JUNE 2004

WEEK ENDING JUNE 12

PRODUCT
a) Eye Drops Artificial Tears, (Polyvinyl alcohol 0.5% and Povidone 0.6%), 20 mL (.67 FL OZ), over-the-counter, NDC 67234-009-01.

b) Eye Drops Allergy Relief, (Naphazoline hydrochloride 0.012% Glycerin 0.2%, Zinc Sulfate 0.25%), 20 mL (.67 LF OZ) plastic bottles, over-the-counter, NDC 67234-011-01.
c) Eye Drops, Extra Relief, (Naphazoline hydrochloride 0.012% Glycerin 0.2%, 20 mL (.67 FL OZ) plastic bottles, over-the-counter, MADE IN THE USA, NDC 67234-010-01.
d) No Drip Nasal Spray, (Oxymetazoline 0.05%), 20 mL (.67 FL OZ) plastic bottles, 12 Hour Pump Mist, over-the-counter, Made in the USA, NDC 67234-012-01.
CODE
a) Item No. 3100, All lot numbers and expiration dates;
b) Item No. 3101, All lot numbers and expiration dates;
c) Item No. 3102, All lot numbers and expiration dates;
d) All lot numbers and expiration dates.
RECALLING FIRM/MANUFACTURER Natureplex Llc, Memphis, TN.
REASON Non sterile; product manufactured under non-sterile conditions.
VOLUME OF PRODUCT IN COMMERCE 485,925 bottles.
DISTRIBUTION Nationwide.

WEEK ENDING JUNE 19

PRODUCT M.T.E.-5 Concentrated, Mixture of Five Trace Elements Additive; (Each mL providing: zinc 5 mg, copper 1 mg, manganese 0.5 mg, chromium 10 mcg, selenium 60 mg), 10 mL multidose vial, Rx only, Must be diluted before IV use; NDC 63323-029-10.
CODE Lot 130404, exp. April 2006.
RECALLING FIRM/MANUFACTURER American Pharmaceutical Partners, Inc., Melrose Park, IL.
REASON Superpotent; Selenium (12 month stability).
VOLUME OF PRODUCT IN COMMERCE 11,440 vials.
DISTRIBUTION Nationwide.

PRODUCT Orasept Antiseptic Mouthwash & Gargle (cetylpyridinium HCl 0.05% w/w), 4 fl. oz. (118 mls.) bottles, over-the-counter. NDC 55422-202-04.
CODE Lot 4B45, Expiration Date 01/06.
RECALLING FIRM/MANUFACTURER Pharmakon Laboratory, Inc., Tampa, FL.
REASON Microbial contamination (yeast and mold).
VOLUME OF PRODUCT IN COMMERCE 9,754 bottles.
DISTRIBUTION PA, GA, and CT.

PRODUCT Contac Cold + Flu Day & Night Caplets, each yellow Day caplet contains Acetaminophen 650mg, Dextromethorphan hydrobromide 30mg, and Pseudoephedrine hydrochloride 60mg and each blue Night caplet contains Acetaminophen 650mg, Diphenhydramine hydrochloride 50mg and Pseudoephedrine hydrochloride 60mg, in blister packs of 15 count Day caplets and 5 count Night caplets, over-the-counter.
CODE Lots: 3G23P exp 06/06; 3H12P exp 07/06; 3H12PA exp 07/06; 4B02P exp 01/07.
RECALLING FIRM/MANUFACTURER Glaxosmithkline, Parsippany, NJ.
REASON Mislabeled; product carton does not have pseudoephedrine warning statement directed to hypertensives and diabetics.
VOLUME OF PRODUCT IN COMMERCE 449,244 units.
DISTRIBUTION Nationwide, Bahamas and Bermuda.

PRODUCT Collagenase Santyl® OINTMENT (derived from Clostridium histolyticum), 250 units per gram, 15 gram tubes, Rx only, Knoll label: NDC 0044-5270-02; Smith & Nephew label: NDC 50484-527-15.
CODE Knoll label: Lot 0000059281, EXP 10/04; Smith+Nephew label: Lot 0000093210, EXP 6/05.
RECALLING FIRM/MANUFACTURER Advance Biofactures Corp., Lynbrook, NY, by letters dated May 26, 2004. Firm initiated recall is ongoing.
REASON Subpotent: stability.
VOLUME OF PRODUCT IN COMMERCE 54,333 tubes.
DISTRIBUTION Nationwide and Puerto Rico.

WEEK ENDING JUNE 26

PRODUCT
a) Zyprexa Tablets, (olanzapine), 15 mg, 60 count bottle, Rx only.
b) Zyprexa Tablets, (olanzapine), 20 mg, 60 count bottle, Rx only.
CODE
a) Lot Numbers-Expiration Dates: 7EJ36A-NOV 1, 2005; 7EJ38A-NOV 1, 2005; 7EJ40A-NOV 1, 2005; 7EJ43A-NOV 1,
2005; 7EG61A-SEP 1, 2005; 7EG63A-SEP 1, 2005 7EG65A -SEP 1, 2005;
b) Lot Numbers-Expiration Dates: 7EJ34A-NOV 1, 2005; 7EJ28A-NOV 1, 2005; 7EJ32A-NOV 1, 2005; 7EJ33A-NOV 1,
2005; 7EF40A-AUG 1,2005; 7ED85A-JUL 1, 2005; 7EF41A-AUG 1, 2005.
RECALLING FIRM/MANUFACTURER Burlington Drug Company, Milton, VT.
REASON Counterfeit.
VOLUME OF PRODUCT IN COMMERCE 238 bottles.
DISTRIBUTION ME, NH, NY, MA and VT

PRODUCT
a) Colgate Fluoride Toothpaste, Maximum Cavity Protection, (Sodium Monofluorophosphate 0.76% (1000ppm F) and Sodium Fluoride 0.1% (450ppm F)), packaged in 100-ml tubes, net wt. 5 oz., Regular Flavour.
b) Colgate Fluoride Toothpaste Triple Action, (1.10% Sodium Monofluorophosphate and 0.20% Triclosan) packaged in
100-ml. tubes, net wt. 5-oz.

c) Mentadent P, Fluoride Toothpaste, (0.74% Sodium Mono-Fluorophosphate), packaged in 100-ml. tubes, Net Wt 5 oz.
d) Colgate Fluoride Toothpaste, Herbal, (1.10% Sodium Monofluorophosphate, packaged in 100-ml. tubes, NET WT 5 oz.
e) Aquafresh Fluoride Toothpaste, (Sodium Monofluorophosphate 0.76% w/w), packaged in 100-ml.tubes, 5 OZ.
CODE
a) All Lots: South African labeling SKU: 458976;
b) All Lots: South African labeling SKU: 445077;
c) All Lots: South African labeling SKU: 458977;
d) All Lots: South African labeling SKU: 460361;
e) All Lots: South African labeling SKU: 418030.
RECALLING FIRM/MANUFACTURER Deals Nothing Over A Dollar, Earth City, MO.
REASON Misbranded; labeling is not in compliance with regulations.
VOLUME OF PRODUCT IN COMMERCE Approximately 50,000 tubes.
DISTRIBUTION Nationwide.

PRODUCT Prozac Pulvules (Fluoxetine Hydrochloride) Equiv. To 20 mg, 2,000 count bottles, Rx Only.
CODE Lot 7AA93P; Exp. March 1, 2006.
RECALLING FIRM/MANUFACTURER Lilly, Eli & Co., Indianapolis, IN.
REASON Labeling: missing lot number and/or expiration date.
VOLUME OF PRODUCT IN COMMERCE 1,697 bottles.
DISTRIBUTION Nationwide.

PRODUCT Zyprexa Tablets (Olanzapine) 5 mg, 1000 count bottles, Rx only.
CODE Lot 7AA35S; Exp. February 1, 2005.
RECALLING FIRM/MANUFACTURER Lilly, Eli & Co., Indianapolis, IN.
REASON Labeling: missing lot number and/or expiration date.
VOLUME OF PRODUCT IN COMMERCE 2,526 bottles.
DISTRIBUTION Nationwide.