JULY 2004

WEEK ENDING JULY 3

PRODUCT Medical Air, USP, Air, Compressed, Various cylinder sizes.
CODE DATE LOT CODE 10/1/2003 WV00Q274A 10/2/2003 WV00Q275A 10/6/2003 WV00Q279A 10/9/2003 WV00Q282A 10/9/2003 WV00Q282B 10/9/2003 WV00Q282C 10/10/2003 WV00Q283A 10/13/2003 WV00Q286A 10/13/2003 WV00Q286B 10/13/2003 WV00Q286C 10/13/2003 WV00Q286D 10/15/2003 WV00Q288A 10/16/2003 WV00Q289A 10/20/2003 WV00Q293A 10/21/2003 WV00Q294A WV00Q294B WV00Q294C 10/24/2003 WV00Q297A 10/27/2003 WV00Q300A WV00Q300B WV00Q300C WV00Q300D 10/28/2003 WV00Q301A 10/30/2003 WV00Q303A WV00Q303B 11/4/2003 WV00Q308A WV00Q308B WV00Q308C WV00Q308D 11/5/2003 WV00Q309A WV00Q309B 11/6/2003 WV00Q310A 11/7/2003 WV00Q311A 11/12/2003 WV00Q316A 11/13/2003 WV00Q317A 11/14/2003 WV00Q318A WV00Q318B WV00Q318C WV00Q318D WV00Q318E 11/17/2003 WV02Q321A 11/18/2003 WV00Q322A 11/20/2003 WV00Q324A WV00Q324B 11/24/2003 WV00Q328A WV00Q328B 11/25/2003 WV00Q329A WV00Q329B WV00Q329C WV00Q329D 12/2/2003 WV00Q336A WV00Q336B 12/3/2003 WV00Q337A 12/8/2003 WV00Q342A WV00Q342B WV00Q342C WV00Q342D WV00Q342E 12/9/2003 WV00Q343A WV00Q343B 12/10/2003 WV00Q344A 12/12/2003 WV00Q346A WV00Q346B WV00Q346C 12/15/2003 WV00Q349A 12/16/2003 WV00Q350A WV00Q350B 12/17/2003 WV00Q351A 12/23/2003 WV00Q357A WV00Q357B WV00Q357C WV00Q357D 12/29/2003 WV00Q363A 12/30/2003 WV00Q364A 12/31/2003 WV00Q365A 1/5/2004 WV00R005A WV00R005B 1/6/2004 WV00R006A 1/7/2004 WV00R007A WV00R007B 1/8/2004 WV00R008A 1/12/2004 WV00R012A WV00R012B 1/14/2004 WV00R014A WV00R014B 1/15/2004 WV00R015A 1/16/2004 WV00R016A WV00R016B 1/20/2004 WV00R020A 1/21/2004 WV00R021A WV00R021B 1/22/2004 WV00R022A WV00R022B 1/23/2004 WV00R023A 1/28/2004 WV00R028A WV00R028B WV00R028C WV00R028D 1/29/2004 WV00R029A WV00R029B 2/3/2004 WV00R034A WV00R034B WV00R034C 2/4/2004 WV00R035A WV00R035B 2/5/2004 WV00R036A 2/6/2004 WV00R037A 2/9/2004 WV00R040A 2/10/2004 WV00R041A 2/11/2004 WV00R042A WV00R042B 2/12/2004 WV00R043A 2/16/2004 WV00R047A WV00R047B WV00R047C WV00R047D WV00R047E 2/17/2004 WV00R048A 2/18/2004 WV00R049A WV00R049B 2/19/2004 WV00R050A 2/20/2004 WV00R051A WV00R051B 2/27/2004 WV00R058A WV00R058B 2/28/2004 WV00R059A WV00R059B WV00R059C WV00R059D 3/1/2004 WV00R061A WV00R061B WV00R061C 3/2/2004 WV00R062A 3/3/2004 WV00R063A WV00R063B 3/5/2004 WV00R065A 3/8/2004 WV00R068A 3/10/2004 WV00R070A 3/12/2004 WV00R072A WV00R072B WV00R072C 3/15/2004 WV00R075A 3/16/2004 WV00R076A 3/17/2004 RV00R077A 3/19/2004 WV00R079A WV00R079B 3/22/2004 WV00R082A WV00R082B 3/25/2004 WV00R085A WV00R085B WV00R085C WV00R085D 3/29/2004 WV00R089A WV00R089B WV00R089C 3/30/2004 WV00R090A 4/1/2004 WV00R092A WV00R092B WV00R092C 4/5/2004 WV00R096A WV00R096B WV00R096C WV00R096D.
RECALLING FIRM/MANUFACTURER Southern California Airgas, Inc., Lakewood, CA.
REASON Good Manufacturing Practice (GMP) Deviation.
VOLUME OF PRODUCT IN COMMERCE 4,175 cylinders.
DISTRIBUTION CA, NV, AZ.

PRODUCT Advicor Extended-Release Tablets (Niacin extended release and Lovastatin tablets), 500 mg/20 mg, 90 tablet bottles, NDC 60598-006-90.
CODE Lot 0303100001 Exp. 1/05.
RECALLING FIRM/MANUFACTURER Kos Pharmaceuticals, Co.
REASON Failed Content Uniformity testing.
VOLUME OF PRODUCT IN COMMERCE 3,864 bottles.
DISTRIBUTION Nationwide.

PRODUCT Bisacodyl 10mg Laxative Suppositories, Each containing 10mg Bisacodyl USP, 12 suppositories, NDC 58298-130-12. This product was also sold under two other brand labels: (1) The Magic Bullet, units of 12 and 100, NDC 57648-002-12, and NDC 57648-002-01 and (2) Qualitest, units of 12, NDC 0603-8086-11.

CODE All Un-expired Lot Numbers.
RECALLING FIRM/MANUFACTURER Elge, Inc, Rosenberg, TX.
REASON Stability Failure-Bisacodyl USP.
VOLUME OF PRODUCT IN COMMERCE 70,983 units.
DISTRIBUTION Nationwide.

WEEK ENDING JULY 10

PRODUCT Phenytoin Oral Suspension USP (125MG/5ML), 8 oz bottles (237mL), Rx only, NDC #0472-0067-08.
CODE Lot Number Expiration Date RP2715 EXP 09/04 RS2744 EXP 10/04 RS2745 EXP 11/04 RA3036 EXP 11/04 RA3037 EXP 11/04 RA3038 EXP 11/04 RA3039 EXP 11/04 RB3089 EXP 12/04 RB3090 EXP 12/04 RD3159 EXP 01/05 RD3160 EXP 01/05 RD3161 EXP 01/05 RF3211 EXP 02/05 RF3212 EXP 02/05 RH3263 EXP 02/05 RH3264 EXP 02/05 RH3265 EXP 03/05 RH3266 EXP 03/05 RL3407 EXP 04/05 QL3478 EXP 04/05 QL3479 EXP 04/05 QL 3480 EXP 04/05.
RECALLING FIRM/MANUFACTURER Alpharma USPD, Baltimore, MD.
REASON Product not manufactured as per approved method (additional unapproved mixing).
VOLUME OF PRODUCT IN COMMERCE 317,952 bottles.
DISTRIBUTION Nationwide.

PRODUCT Cortisporin -TC Otic Suspension, Each mL contains: (Colistin sulfate equivalent to 3mg of colistin base activity, Neomycin sulfate equivalent to 3.3mg neomycin base activity, Hydrocortisone acetate 10mg (1%), Thonzonium bromide 0.5mg (0.05%)), 10 mL bottle with dropper, Rx Only, Sterile, NDC 61570-090-10.
CODE Lot Number: 00433M, Expiration: 07/04.
RECALLING FIRM/MANUFACTURER King Pharmaceuticals, Inc., Bristol, TN.
REASON Lack of Assurance of Sterility; product cap may not have been adequately tightened when assembled to bottle.
VOLUME OF PRODUCT IN COMMERCE 26,991 bottles.
DISTRIBUTION Nationwide and Puerto Rico.

PRODUCT
a) M.T.E.-4 Mixture of Four Trace Elements Additive, Preservative Free, Each mL providing (Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg and Chromium 4 mcg), 3 mL and 10 mL single dose vials, Rx only, For IV Use Only After Dilution, NDC 63323-081-03 (3 mL) and NDC 63323-081-10 (10 mL).
b) M.T.E.-4 Mixture of Four Trace Elements Additive, Each mL providing (Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, Chromium 4 mcg), 30 mL multidose vials, Rx only, For IV Use Only After Dilution, 60173; NDC 63323-087-30.
c) M.T.E.-4 Concentrated Mixture of Four Trace Elements Additive, Preservative Free, Each mL providing (Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg and Chromium 10 mcg), 1 mL single dose vials, Rx only, For IV Use
Only After Dilution; NDC 63323-094-01.
d) M.T.E.-4 Concentrated, Mixture of Four Trace Elements Additive, Each mL providing (Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg), 10 mL multidose vials, Rx only, For IV Use Only After Dilution; NDC 63323-098-10.
e) M.T.E.-5 Mixture of Five Trace Elements Additive, Preservative Free, Each mL providing (Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, Chromium 4 mcg and Selenium 20 mcg), 10 mL single dose vials, Rx only, Must be diluted before IV use; NDC 63323-018-10.
f) M.T.E.-5 Concentrated, Mixture of Five Trace Elements Additive, Each mL providing (Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, chromium 4 mcg, Selenium 20 mcg), 10 mL multidose vials, Rx only, Must be diluted before IV use, NDC 63323-029-10.
g) M.T.E.-6 Mixture of Six Trace Elements Additive, Preservative Free, Each mL providing (Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, Chromium 4 mcg, Selenium 20 mcg and Iodide 25 mcg), 10 mL single dose vials, Rx only,
Must be diluted before IV use, NDC 63323-020-10.
h) M.T.E.-7 Mixture of Seven Trace Elements Additive, Preservative Free, Each mL providing (Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, Chromium 4 mcg, Selenium 20 mcg, Iodide 25 mcg and Molybdenum 25 mcg),10 mL single dose vials, Rx only, Must be diluted before IV use; NDC 63323-014-10.
i) Neotrace-4 Neonatal Mixture of Four Trace Elements Additive, Preservative Free Eac, Each mL providing (Zinc 1.5 mg, Copper 0.1 mg, Manganese 25 mcg and Chromium 0.85 mcg) 2 mL single dose vials, Rx only, For IV use only after dilution; NDC 63323-141-02.
j) Pedtrace-4 Pediatric Mixture of Four Trace Elements Additive, Preservative Free, Each mL providing (Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg and Chromium 1 mcg), 10 mL single dose vials, Rx only, For IV use
only after dilution; NDC 63323-138-10.
k) P.T.E.-4 Pediatric Mixture of Four Trace Elements Additive, Preservative Free, Each mL providing (Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg and Chromium 1mcg) 3 mL single dose vials, Rx only, For IV use only after
dilution, NDC 63323-082-03.
l) P.T.E.-5 Pediatric Mixture of Five Trace Elements Additive, Preservative Free, Each mL providing (Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, Chromium 1mcg and Selenium 15 mcg), 3 mL single dose vials, Rx only, For
IV use only after dilution, NDC 63323-144-03.
CODE
a) 3 mL vials: Lot 111193, exp. 12/31/04; Lot 120643, exp. 05/31/05; Lot 121426, exp. 12/31/05; 10 mL vials: Lot 111107, exp. 11/30/04; Lot 120593, exp. 05/31/05; Lot 121265, exp. 10/31/05;
b) Lot 111252, exp. 12/31/04; Lot 120605, exp. 5/31/05; Lot 130232, exp. 03/31/06;
c) Lot 121225, exp. 10/31/04;
d) Lot 111241, exp. 12/31/04;
e) Lot 120604, exp. 05/31/04; Lot 121034, exp. 08/31/04;
f) Lot 111135, exp. 11/30/04;
g) Lot 120762, exp. 06/30/04;
h) Lot 120586, exp. 05/31/04;
i) Lot 111250, exp. 06/30/04; Lot 120615, exp. 11/30/04; Lot 121088, exp. 03/31/05; Lot 130300, exp. 09/30/05;
j) Lot 120763, exp. 06/30/04; Lot 130497, exp. 05/31/05;
k) Lot 120730, exp. 06/30/04;
l) Lot 120413, exp. 10/31/04; Lot 120819, exp. 01/31/05; Lot 130288, exp. 09/30/05.
RECALLING FIRM/MANUFACTURER American Pharmaceutical Partners, Inc., Melrose Park, IL.
REASON Stability; lack of assurance that product potency will be maintained through labeled expiration.
VOLUME OF PRODUCT IN COMMERCE 2,128,940 vials.
DISTRIBUTION Nationwide and Internationally.

WEEK ENDING JULY 17

PRODUCT Maxifed DM Tablets, Each sustained-release tablet contains: Guaifenesin 580mg, Pseudoephedrine HCl 60mg, Dextromethorphan HBr 30mg, 100 count bottles, Rx Only,
NDC 58605-626-01.
CODE 3M05.
RECALLING FIRM/MANUFACTURER Pharmakon Laboratory, Inc, Tampa, FL.
REASON The caplets are embossed as ìMAXIPHEN DMî rather than ìMAXIFED DMî.
VOLUME OF PRODUCT IN COMMERCE 2,010.
DISTRIBUTION Nationwide.

PRODUCT Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5mg/500mg per 15mL, unit dose cups, For Institutional Use Only, Rx Only, a) NDC 0121-4655-15, b) NDC 0121-0655-15.
CODE a) Lot numbers 2L33, 3B53, 3D03, 3F06, 3F11, 3H36 & 3J48 and b) Lot numbers 3L05 & 4A45.
RECALLING FIRM/MANUFACTURER Pharmaceutical Associates, Inc, Greenville, SC.
REASON Stability failure (hydrocodone).
VOLUME OF PRODUCT IN COMMERCE 1,350,150 unit dose cups.
DISTRIBUTION Nationwide.

PRODUCT Loxitane Capsules, (Loxapine Succinate) 10 mg base, 100 count bottles, Rx only, NDC 52544-495-01.
CODE 49501K02, Expiration Date 9/2005.
RECALLING FIRM/MANUFACTURER Watson Laboratories, Inc, Corona, CA.
REASON Capsule Defect; split or broken capsules.
VOLUME OF PRODUCT IN COMMERCE 6,480.
DISTRIBUTION Nationwide.

PRODUCT PREMARIN (conjugated estrogens tablets USP), 1.25 mg, 1000-count bottles, Rx only, NDC 0046-0866-91.

CODE Lots: A28811 and A49547, Exp Date: May 2005.
RECALLING FIRM/MANUFACTURER Richmond Division of Wyeth, Richmond, VA.
REASON Dissolution Failure; (18 month stability).
VOLUME OF PRODUCT IN COMMERCE 16,871 bottles (1000s).
DISTRIBUTION Nationwide.

WEEK ENDING JULY 24

PRODUCT Aspirin, Enteric Coated Tablets, 81 mg, 120 count bottles, Adult Low Strength Pain Reliever, BROOKS brand. Also sold under the following brand names: GOOD SENSE brand, Perrigo, NDC 0113-0535-76; Longs brand, NDC 12333-9537-1; Perfect Choice brand, NDC 41226-535-76; SAFEWAY brand, NDC 21130-535-76; Shop Rite brand; Equate brand, NDC 0113-1535-76; FOOD LION brand, NDC 55316-535-76; Brite-Life brand, NDC 24385-535-76; Good Neighbor Pharmacy brand, Distributed by Bergen Brunswig Drug, NDC 24385-535-76; Valu-Rite brand, NDC 49348-756-53; Family Pharmacy brand, NDC 52735-761-23; and Leader brand.
CODE Lot numbers 2DE0148 and 2DE0584; EXP. 01/05.
RECALLING FIRM/MANUFACTURER Perrigo Co., Allegan, MI.
REASON Dissolution failure; Enteric coating.
VOLUME OF PRODUCT IN COMMERCE 99,252 bottles.
DISTRIBUTION Nationwide.

WEEK ENDING JULY 31

PRODUCT FLORIDAíS BEST NATURAL SINUS RELIEF, (Purified Water, Saline, C-A-W Water, Eucalyptus Oil (0.7 Parts Per Mil), Peppermint), 1.5 OZ bottles.

CODE All products shipped prior to March 24, 2004. Product is uncoded.
RECALLING FIRM/MANUFACTURER JLT Industries, Longwood, FL.
REASON Microbial Contamination; product contains mold and yeast.
VOLUME OF PRODUCT IN COMMERCE Approximately 100 bottles.
DISTRIBUTION Nationwide.

PRODUCT
a) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 25mcg, 100 and 1000 count bottles, Rx only, NDC
52604-5025-1 and NDC 52604-5025-2.

b) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 50mcg, 100 and 1000 count bottles, Rx only, NDC
52604-5050-1 and NDC 52604-5050-2.
c) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 100mcg, 100 and 1000 count bottles, Rx only, NDC
52604-5100-1 and NDC 52604-5100-2.

d) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 125mcg, 100 count bottles, Rx only,

NDC 52604-5125-1.
e) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 137mcg, 100 and 1000 count bottles, Rx only, NDC
52604-5137-1 and NDC 52604-5137-2.

f) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 150mcg, 100 and 1000 count bottles, Rx only, NDC
52604-5150-1 and NDC 52604-5150-2.
g) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 175mcg, 100 and 1000 count bottles, Rx only, NDC
52604-5175-1 and NDC 52604-5175-2.
h) Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 200mcg, 100 and 1000 count bottles, Rx only, NDC
52604-5200-1 and NDC 52604-5200-2.
CODE
a) 100 count: Lot No. 8210, expiration 09/04 ---- 1000 count: Lot No. 8211, expiration 09/04;
b) 100 count - Lot No. 8122, Exp Date 07/04; Lot No. 8125, Exp Date 07/04; Lot No. 8127, Exp Date 07/04;
Lot No. 8129, Exp Date 07/04, Lot No. 8132, Exp Date 07/04, Lot No. 8131, Exp Date 07/04 -----
1000 count - Lot No.- Expiration: Lot No. 8124, Exp Date 07/04; Lot No. 8126, Exp Date 07/04; Lot No. 8128, Exp
Date 07/04; Lot No. 8130, Exp Date 07/04;
c) 100 count - Lot No. 8079, Exp Date 07/04, Lot No. 8136, Exp Date 07/04 ---- 1000 count - Lot No. 8137, Exp Date
07/04; Lot No. 8138, Exp Date 07/04; Lot No. 8111, Exp Date 07/04;
d) Lot No. 8087, Expiration 07/04;
e) 100 count - Lot No. 8105, Exp 07/04; Lot No. 8107, Exp 07/04 ---- 1000 count - Lot No. 8104, Exp 07/04;
Lot No. 8106, Exp 07/04;
f) 100 count - Lot No. 8264, Exp 09/04; Lot No. 8266, Exp 09/04; Lot No. 8268, Exp 10/04; Lot No. 8270,
Exp 10/04; Lot No. 8377, Exp 12/04, Lot No. 8090, Exp 07/04; Lot No. 8092, Exp 07/04; Lot No. 8094,
Exp 07/04; Lot No. 8155, Exp 08/04; Lot No. 8156, Exp 08/04, Lot No. 8157, Exp 08/04; Lot No. 8158,
Exp 07/04, Lot No. 8159, Exp 07/04 ---- 1000 count - Lot No. 8265, Exp 09/04; Lot No. 8267,
Exp 09/04; Lot No. 8269, Exp 10/04; Lot No. 8376, Exp 12/04; Lot. No. 8263 , Exp 09/04, Lot No. 8089,
Exp 07/04; Lot No. 8091, Exp 07/04; Lot No. 8093, Exp 07/04;
g) 100 count - Lot No. 8121, Exp 10/04; Lot No. 8297, Exp 10/04; Lot No. 8115, Exp 07/04; Lot No. 8116,
Exp 07/04; Lot No. 8117, Exp 07/04; Lot No. 8118, Exp 07/04 ----- 1000 count - Lot No. 8119,
Exp 10/04; Lot No. 8120, Exp 10/04;
h) 100 count - Lot No. 8256, Exp 09/04; Lot No.8258, Exp 09/04; Lot No. 8260, Exp 09/04; Lot No. 8096,
Exp 07/04; Lot No. 8098, Exp 07/04; Lot No. 8100, Exp 07/04; Lot No. 8101, Exp 07/04 -----1000 count - Lot No. 8255, Exp 09/04; Lot No. 8257, Exp 09/04; Lot No. 8259, Exp 09/04; Lot No. 8095, Exp 07/04; Lot No. 8097, Exp 07/04; Lot No. 8099, Exp 07/04.
RECALLING FIRM/MANUFACTURER King Pharmaceuticals, Inc., Bristol, TN.

REASON Stability, inability to maintain stability through labeled expiration.
VOLUME OF PRODUCT IN COMMERCE 992,428 bottles.
DISTRIBUTION Nationwide and Puerto Rico.

PRODUCT Enalapril Maleate Tablets USP, 5 mg, 100 and 1000 count bottles, Rx only, NDC 0172-4196-60 and 0172-4196-80.

CODE Lot no Exp. date. 108684VA 10/2004; 108684VB 10/2004.
RECALLING FIRM/MANUFACTURER IVAX Pharmaceuticals, Miami, FL.
REASON Subpotent; 18 month stability.
VOLUME OF PRODUCT IN COMMERCE 19,125 bottles.
DISTRIBUTION Nationwide.

PRODUCT Urimax, Urinary Antiseptic Tablets, Each tablet contains: (Methenamine 81.6mg, Sodium Biphosphate 40.8mg, Phenyl Salicylate 36.2mg, Methylene Blue 10.8mg, Hyoscyamine Sulfate 0.12mg), 100 count bottles, Rx only, NDC 64731-860-01.
CODE Lot# 312032, Expiration Date: 02/05 & Lot# 401071, Expiration Date: 01/05.
RECALLING FIRM/MANUFACTURER Xanodyne Pharmaceuticals, Inc., Florence, KY.
REASON Disintegration failure.
VOLUME OF PRODUCT IN COMMERCE 7,561 bottles of 100 tablets (756,100 tablets).
DISTRIBUTION Nationwide.