Block and Infiltration Only, Rx Only. Also sold under brands as: Henry Schein Lidocaine HCI 2% and Epinephrine 1:50,000 Injection, Super-Dent Lidocaine Hydrochloride 2% and Epinephrine 1:50,000.
CODE Lot No/Exp date: 2058 (12/03), 2058A (12/03), 2073 (12/03), 2073A (12/03), 2079 (1/04), 2094 (1/04), 2094A (1/04), 2094B (1/04), 2116A (1/04), 2150 (4/04), and 2150A (04/04). Lot No 2095 was shipped to foreign accounts only.
RECALLING FIRM/MANUFACTURER Septodont Inc., New Castle, DE.
REASON Subpotent for Epinephrine ingredient.
VOLUME OF PRODUCT IN COMMERCE 32,748 boxes.
DISTRIBUTION Nationwide, Armenia, Chile, and Taiwan.

PRODUCT Pert Plus, 2 in 1 Dandruff Control Shampoo plus Conditioner (Pyrithione zinc 1.0%), 13.5 Fl. Oz. (400 mL), 12 bottles per case.

CODE Lot Numbers: 32765395XA and 32885395XA.
RECALLING FIRM/MANUFACTURER The Proctor & Gamble Company, Cincinnati, OH.
REASON Subpotent for Pyrithione Zinc ingredient.
VOLUME OF PRODUCT IN COMMERCE 1,374 cases.
DISTRIBUTION Nationwide.

WEEK ENDING DECEMBER 20

PRODUCT Morphine Sulfate Injection, USP, 30mg (1 mg/ml), 30 mL Single-dose Abboject PCA Vial, Rx Only.
CODE Lot No/Exp. Date: 05-220-DK (01 June 2005).
RECALLING FIRM/MANUFACTURER Abbott Labs, North Chicago, IL.
REASON Mispackaging; A vial labeled as Meperidine HCI Injection, USP 10 mg/ml was found in a sealed holding carton labeled to contain Morphine Sulfate Injection, USP 1 mg/ml.
VOLUME OF PRODUCT IN COMMERCE 83,550 units.
DISTRIBUTION Nationwide.

PRODUCT Bactroban Nasal( Ointment (Mupirocin Calcium Ointment 2 %), 1.0 gram Single-Use Tubes, Rx Only.

CODE Lot SKAK; Expiration date: 10/04.
RECALLING FIRM/MANUFACTURER GlaxoSmithKline, Zebulon, NC.
REASON Superpotent; Stability (6 month).
VOLUME OF PRODUCT IN COMMERCE 12,500 cartons (10 tubes/carton).
DISTRIBUTION Nationwide.

PRODUCT Cold & Hot Therapy Pain Relief Cream, Extra Strength (Methyl Salicylate 30% and Menthol 10%) Net Weight 1.25 oz. (35.4g). Sold under other brands as: 1) Brooks Pharmacy Cold and Hot Extra Strength Therapy Pain Relief Cream, Net Weight 1.25 oz. (35.4g); 2) Pathmark Extra Strength Cold and Hot Therapy Pain Relief Cream, Net Weight 1.25 oz. (35.4g); 3) Extra Strength Cold & Hot pain relief cream, Net Wt. 3 oz. (85 g).
CODE Code/Exp. date: 2H06A/August 2004; 2H29C/August 2004; 2113B/September 2004; 2117B/October 2004; 2K07B/November 2004; 3A14A/January 2005; 3B26B/ February 2005; 3C24D/March 2005; 3D22A/April 2005; 3E19B/March 2005; 3F19E/June 2005; 3G09C/July 2005; 3G16A/July 2005; 3H25D/August 2005; 3126A/September 2005.
RECALLING FIRM/MANUFACTURER Qualis Inc., Des Moines, IA.
REASON Subpotent; (Methyl Salicylate) 12-month stability.
VOLUME OF PRODUCT IN COMMERCE 11,868 (1.25-oz.) & 35,724 (3-oz.) tubes.
DISTRIBUTION Nationwide.