JANUARY 2007

WEEK ENDING JANUARY 6

PRODUCT
Ketalar® CIII, ketamine hydrochloride for injection, USP, 10mg/mL, 20mL steri-vial®. 10 vials per package. Rx, NDC 61570-581-10, 
CODE Lot Nos.: 29008 (exp 02/09), 30735 (exp 03/09), 31573 (exp 03/09), 32268 (exp 04/09), 32270 (exp 04/09), 32738 (exp 05/09)
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals Inc., Bristol, TN., 
Manufacturer: Parkedale Pharmaceuticals, Inc., Rochester, MI. 
REASON Lack of sterility assurance due to vial defect.
VOLUME OF PRODUCT IN COMMERCE 5,567 units (55,670 vials)
DISTRIBUTION Nationwide and PR

PRODUCT
a) Thyro-Tab 0.025 mg, packaged in 150,000-tablet bulk drums
intended for repackaging, RX,
b) Levothroid (levothyroxine sodium tablets, USP), 25 mcg,
packaged in 100 and 1,000-tablet bottles, RX, NDC 0456-1320-01 (100-tab.) and
NDC 0456-1320-00 (1,000-tab.), 
CODE
a) Lot: HA35305;
b) Lot 010648 (100-tab.) and Lot 010652 (1,000-tab.), exp. January 2007
RECALLING FIRM/MANUFACTURER Lloyd Inc of Iowa, Shenandoah IA,
REASON Subpotent (9-month stability)
VOLUME OF PRODUCT IN COMMERCE a) 1,947,208 bulk tablets;
b) 14,126/100-tab. bottles and 486/1,000-tab. bottles
DISTRIBUTION Nationwide

PRODUCT Ketalar® CIII, ketamine hydrochloride for injection, USP, 10mg/mL, 20mL steri-vial®. 10 vials per package. Rx, 
CODE Lot Nos.: 35150 (exp 07/09), 35151 (exp 07/09)
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals Inc., Bristol, TN, 
Manufacturer: Parkedale Pharmaceuticals, Inc., Rochester, MI. 
REASON Lack of sterility assurance due to vial defect.
VOLUME OF PRODUCT IN COMMERCE 18,950 vials
DISTRIBUTION Nationwide and PR

PRODUCT
Pink Eye Relief Drops, Homeopathic Remedy, (homeopathic): Euphrasia HPUS 6X, Hepar Sulphuris HPUS 12X, Belladonna HPUS 6X, 0.4 fl. oz. bottles, Alleviates inflammation, pain, redness and water discharge, packaged under the following labels:
1) select brand, Distributed By: Select Brand Distributors, NDC 15127-005-04;
2) Eckerd, Distributed by : Eckerd Corporation d/b/a/ Eckerd Pharmacy;
3) Brooks, Distributed By; Maxi Drug Inc., d/b/a Brooks Pharmacy;
4) Premier Value, Distributed By Chain Drug Consortium, LLC, NDC 68016-107-07;
5) Equaline, Distributed by Albertsons, Inc., NDC 41163-107-07,
CODE 150117, 150215, 151215, 151014, 1510141, 151102, 151105, 151106, 151110, 1511101, 1511102, 151204, 151212, 1512121, 1512123, 160101, 1601011, 160112, 160212
RECALLING FIRM/MANUFACTURER Pharmaceuticals, Inc. dba Wendt Laboratories, Inc, Belle Plaine, MN,
REASON Lack of assurance of sterility; not manufactured in accordance with current Good Manufacturing Practices Regulations
VOLUME OF PRODUCT IN COMMERCE 59,916 bottles
DISTRIBUTION Nationwide

PRODUCT Dicyclomine Hydrochloride Tablets, USP, 20 mg, 100 Tablet bottle, Rx only, NDC 0143-1227-01, 
CODE Lot number WWCN 59401A, Exp. 05/09 WW27 embossed on tablet.
RECALLING FIRM/MANUFACTURER West-Ward Pharmaceutical Corp., Eatontown, NJ,
REASON Subpotent (12-month stability)
VOLUME OF PRODUCT IN COMMERCE 28,112 bottles of 100 count
DISTRIBUTION Nationwide

PRODUCT PREMPRO™ (conjugated estrogens/medroxyprogesterone acetate tablets) 0.3 mg/1.5 mg, Rx only, cartons of 3 EZ-DIAL® Dispensers, NDC 0046-0938-09, 
CODE B14984 (exp. 1/07)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Philadelphia, PA, 
Manufacturer: Wyeth Pharmaceuticals, Inc. Rouses Point NY. 
REASON Failed USP Dissolution Requirement.
VOLUME OF PRODUCT IN COMMERCE 50,302 cartons (each carton contains 3 EZ-DIAL dispensers)
DISTRIBUTION Nationwide and PR

WEEK ENDING JANUARY 13

PRODUCT Ranitidine HCl Tablets, USP 150 mg packaged in a blister card of 30 tablets, NDC 66689-014-01, 
CODE Lot number: 602570
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vista Pharm, Inc., Largo, FL,
Manufacturer: Wockhardt USA, Inc., Warwick, NY. 
REASON Failed Impurity Specification.
VOLUME OF PRODUCT IN COMMERCE 4,80 tablets
DISTRIBUTION AZ and NC

WEEK ENDING JANUARY 20

Ebek, Inc. Issues Nationwide Recall of Liviro3, a Product Marketed as a Dietary Supplement

Ebek, Inc., 3921 Wilshire Boulevard, Suite 307, Los Angeles, Ca 90010, announced today that it is conducting a nationwide recall of the Company's supplement product sold under the name Liviro3. The Company found the product contains tadalafil, an FDA-approved drug used to treat erectile dysfunction (ED), making Liviro3 an unapproved drug. FDA advised that this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. 

The recalled Liviro3 is sold in 10-tablet boxes or 20-tablet plastic bottles. The product label warns consumers with high blood pressure not to ingest the product but does not state it contains tadalafil.

Consumers who have Liviro3 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. 

Consumers should return any unused Liviro3, for a refund of the full purchase price or price for the unused portion, to the retail location where it was purchased or to Ebek directly at (213) 480-0316 or by email at recall@liviro.com to receive further instructions for returning the product or with any questions.

WEEK ENDING JANUARY 27

PRODUCT Betamethasone Acetate/Sodium Phosphate Injectable, 6mg/mL, 10 mL vial, Rx, 
CODE Lots: 11272006@13, exp. 5/26/07; 12042006@9, exp. 6/2/07
RECALLING FIRM/MANUFACTURER MED South Pharmacy DBA Partners In Care, Pelham, AL
REASON Adverse reactions due to formula change.
VOLUME OF PRODUCT IN COMMERCE 239 vials
DISTRIBUTION AL, AR, FL, GA, LA, and TN

Counterfeit Liviro3 Discovered After Recall Announcement

Ebek, Inc., 3921 Wilshire Boulevard, Suite 307, Los Angeles, Ca 90010. Ebek, Inc. was informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Liviro3 samples found the product contains tadalafil, an FDA-approved drug used to treat erectile dysfunction (ED), making Liviro3 an unapproved drug. 

Consumers who have either the genuine or counterfeit Liviro3 product in their possession should stop using it immediately and contact their physician if they have experienced any problem that may be related to taking either of these products.

Consumers should return any unused genuine Ebek Liviro3, for a full refund of the full price or price for the unused portion, to the retail location where it was purchased or to Ebek directly at (213) 480-0316 or by email at recall@liviro.com to receive further instructions for returning the product or with any questions. Consumers are requested to send any unused counterfeit product to Ebek, pending further instruction. Ebek will not issue a refund for counterfeit product but will appreciate receiving the counterfeit product for further investigation.

Below is a diagram explaining how a consumer may tell if they have genuine vs. counterfeit Liviro3: