APRIL 2005

APRIL 2005

WEEK ENDING APRIL 2

PRODUCT Lorazepam Intensol Oral Concentrate USP, 2 mg per mL, 30 mL bottle and dropper, Rx only, NDC 0054-3532-44.
CODE Lots 456878A, 457086A, 456856A, 456857A, 457016A, 457087A, 457088A, 457089A, 457425A, 457426A, 457427A, 457474A, 457549A, 457740A, 457741A.
RECALLING FIRM/MANUFACTURER Roxane Laboratories, Inc., Columbus, OH
REASON Degradation Failure; 3 month stability.
VOLUME OF PRODUCT IN COMMERCE 113,465 bottles.
DISTRIBUTION Nationwide.

PRODUCT DORNASE ALPHA PLUMOZYME Inhalation Solution in 2.5 mg/mL ampule, a recombinant human deoxyribonuclease (rhDNase), Rx only, The product is supplied on a single card containing 6 plastic ampoules that are joined together, NDC #50242-100-40. CODE Lot number L-14222, Exp. date is October 2006.
RECALLING FIRM/MANUFACTURER Genentech, Inc, South San Francisco, CA
REASON Lack of Assurance of Sterility: When a single ampule is separated from the adjacent ampoules by the user, minor leaks may occur.
VOLUME OF PRODUCT IN COMMERCE 50,400 units.
DISTRIBUTION Nationwide.

PRODUCT Prempro (conjugated estrogens/medroxyprogesterone acetate), 0.3mg/1.5 mg tablets, in EZ dial dispenser containing 28 tablets. NDC #0046-0938-08. Firm on label: Wyeth Pharmaceuticals, Philadelphia, PA.
CODE A87961, Exp. 12/2005.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richmond Division of Wyeth, Richmond, VA
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY.
REASON Dissolution failure.
VOLUME OF PRODUCT IN COMMERCE 19,448 cartons x 3 EZ dial packs.
DISTRIBUTION Nationwide.

PRODUCT
a) 5% Benzoyl Peroxide Gel packaged in 1-oz. tubes, 12 per case, OTC, under the following private labels: (1)Schnucks;

(2) Harris Teeter;
(3) Finast;

(4) and Quality Choice.
b) Invisible Acne Cream (Benzoyl Peroxide 10%), 1-oz. tubes, 12 per case, OTC, under the following private labels:

(1) Western Family Maximum Strength Invisible Acne Cream;

(2) Meijer Invisible Acne Cream Maximum Strength;

(3) Stop & Shop Maximum Strength Invisible Acne Cream;

(4) Best Yet Absolute Elements Maximum Strength Invisible Acne Cream;

(5) Premier Value Maximum Strength Invisible Acne Cream;

(6) Finast Maximum Strength Invisible Acne Cream;

(7) Personal Expressions Vanishing Acne Cream;

(8) HyVee Maximum Strength Invisible Acne Cream;

(9) Schnucks Maximum Strength Invisible Acne Cream;

(10) Leader Maximum Strength Invisible Acne Cream;

(11) Quality Choice Maximum Strength Invisible Acne Cream;
(12) May's Drug Maximum Strength Invisible Acne Cream;

(13) ElectHealth Maximum Strength Invisible Acne Cream;

(14) CareOne Maximum Strength Invisible Acne Cream;

(15) Top Care Maximum Strength Invisible Acne Cream.
CODE
a) Lot 3C14A, Exp. 3/05; 3E01A, Exp. 5/05; 3H14A, 8/05; 3H26C, Exp. 8/05; 3J06B, Exp. 10/05;
b) Lot 3B20B, Exp. 2/05; 3C17A, Exp. 3/05, 3D24B, Exp. 4/05; 3E22B, Exp. 5/05; 3F05C, Exp. 6/05; 3G15A, Exp. 7/05; 3G18A, Exp. 7/05; 3G30B, Exp. 7/05; 3H13B, Exp. 8/05; 3H28C, Exp. 8/05; 3J01B, Exp. 10/05; 3J06A, Exp. 10/05; 4F08A, Exp. 6/06; 4F10A, Exp. 6/06; 4G15B, Exp. 7/06; 4G16A, Exp. 7/06; 4J01A, Exp. 10/06; 4J14B, Exp. 10/06; 4K17B, Exp. 11/06.
RECALLING FIRM/MANUFACTURER Qualis, Inc., Des Moines, IA
REASON cGMP Deviations: The active ingredient was for industrial use and not manufactured according to GMP's.
VOLUME OF PRODUCT IN COMMERCE

a) 13,080 tubes;
b) 98,856 tubes.
DISTRIBUTION Nationwide.

Dade Behring has Voluntarily Issued Nationwide Recall Of Microscan® Rapid Pos Inoculum Broth

Dade Behring, the world's largest company solely dedicated to clinical diagnostics, on January 26, 2005, initiated a product recall of six lots of B1015-14 MicroScan® Rapid Pos inoculum broth to prevent health risk to patients due to potential false antibiotic susceptibility results. The possibility of inaccurate susceptibility results for a pathogen could lead a physician to prescribe incorrect or suboptimal therapy. In rare instances this could result in severe or life-threatening consequences. By taking immediate action and notifying the 68 laboratories that received the recalled product, Dade Behring mitigated the risk to patients and to date no injuries have been reported as a result of this problem. Each laboratory was notified both by an overnight letter and either received a personal visit or a telephone call from Dade Behring to clarify actions to be taken by the laboratory regarding the product recall.

"Dade Behring's number one focus is on our customers, and we are deeply committed to providing quality products and resolving any customer concerns immediately," said Dave Edelstein, Chief Regulatory Officer. "The root cause has been identified to be a variation of the raw material in the broth manufactured for Dade Behring by a third party -- that can impact QC and clinical isolate performance. We have confirmed that each of our customers affected has been provided replacement product and should have no further concerns related to this recall. Additionally, Dade Behring is working on actions to prevent recurrence and has implemented increased quality control testing of this product to increase assurance of acceptability."

Dade Behring recommended that laboratories use an alternative method for susceptibility testing of Gram positive bacterial isolates (e.g., MicroScan® Dried overnight Gram Positive panels), and review the susceptibility results obtained with the affected broth lots to determine if additional corrective actions should be taken in the affected institutions. Laboratories were instructed to contact physicians when appropriate. Customers with questions may contact the Dade Behring MicroScan technical assistance center at 1-800-677-7226.

WEEK ENDING APRIL 9

PRODUCT
a) Intron A Powder for Injection, (Interferon alfa-2b, recombinant), 10 million IU per vial, For Intramuscular/Subcutaneous/Intralesional Use, Rx only, Refrigerate, NDC 0085-0571-02.
b) Intron A Powder for Injection, (Interferon alfa-2b, recombinant) 18 million IU per vial, For Intramuscular/Subcutaneous/Intravenous Use, Not for Intralesional Use, Rx only, Refrigerate, NDC 0085-
c) Intron A Powder for Injection, (Interferon alfa-2b, recombinant) 50 million IU, For Intramuscular/Subcutaneous/Intravenous Use,
Not for Intralesional Use, Rx only, Refrigerate, NDC 0085-0539-01.
CODE
a) Lot Numbers, exp.: 10 MIU-- 4-CO-200, June, 2006;
b) 18 MIU--4-CO-303, January, 2006; 18 MIU--4-CO-304, January, 2006; 18 MIU--4-CO-305, June, 2006.
c) 50 MIU--4-CO-400, June, 2006; 50 MIU--4-CO-401, June, 2006; 50 MIU--4-CO-402, June, 2006; 50 MIU--4-CO-403, June, 2006.
RECALLING FIRM/MANUFACTURER Schering Corporation, Kenilworth, NJ
REASON Label on powder vial incorrectly states Use reconstituted solution within one month. Label should correctly state Use reconstituted solution within 24 hours.
VOLUME OF PRODUCT IN COMMERCE 90,545 vials.
DISTRIBUTION Nationwide.

PRODUCT Antacid, Mint Flavor, Regular Strength, 150 count bottles packaged under the Bartell Drugs label, Distributed by: The Bartell Drug Company, Seattle, WA.
CODE Lot #330660, Exp. 11/06.
RECALLING FIRM/MANUFACTURER Magno Humphries, Inc., Tigard, OR
REASON Presence of foreign material: Bottles contain white powder, broken tablets and dark foreign material.
VOLUME OF PRODUCT IN COMMERCE 24 bottles.
DISTRIBUTION WA.

PRODUCT Faslodex (fulvestrant) Injection. Each carton contains 2 pre-filled syringes, 125 mg/2.5 ml(50 mg/ml), Rx only,
CODE
Lot number BX373 Exp 6/30/06,
Lot number CC148 Exp 6/30/06, and
Lot number BX829 Exp 6/30/06.
RECALLING FIRM/MANUFACTURER Astra Zeneca, Wilmington, DE
REASON Defective syringe delivery system.
VOLUME OF PRODUCT IN COMMERCE 7,716 units.
DISTRIBUTION Nationwide.

PRODUCT Sulfazineô EC 500 mg, Sulfasalazine Delayed Release Tablets, USP 500 mg, Rx only, 300 Tablets, NDC 0603-5803-25. CODE Lot #C0900703A (100 counts), C0900703B (300 counts).
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, NC
REASON Dissolution Failure: Out of Specification Results for Dissolution at 6 month room temperature stability.
VOLUME OF PRODUCT IN COMMERCE 7,123 bottles.
DISTRIBUTION Nationwide.

PRODUCT
a) Antacids, chewable, assorted flavors in plastic bottles distributed under 5 brands: BI-MART brand 150 tablet and 500 tablet bottles Distributed by: BI-MART; MEDICAP PHARMACY brand 150 tablets, Distributed by: Medicap Pharmacies, Inc. BARTELL DRUGS brand 150 tablets Distributed by: The Bartell Drug Company; Pharmacist's Choice brand 175 tablets DISTRIBUTED BY: PHARMACIST'S CHOICE; Superior brand 150 tablets Distributed by: WinCo Foods, Inc.
b) Acetaminophen/non-aspirin pain reliever, 325 mg, 100 tablet plastic bottles distributed under 5 brands: Kinney brand Distributed by: Kinney Drugs, Inc.; BI-MART brand Distributed by: BI-MART; HEALTH CARE AMERICA brand Distributed by: AFW Alliance;
MEDICAP PHARMACY brand Distributed by: Medicap Pharmacies, Inc.; Superior brand Distributed by: WinCo Foods, Inc.
c) Aspirin, 81 mg tablets, in plastic bottles, distributed under 7 brands: BARTELL DRUGS brand 250 tablet and 350 tablet bottles Distributed by: The Bartell Drug Company; MHL brand, 100 tablet bottles and 250 tablet bottles, Manufactured & Distributed by: Magno-Humphries Labs; Superior brand 100 tablet bottles Distributed by: WinCo Foods, Inc; Pharmacist's Choice, 150 tablet
bottles, Distributed by Pharmacist's Choice; MEDICAP PHARMACY brand, 100 tablet and 250 tablet bottles Distributed by: Medicap Pharmacies, Inc; BI-MART brand 100 tablet and 250 tablet bottles Distributed by: BI-MART; HealthPrin 500 coated aspirin tablets Distributed by: SMART PHARMACEUTICALS.
d) Extra strength non-aspirin pain reliever/sleep aid, acetaminophen 500mg & diphenhydramine hydrochloride 25mg, in plastic bottles,
distributed under 5 brands: BI-MART brand 100 tablet and 250 tablet bottles Distributed by: BI-MART; MEDICAP PHARMACY brand, 50 tablet bottles Distributed by: Medicap Pharmacies, Inc.; Superior brand, 50 tablets, Distributed by: WinCo Foods, Inc.; MHL brand 100 tablets Manufactured & Distributed by: Magno-Humphries Labs; BARTELL DRUGS brand 100 tablets, Distributed by: The Bartell Drug Company.
e) Children's non-aspirin pain reliever, acetaminophen 80 mg, fruit flavored tablets, 30 tablet plastic bottles, distributed under two brands: Suprior brand distributed by: WinCo Foods, Inc; BI-MART brand Distributed by: BI-MART.
f) Diphenhydramine hydrochloride 25 mg labeled as an allergy medication or sleep aid. Allergy labeling - BI-MART brand COMPLETE ALLERGY MEDICINE 100 tablet bottle Distributed by: BI-MART; Hi-SCHOOL pharmacy brand ALER-TABS 100 tablet bottles Distributed by: Hi-School Pharmacy, Inc.; Sleep aid labeling ‚ Pharmacist's Choice brand SLEEP-TABS 100 tablet bottle Distributed by Pharmacist's Choice; MHL Sleep-Tabs 36 tablet and 100 tablet bottle Manufactured & Distributed by: Magno-Humphries Labs; BI-MART brand SLEEP TABLETS 36 tablets Distributed by: BI-MART; Superior brand Sleep-Tabs 36 tablet bottle Distributed by:
WinCo Foods, Inc; BARTELL DRUGS brand Sleep- Tabs 36 tablet bottle Distributed by: The Bartell Drug Company.
CODE
a) Lot #s 329765, 329897, 329968, 329994, 330032, 330145, 330636; all with expiration 10/06;
b) Lot #s 329858, 330036, 330037, 330412, 330866; all with expiration 12/06;
c) Lot #s 328905, 329016, 329045, 329046, 328647, 327907, 329001, 328329, 329373, 329372, 329371, 329370, 329190, 329861, 330239, 330107, 330290, 330429, 330558, 330559, 330560, 330561, 330598, 330769, 330873, 330874, 331135, 331136; all with
expiration 10/06;
d) Lot #s 330116, 330484, 330672, 330772, 330512, 330871, 330870, 330941, 330936; all with expiration date 12/07;
e) Lot #s 330242, 330431, 330901, 331000; all with expiration date 10/07;
f) Lot # 328988; expiration 10/06. Lot #s 325624, 325651, 325774, 326039, 325875, 326273, 326296, 326247, 326504, 326559, 326480, 326592; expiration date 3/07.
RECALLING FIRM Magno Humphries, Inc., Tigard, OR
REASON Potential for products to be contaminated with metal particles.
VOLUME OF PRODUCT IN COMMERCE 38,824 bottles.
DISTRIBUTION Nationwide.

PRODUCT
a) Paxil CR Tablets (paroxetine HCl) 12.5 mg Controlled-Released Tablets, 30 count bottles and 7 count sample packs, Rx only, GlaxoSmithKline, Research Triangle Park, NC **** NDC 0029-3206-13.
b) Paxil CR Tablets (paroxetine hydrochloride) 25 mg Controlled-Release Tablets, 30 count bottles and 7 count sample packs, Rx only,
NDC 0029-3207-13.
c) Paxil CR (paroxetine hydrochloride) 37.5 mg Controlled-Release Tablets, 30 count bottles, Rx only, NDC 0029-3208-29.
d) Avandametô Tablets (rosiglitazone maleate/ metformin HCl), 1mg/500mg, 60 and 100 count bottles, Rx only, 60's tablets -NDC-0007-3166-18 and 100 tablets -NDC-0007-3166-20.
CODE
a), b), c) All Codes;
d) Lot/Exp. 1284A66/Jun-06; 1344A66/Sep-06; 1354A66/Sep-06; 1364A66/Sep-06; F1394A66/Sep-06; 1294A66/Jun-06;
1304A66/Jun-06; 1314A66/Jun-06.
RECALLING FIRM/MANUFACTURER Glaxosmithkline, Cidra, PR
REASON Low-level manufacturing defect that may result in the tablets splitting apart and patients not receiving the proper amount of medication;
VOLUME OF PRODUCT IN COMMERCE
a) 5,690,165 bottles, 30's count;
b) 11,803,780 bottles, 30's counts;
c) 2,103,976 bottles, 30's count;
d) 71,048 bottles, 60's count; 43,309 bottles, 100's count.
DISTRIBUTION Nationwide.

PRODUCT Aplicare Povidone-Iodine USP 7.5%, 4 Fl. Oz. (118 mL) bottle, OTC.
CODE Lot Numbers: 92763 Exp 12/06 92767 Exp 01/07 92768 Exp 01/07 93725 Exp 02/07 93730 Exp 02/07
RECALLING FIRM Aplicare, Inc., Branford, CT
REASON Mislabeled: The front panel incorrectly states Povidone Iodine Concentration as 7.5% instead of the actual concentration of 10.0%.
VOLUME OF PRODUCT IN COMMERCE 3,938 cases.
DISTRIBUTION Nationwide.

PRODUCT Synthroid (levothyroxine sodium tablets, USP) 50 mcg, Rx only, Hospital Unit Dose Blister Packaging 10 tablets per Blister Card, 100 tablets per Carton.
CODE Lot Numbers: 0000347787 - Expiration Mar 1, 2005 and 0000349661 - Expiration Aug 1, 2005.
RECALLING FIRM/MANUFACTURER Abbott Laboratories MPG, Abbott Park, IL
REASON Lack of assurance of meeting stability potency through expiry.
VOLUME OF PRODUCT IN COMMERCE 4,191 units.
DISTRIBUTION Nationwide.

PRODUCT
a) Metronidazole Capsules, 375mg, Rx only, NDC 53265-353-05 (50 count).
b) Metronidazole Tablets, 250mg, Rx only, NDC 53265-374-10 (100 count); NDC 53265-374-50 (500 count); NDC 53265-374-70 (250 count).
c) Metronidazole Tablets USP, 500mg, Rx only, NDC 53265-375-10 (100 count); NDC 53265-375-50
(500 count); 53265-375-60 (60 count).
d) Metronidazole Extended-Release Tablets, 750mg, Rx only, NDC 53265-352-03 (30 count).
CODE
a) Lot Number, Exp. Date: 307256B, 07/05; 307257B, 07/05; 411107B, 11/06;
b) Lot Number, Exp. Date: 307078B, 06/05; 307080B, 06/05; 312124A, 02/06; 402077A, 03/06; 408155B, 09/06; 411036A, 10/06; 307079F, 06/05; 307080F, 06/05; 312122B, 01/06; 312123A, 01/06; 312124B, 02/06; 402078A, 03/06; 402077C, 03/06;
408155D, 09/06; 411035A, 10/06; 411036C, 10/06; 312122A, 01/06; 402077B, 03/06; 408155C, 09/06;
c) Lot Number, Exp. Date: 308158C, 08/05; 401162A, 02/06; 401163A, 02/06; 409101A, 09/06; 410108B, 10/06; 401161D, 01/06; 401163B, 02/06; 401162B, 02/06; 402080B, 03/06; 402081A, 08/06; 409100A, 09/06; 409102B, 09/06; 410107A, 10/06;
410108C, 10/06; 401161B; 01/06; 402080A, 03/06; 409102A, 09/06;
d) Lot Number, Exp Date: 310104A, 09/05; 310105A, 09/05; 310106A, 10/05; 402079A, 03/06; 405002A, 05/06; 405001A, 05/06.
RECALLING FIRM/MANUFACTURER Able Laboratories Inc., South Plainfield, NJ
REASON Mislabeled due to non compliance with 21CFR201.24.
VOLUME OF PRODUCT IN COMMERCE 75,468 bottles.
DISTRIBUTION Nationwide.

WEEK ENDING APRIL 16

PRODUCT Male Power Plus, maximum strength male sexual stimulant oral tablets, OTC, sold as a Dietary Supplement.
CODE All codes.
RECALLING FIRM Spectrum Distribution & Marketing, Inc., Beverly Hills, CA
REASON Product contains undeclared Taladafil.
VOLUME OF PRODUCT IN COMMERCE 105,000 tablets.
DISTRIBUTION Nationwide.

PRODUCT
a) METHYLIN Chewable Tablets, (Methylphenidate HCl), 2.5 mg, Rx only, 100 count bottles, **** NDC 68188-132-01.
b) METHYLIN Chewable Tablets, (Methylphenidate HCl), 5 mg, Rx only, 100 count bottles, **** NDC 68188-135-01.
c) METHYLIN Chewable Tablets, (Methylphenidate HCl), 10 mg, Rx only, 100 count bottles, **** NDC 68188-137-01.
CODE
a) AMT20401A, AMT20402A, AMT20403A, AMT20404A;
b) AMT50401A, AMT50402A, AMT50403A, AMT50404A;
c) AMT100401A, AMT100402A, AMT100403A, AMT100404A;
RECALLING FIRM Alliant Pharmaceuticals, Alpharetta, GA
Manufacturer: Mallinckrodt Inc., St. Louis, MO.
REASON Superpotent.
VOLUME OF PRODUCT IN COMMERCE 10,340/100-tablet bottles.
DISTRIBUTION Nationwide.

PRODUCT
a) Promethazine Hydrochloride Suppositories, USP, 12.5mg.
b) Promethazine Hydrochloride Suppositories, USP, 25mg, NDC 53265-762-12.
CODE
a) Lot, Exp. Date: 312016A, 11/05; 403120A, 02/06; 403207A, 03/06; 403208A, 03/06; 406094A, 05/06;
b) Lot, Exp. Date: 304085A, 04/05; 403053A, 02/06; 403054A, 02/06; 404080A, 02/06.
RECALLING FIRM/MANUFACTURER Able Laboratories, Inc., S Plainfield, NJ
REASON Stability Failure.
VOLUME OF PRODUCT IN COMMERCE 1,916,213 units of 12.5 mg; 185,540 units of 25 mg.
DISTRIBUTION Nationwide.

PRODUCT Oxygen compressed, USP, in steel and aluminum cylinders, size M6, ML6, C (also referred to as M9), D, and E.
CODE Cylinder serial numbers: D00143, D115847, D179383, D263955, D281785, D293051, D355188, D40255, D40261, D40264, D40266, D40674, D40675, D413746, D414051, D414888, D415864, D416763, D419058, D420116, D420123, 130446, 218144, 324205, 376585, 619682, 662196, 744281, 907781, 1102402, 1102416, 1975A, 265441F, 26782E, 268683D, 640396D, 718890E, 901501D, 90741F, 933279D, A139650, A472676, A50412433, A6888, A86469, A86485, A86491, A86503, A86524, A86530, A86579, A86581, A86591, A86620, A98240, A99080, AS0298919, AS0298923, S0298937, AS0298947, AS0298958, AS0298959, AS0298966, S0298973, AS0298975, AS0301087, AS0301089, AS0302288, AS0318835, AS0318858, AS0318862, AS0318866, AS0318883, AS0318887, AS0318908, AS0318914, AS0319815, AS0321425, AS0321429, AS0321443, AS0322017, AS0322030, AS0322033, AS0322055, AS0322058, AS0322059, AS0322076, AS0322087, AS0322088, AS0322090, AS0322298, AS0323860, AS0323877, AS0323897, AS0323899, AS0323903, AS0326742, AS0326781, AS0327877, AS0364885, AS0383387, AS0383999, AS0388066, AS0388121, AS0390421, AS0392872, AS0392947, AS0392949, AS0392976, AS0393947, AS0393948, AS0393954, AS0394005, S0394197, AS0394209, AS0394885, AS0394895, AS0398014, AS0398254, AS0399089, AS0399114, AS0399115, AS0399135, AS0399199, AS0412040, AS0412045, AS0412060, AS0412090, AS0412112, AS0412433, AS0416076, AS0417524, AS0417554, AS0417574, AS0418090, AS0420424, AS0420458, AS0420470, AS0420474, AS0420476, AS0420481, AS0422330, AS0422471, AS0422492, AS0422495, AS0422501, AS0422508, AS0422524, AS0425336, AS0425385, AS0425395, AS0425402, AS0425409, AS0425426, AS0425457, AS0425478, AS0427331, AS0427349, AS0427351, AS0427354, AS0427363, AS0427368, AS0427383, AS0427384, AS0427388, AS0427392, AS0427398, AS0427402, AS0427404, AS0427420, AS0427454, AS0599121, AS0932347, AS095023, AS095025, AS095050, AS095070, AS298923, AS322087, B008312, B215219, B28089, B28154, B40489, BX133121, BX133296, BX133299, BX133887, BX133900, BX133908, BX134955, BX135096, BX135607, BX138895, BX13928, BX13946, BX13966, BX349248, BX349251, BX349252, BX349254, BX349260, BX349261, BX349262, BX349263, BX349265, BX349265, BX349279, BX349280, BX349282, BX349284, BX349289, BX349298, BX349300, BX349315, BX349318, BX349322, BX349333, BX349334, BX349335, BX349337, BX349339, BX349340, BX349366, BX349369, BX349939, BX350634, BX35985, BX36394, BX36679, BX36751, BX376638, BX385598, BX385601, BX385609, BX385610, BX385611, BX385614, BX385779, BX386306, BX386318, BX386320, BX386321, BX386330, BX386344, BX386349, BX386362, BX386389, BX386396, BX386404, BX424412, BX430119, BX430136, BX430148, BX430154, BX430163, BX562606, BX6752, BX7350, BX7354, BX74515, BX74530, BX74596, BX848752, C66325, C68417, CA84238, E110762, E112141, E112163, E117868, E122619, E122680, E122738, E128092, E139583, E139588, E180676, E195147, E195347, E196503, E196504, E196508, E196512, E196525, E199822, E199963, E200499, E200502, E200508, E200513, E200519, E200526, E200591, E200693, E200702, E200716, E200725, E200728, E200732, E200733, E200746, E200748, E200749, E201166, E205114, E205128, E205176, E205254, E205262, E205273, E205278, E205279, E205339, E205369, E205371, E205374, E205384, E205386, E205388, E205401, E205402, E205406, E205425, E205762, E214095, E215219, E220749, E223581, E22889, E229009, E230347, E233994, E235161, E244807, E244880, E244887, E245668, E258528, E266490, E270987, E271823, E271829, E271831, E271850, E271979, E272256, E280369, E284083, E288657, E290369, E29905, E30179, E30278, E304264, E324370, E327920, E335514, E336947, E338632, E341101, E34746, E363570, E367552, E371670, E377019, E377446, E377814, E377816, E377819, E377820, E377825, E377827, E377830, E377837, E377841, E377846, E377851, E377852, E377853, E377856, E377862, E377876, E377877, E377881, E377883, E377887, E377891, E377994, E378042, E378046, E378804, E38087, E383859, E384411, E384428, E384440, E384441, E384445, E384451, E384459, E384460, E384473, E384477, E384483, E384493, E384499, E384500, E384508, E384509, E384511, E384513, E384682, E384709, E384719, E385475, E385714, E385726, E385737, E385746, E385755, E390324, E40359, E433631, E439768, E440417, E440418, E440419, E440420, E440425, E440427, E440645, E441089, E441092, E441095, E441098, E441099, E441100, E441101, E441104, E441106, E441107, E441110, E441111, E441112, E441116, E441121, E441125, E441130, E441134, E441136, E441140, E441141, E441142, E441145, E441147, E441152, E441157, E441159, E441163, E441164, E441166, E441169, E441173, E441701, E441711, E441723, E462085, E505563, E505581, E505592, E505604, E505609, E505627, E505662, E505671, E505751, E505759, E505760, E505766, E506147, E511777, E54439, E55225, E552451, E566313, E566315, E567568, E567839, E575739, E575746, E575800, E575801, E575809, E575814, E575815, E575819, MM1102482, MM1102483, MM1102487, MM1102495, MM1102497, MM1102499, MM1102584, MM1102798, MM1102811, MM1102816, MM1102826, MM1102828, MM1102829, MM1102830, MM1102831, MM1102855, MM1102862, MM1102871, MM1102881, MM1102886, MM1102911, MM1102918, MM1102919, MM1102922, MM1102950, MM1102952, MM1102953, MM1102960, MM1102961, MM1102971, MM1102977, MM1102982, MM1102983, MM1102984, MM1102987, MM1102989, MM1103099, MM1103108, MM1103110, MM1103143, MM1103147, MM1103153, MM1103159, MM1103164, MM1103166, MM1103167, MM1103174, MM1103187, MM1103527, MM1103530, MM1103546, MM1103548, MM1168262, MM1168356, MM1168529, MM1177478, MM1177481, MM1178006, MM1180442, MM1180448, MM1180449, MM1180456, MM1180457, MM1180461, MM1180491, MM1180658, MM1180699, MM1180713, MM1180724, MM1180725, MM1180728, MM1180740, MM1180741, MM1180936, MM1180937, MM1180938, MM1180941, MM1180944, MM1180945, MM1180946, MM1180946, MM1180947, MM1180949, MM1180951, MM1180954, MM1180957, MM1180959, MM1180960, MM1180961, MM1180966, MM1180969, MM1180974, MM1180975, MM1180976, MM1180979, MM1180986, MM1180987, MM1180989, MM1180994, MM1180996, AP0071959, AP0071968, AP0071977, AP0071982, AP0071991, AP0072002, AP0074875, AP010142, AP010147, AP010151, AP010158, AP010158, AP010160, AP010164, AP010165, AP010166, AP010167, AP010172, AP010180, AP010196, AP010202, AP010206, AP010212, AP011272, AP011343, AP011350, AP011352, AP011361, AP011371, AP011373, AP011379, AP011389, AP011407, AP011409, AP011525, AP011526, AP011532, AP011543, AP011562, AP011799, AP019242, AP019293, AP019294, AP019295, AP019296, AP020904, AP020907, AP020919, AP020920, AP020925, AP021031, AP021049, AP021068, AP021070, AP021080, AP021081, AP023399, AP064152, AP152953, BV12083, BV12945, BV23595, BV29092, BV29094, BV29096, BV29098, BV29101, BV29102, BV29103, BV29105, BV29109, BV29135, BV29142, BV32040, BV32947, BV35960, BV35979, BV35983, BV35985, BV35992, BV36000, BV36001, BV36003, BV36004, BV36007, BV36011, BV36013, BV36016, BV36023, BV36024, BV36040, BV36042, BV36599, BV36601, BV36626, BV36627, BV36679, BV36688, BV36705, BV36707, BV66587, BV66592, BV66604, BV66627, BV66631, BV66632, BV66637, BV66641, BV66659, BV66670, BV66674, BV66677, BV66687, BV66708, BV66711, BV66713, BV67745, BV68057, BV69433, BV70843, BV71055, BV71149, BV71342, BV71454, BV71588, BV71895, BV72154, BV72155, BV72406, BV72442, BV72814, BV7333, BV7342, BV7352, BV7354, BV7367, BV73721, BV73847, BV73966, BV74139, BV74433, BV74513, BV74515, BV74516, BV74518, BV74521, BV74522, BV74530, BV74533, BV74534, F34656, F34666, F34680, F34690, F34722, F34723, F34733, F34737, F34742, F34749, F34751, F34890, F37213, F37218, F37856, F39206, F39585, F39775, F39793, F39813, F40118, F40359, F40383, F41076, F41403, F42764, F43178, F43216, F43292, F43314, F43333, F44121, F44475, F46316, F46403, F46467, F48055, F50590, F51200, F53318, F53321, F53322, F53325, F53327, F53331, F53333, F53334, F53339, F53340, F53359, LL0278699, LL0278716, LL0278726, LL0278727, LL0278730, LL0278731, LL0278732, LL0278734, LL0278735, LL0278736, LL0278737, LL0278739, LL0278741, LL0278743, LL0278744, LL0278745, LL0278746, LL0278747, LL0278748, LL0278749, LL0278751, LL0278752, LL0278753, LL0278756, LL0278758, LL0278759, LL0278761, LL0278764, LL0278766, LL0278767, LL0278768, LL0278769, LL0278770, LL0278771, LL0278775, LL0278777, LL0278781, LL0278782, LL0278784, LL0278785, LL0278786, LL0278787, LL0278790, LL0278795, LL0278806, LL0278808, LL0278809, LL0278810, LL0278811, LL0278822, LL0278823, LL0279653, LL0279789, LL0301965, LL0301966, LL0301978, LL0301982, LL0302003, LL0302077, LL0302975, LL0302975, LL0302976, LL0302977, LL0302978, LL0302979, LL0302980, LL0302984, LL0302985, LL0302986, LL0302988, LL0302991, LL0302992, LL0302993, LL0302994, LL0302995, LL0302997, LL0303002, LL0303003, LL0303004, LL0303005, LL0303006, LL0303009, LL030301, LL0303012, LL0303013, LL0303014, LL0303019, LL0303019, LL0303021, LL0303022, LL0303023, LL0303024, LL0303027, LL0303028, LL0303031, LL0303033, LL0303034, LL0303035, LL0303039, LL0303041, LL0303044, LL0303049, LL0303050, LL0303053, LL0303057, LL0303058, LL0303060, LL0303061, LL0303062, LL0303063, LL0303065, LL0303065, LL0303066, LL0303069, LL0303070, LL0303071, LL0304889, LL0305007, LL0305033, LL0362312, LL0370798, LL0370801, LL0370802, LL0370811, LL0370815, LL0370816, LL0370822, LL0370824, LL0372243, LL0372302, LL0372305, LL0372307, LL0372312, LL0372314, LL0372320, LL0372321, LL0372323, LL0372337, LL0372347, LL0372384, LL0372385, LL0375095, LL0375096, LL0375102, LL0375107, LL0375111, LL0375112, LL0375115, LL0375118, LL0375129, LL0375130, LL0375131, LL0375136, LL0375137, LL0375140, LL0375142, LL0375144, LL0375147, LL0375151, LL0375152, LL0375161, LL0375164, LL0375172, LL0375175, LL0375178, LL0375180, LL0375325, LL0375326, LL0375331, LL0375337, LL0375340, LL0375363, LL061856, LL061857, LL061858, LL061862, LL061865, LL061871, LL061873, LL061878, LL061882, LL061886, LL061888, LL061889, LL061890, LL061891, LL061894, LL061895, LL061897, LL061898, LL061900, LL061902, LL061907, LL061909, LL061910, LL061911, LL061913, LL061915, LL061917, LL061921.
RECALLING FIRM Keelers Medical Supply Inc, Yakima, WA
REASON GMP deviations including, but not limited to, failure to test product for purity and identity.
VOLUME OF PRODUCT IN COMMERCE 998 cylinders
DISTRIBUTION WA.

WEEK ENDING APRIL 23

PRODUCT
SKY, Acetaminophen, NDC 63739-002-01, 325 mg tablets, Pain Reliever/Fever Reducer, UD 750 Tablets (25X30), For Institutional Use Only.

a) Unit Dose: 1500 tablets (25 sheets per box x 30 individual doses per sheet x 2 tablets per blister pack), NDC 6373900211*

b) UD 750 (25 sheets per box x 30 individual doses per sheet), NDC 6373900201*

c) Punch Card 1500 (25 sheets per box x 30 individual doses per sheet x 2 tablets per blister pack), NDC 6373900213.
CODE
a) Lot #0017359;
b) Lot #0017358;
c) Lot #0017359.
RECALLING FIRM/MANUFACTURER
Recalling Firm: McKesson Packaging Services, Concord, NC
Manufacturer: MAGNO-HUMPHRIES, Laboratories, Incorporated, Tigard, OR.
REASON The product may contain metal particles.
VOLUME OF PRODUCT IN COMMERCE 4,755 boxes.
DISTRIBUTION Nationwide.

PRODUCT Propoxyphene Napsylate and Acetaminophen Tablets USP, 100 mg/650 mg, PINK, CIV, 1000 tablet bottles, Rx only, Firm on label: Mallinckrodt Inc., St. Louis, Missouri ** Tyco Healthcare, NDC 0406-1772-10.
CODE 1721J02641, Exp. 12/2006.
RECALLING FIRM Mallinckrodt, Inc., Berkeley, MO
REASON Labeling: Bottle label identifies pink tablets but bottle actually contains white tablets.
VOLUME OF PRODUCT IN COMMERCE 1,194 bottles x 1000 tablets.
DISTRIBUTION Nationwide.

PRODUCT
a) Premarin (conjugated estrogens tablets USP), 0.625 mg, 1,000 tablet bottles, Rx, NDC 0046-0867-91. Firm on label: Wyeth Pharmaceuticals Inc., Philadelphia, PA.
b) Premarin (conjugated estrogens tablets USP), 0.3 mg, 1,000 tablet bottles, Rx, NDC 0046-0868-91.
CODE
a) A45580, Exp. 10/2005;
b) A32677, Exp. 07/2005.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richmond Division of Wyeth, Richmond, VA
REASON Dissolution failures.
VOLUME OF PRODUCT IN COMMERCE
a) 0.625 mg – 16,737 bottles;
b) 0.3 mg – 11,990 bottles.
DISTRIBUTION Nationwide.

WEEK ENDING APRIL 30

PRODUCT
a) Pramosone Cream 1% (hydrocortisone acetate 1% and pramoxine HCl 1%) Net Wt. in 1 oz (28.4 g) tubes, Rx only, NDC 0496-0716-04.

b) Pramosone Cream 2.5% (hydrocortisone acetate 2.5% and pramoxine HCl 1%) Net Wt. 1 oz (28.4 g) and 2 oz (57 g) tubes, Rx only, NDC 0496-0717-03 and 0496-0717-04.

c) Analpram HC Cream 1% (hydrocortisone acetate 1% and pramoxine HCl 1%) Net Wt. 1 oz tubes, Rx only, NDC 0496-0778-04.

d) Analpram HC Cream 2.5% (hydrocortisone acetate 2.5% and pramoxine HCl 1%) Net Wt. 1 oz tubes, Rx only, NDC 0496-0800-04. CODE
a) Lots 03068A, exp. 03/05 and 04026A, exp. 02/06;
b) Lots 03071A, exp. 04/05; 03152A, exp. 08/05; lot 03169A, exp. 08/05 and 04024A, exp. 01/06;
c) Lot 03202, exp. 10/05;
d) Lots 03228A, exp. 10/05; 03232A, exp. 10/05; 03233A, exp. 1/0/05; 03234A, exp. 10/05; 03236A, exp. 10/05; 04001A, exp. 01/06 and 04002A, exp. 01/06.

RECALLING FIRM Ferndale Laboratories, Inc., Ferndale, MI
REASON Superpotent; pinhole defects in tubes may cause product to dry out and become more concentrated.
VOLUME OF PRODUCT IN COMMERCE 180,461 tubes.
DISTRIBUTION Nationwide.

Amerisource Health Services Recalls One Lot of Famotadine Injection

Amerisource Health Services, DBA American Health Packaging, Columbus, OH announced that it is voluntarily recalling one lot of Famotidine Injection, 20 mg/2 mL (NDC 55390-029-10), Lot# 045715, 180 boxes, exp. 04/06, due to a lack of sterility assurance reported by the original manufacturer’s recall letter of April 19, 2005. American Health Packaging performed secondary packaging on this product which consisted of placing the manufacturer’s sealed vial in a plastic bag.

This prescription product was distributed in October and November, 2004 to AmerisourceBergen, Suwanee, GA, who further distributed the product only to Piedmont Hospital, Atlanta, GA. Customers that have any vials of this lot of Famotidine Injection should discontinue distribution and use of the lot immediately and contact American Health Packaging, Customer Service Department (1-800-707-4621) for a returned goods authorization.

Famotidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication. Non sterility of injectable products can represent a serious hazard to health that can lead to life threatening injuries and death.

Consumers and health care professionals with questions may contact Robert L. Kavanaugh, VP Regulatory and Quality Assurance, Amerisource Health Services, at 1-800-707-4621 between the hours of 8:00 am and 4:00 pm, Monday through Friday.