WEEK ENDING DECEMBER 3

PRODUCT Invigorate(tm) Liquid Drink in 32 fluid ounce plastic bottles. Product label declares as an ingredient "2 (3H) "2(3H) Furanone Di-hydro", which is also known as gammabutyrolactone (GBL). The supplement which stimulates the body’s own production of human growth hormone and as a sleep aid which "will induce deep invigorating sleep that will last 3-4 hours.
CODE All lot codes remaining on the market.
MANUFACTURER Invigorate International, New York, New York.
RECALLED BY Cabot Industries, LLC, West Babylon, New York
DISTRIBUTION New York, New Jersey, Massachusetts, Pennsylvania, Maryland, Virginia, Ohio, South Carolina, Florida, Alabama, Mississippi, Michigan, Illinois, Kansas, Colorado.
QUANTITY Undetermined.
REASON Product is an unapproved new drug.

PRODUCT Various Rx products:
1. Dobutamine Injection, USP, 250 mg, 20 mL Single Dose Vial
2. Etopside Injection, USP, 100 mg, 5 mL Multiple Dose Vial
3. Etopside Injection, USP, 150 mg, 7.5 mL Multiple Dose Vial
4. Etopside Injection, USP, 500 mg, 25 mL Multiple Dose Vial
5. Etopside Injection, USP, 1 g, 50 mL Multiple Dose Vial
6. Fentanyl Citrate Injection, USP, 1000 mcg, 20 mL Single Dose Vial
7. Fentanyl Citrate Injection, USP, 2500 mcg, 50 mL Single Dose Vial
8. Heparin Sodium Injection, USP, 1000 USP units/mL, 5 mL Ampul
9. Lorazepam Injection, USP, 1 mg/0.5mL syringe
10. Lorazepam Injection, USP, 4 mg/mL , 1 mL syringe
11. Lorazepam Injection, USP, 2 mg/mL , 1 mL and 10 mL Multiple Dose Vials
12. Lorazepam Injection, USP, 4 mg/mL , 1 mL and 10 mL Multiple Dose Vials
13. Morphine Sulfate Injection, USP, 15 mg/mL, 20 mL Multiple Dose Vial
14. Morphine Sulfate Injection, USP, 100mg/4mL, 4 mL Single Use Vial
15. Morphine Sulfate Injection, USP, 250/10mL, 10 mL Single Use Vial
16. Morphine Sulfate Injection, USP, 500 mg/20mL, 20 mL Single Use Vial
17. Morphine Sulfate Injection, USP, 1g/40mL, 40 mL Single Use Vial
18. Morphine Sulfate Injection, USP, NO BACTERIOSTAT ADDED, 500 mg/10mL, 10 mL Single Use Vial
19. Morphine Sulfate Injection, USP, NO BACTERIOSTAT ADDED, 1g/20mL, 20 mL Single Use Vial
20. Morphine Sulfate Injection, USP, NO BACTERIOSTAT ADDED, 2g/40mL, 40 mL Single Use Vial
21. Morphine Sulfate Injection, USP, PRESERVATIVE FREE, 100mg/4mL, 4 mL Single Use Vial
22. Morphine Sulfate Injection, USP, PRESERVATIVE FREE, 250mg/10mL, 10 mL Single Use Vial
23. Morphine Sulfate Injection, USP, PRESERVATIVE FREE, 500mg/20mL, 10 and 20 mL Single Use Vial
24. Morphine Sulfate Injection, USP, PRESERVATIVE FREE, 1g/40mL, 40 mL Single Use Vial
25. Neostigmine Methylsulfate Injection, USP, 0.5mg/mL, 10 mL Multiple Dose Vial
26. Neostigmine Methylsulfate Injection, USP, 1mg/mL, 10 mL Multiple Dose Vial
27. Tobramycin Sulfate Injection, USP, 20 mg, 2 mL vial
28. Tobramycin Sulfate Injection, USP, 80 mg, 2 mL vial
29. Tobramycin Sulfate Injection, USP, 40 mg/mL, 30 mL Multiple Dose Vial.
CODE All lot codes.
MANUFACTURER Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
DISTRIBUTION Nationwide and Canada.
QUANTITY Undetermined.
REASON Insufficient equipment cleaning (equipment residues detected talc and aliphatic hydrocarbon).

PRODUCT CTDexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, in 30 ml vial, an adrenocortical steriodal anti-inflammatory drug, intended for administration by intravenous, intramuscular, intra-articular, intra-lesional, and soft tissue routes, under the following labels: NDC 0402,-0807-30 (Steris Laboratories, Inc.); NDC 0364-6681-56 (Schein Pharmaceutical, Inc.); NDC 0182-3007-66 (Zenith Goldline) NDC 12671-807-30 (Ace Surgical Supply).
CODE Lot Numbers: 98B790 EXP 9/99, 98E010 EXP 9/99, and 98E020 EXP 10/99.
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.
DISTRIBUTION Nationwide.
QUANTITY 81,958 units were distributed.
REASON Insufficient test methods for product release to assure identity, strength, purity, and quality.

PRODUCT Rocaltrol Capsules, (Calcitriol), 0.25 mcg, Rx, in 100 capsule bottles. NDC #004-0143-01.
CODE Lot #0419 EXP 10/31/00.
MANUFACTURER Roche Laboratories, Inc., Nutley, New Jersey.
DISTRIBUTION Nationwide.
QUANTITY 173 bottles were distributed.
REASON Potential microbial contamination (Bacillus cereus/Methylobacterium sp).

PRODUCT Liquid Medical Oxygen USP, contained in cyrogenic units, Rx used for respiratory therapy.
CODE All lots transfilled between 1/11/99 and 4/19/99 and lot #05119961 transfilled on 5/11-12/99.
MANUFACTURER Home Care Supply Holdings, Bethpage, New York.
DISTRIBUTION New York.
QUANTITY 35 vessels were distributed; firm estimated that none remained in commerce.
REASON Current good manufacturing practice deviations including but not limited to failure to assay for identity and strength.

PRODUCT Gentamicin Sulfate, USP, bulk and in 50 kg fiber drums, Rx, for manufacturing use only.
CODE All lots with prefix SC-GM 96, SC-GM 97, SC-GM 98 and SCGM99.
MANUFACTURER Long March Pharmaceutical Plant, Leshan, Sichuan, Peoples Republic of China.
RECALLED BY Helm New York, Inc., Piscataway, New Jersey
DISTRIBUTION Missouri, New York, Illinois, California, New Jersey, Iowa, Iowa, Arizona, Ohio.
QUANTITY 26,953 kg. were distributed; firm estimated that 1,500 kg. remained on market at time of recall initiation.
REASON Current good manufacturing practice deviations (at manufacturing site in China).

PRODUCT Derma-Clear(tm), Skin Bleaching Treatment and Jeval A- Peel, Skin Bleaching Treatment, over-the-counter topical cream in 2 and 4 Oz. Plastic jars, (same ingredients, 2 trade names for distribution).
CODE
Lot Number Batch Number
90-0-5 3728
0-0-5 3728
1234567890-7 4314
234567890-7 5109
34567890-7 5245
4567890-7 5461
567890-7 6197
67890-7 6242
7890-7 7237.
MANUFACTURER Cosmetic Specialty Labs, Inc. (CSL), Lawton, Oklahoma.
DISTRIBUTION Texas.
QUANTITY 5,279 units were distributed.
REASON Product is a new drug without new drug approval (contains more than 2% hydroquinone).

PRODUCT Country Health Formula #63 MSM Eye and Ear Drops, OTC, in 1 ounce bottles, distributed by BioMechanics, Aberdeen, Idaho.
CODE Lot Numbers: 433, 7538, 9463 and 9749.
MANUFACTURER Cosmetic Specialty Labs, Inc., Lawton, Oklahoma.
DISTRIBUTION Idaho.
QUANTITY 541 containers were distributed.
REASON Current good manufacturing practice deviations.

PRODUCT Anzemet Tablets (Dolasetron Mesylate), 100 mg, bottles of 5 tablets, Rx anti-nauseant and anti-emetic. NDC #0088-1203-05.
CODE Lot Numbers: 3001616 EXP 2/01, 3003145 EXP 2/01, and 3003148 EXP 4/01.
MANUFACTURER Hoechst Marion Roussel, Inc., Cincinnati, Ohio.
DISTRIBUTION Ohio and Missouri.
QUANTITY 10,329 bottles were distributed.
REASON Stability (6 month) test failure elevated degradation product.

PRODUCT a) Estrone Injectable Suspension, USP, 5 mg/mL, in 10 ml multiple dose vials, Rx steriodal estrogen intended for intramuscular injection, under the following labels: NDC 0677-0274-21 (United Research Laboratories) NDC 57699-041-10 (A&G Pharmaceuticals)
b) Gentamicin Sulfate Injection, 40 mg/mL, 20 mL vial, Rx sterile aqueous solution for parenteral injection, under the following labels: NDC 0402-0559-20 (Steris Laboratories) NDC 0182-1424-65 (Goldline Laboratories) NDC 0536-4690-73 (Rugby Laboratories).
CODE Lot Numbers: a) 98B250 EXP 2/01; b) 98B760 EXP 2/01, and 98D940 4/01.
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.
DISTRIBUTION a) New Jersey, Indiana; b) Nationwide and Puerto Rico.
QUANTITY a) 30,033 vials; b) 35,234 vials were distributed.
REASON Current good manufacturing practice deviations: Lack of annual stability data.

PRODUCT Klonopin (brand of Clonazepam) Tablets, 0.5 mg, 1 mg, and 2 Mg, distributed in bottles of 100 tablets and cartons each:
a) Klonopin (Clonazepam) tablets, 0.5 mg, 25 and 100 tablet units:
b) Klonopin (Clonazepam) tablets, 1 mg, 25 and 100 tablet units;
c) Klonopin (Clonazepam) Tablets, 2 mg, 25 and 100 tablet units.
CODE All lots. NDC 0004-0068-01, 0004-0068-50, 0004-0058-01, 0004-0058-50, 0004-0098-01 AND 0004-0098-50.
MANUFACTURER Roche Pharma, Inc., Humacao, Puerto Rico.
RECALLED BY Roche Laboratories, Inc., Nutley, New Jersey
DISTRIBUTION Nationwide.
QUANTITY Approximately 48,706 pieces of all three strengths combined were distributed.
REASON Impurity level exceeds specification.

PRODUCT Duratuss G Tablets, (Guaifensin), 1200 mg, in 500 tablet bottles, Rx 12-hour sustained release expectorant.
CODE Lot Numbers: J980726A and J9800727A.
MANUFACTURER Mikart, Inc., Atlanta, Georgia.
DISTRIBUTION Wisconsin.
REASON Dissolution failure.

PRODUCT Koleprin DM Caplets, in 30 caplet bottles, OTC prompt release, cough and cold medication.NDC #0927-018-07.
CODE Lot #98603 EXP 2/01.
MANUFACTURER SSS/Pfeiffer Pharmaceuticals, Inc., Atlanta, Georgia.
DISTRIBUTION Nationwide.
QUANTITY 2,659 units were distributed; firm estimated that 2,540 units remained on market at time of recall initiation.
REASON Friability failure (at 3 month stability).

PRODUCT Streptomycin Sulfate, USP, bulk, in 5 kg fiber drums, Rx for manufacturing use only
CODE Lot Numbers: SC-SM980802, SC-SM 980701, SC-SM980203, SC-SM980204, SC-SM980205.
MANUFACTURER Long March Pharmaceutical Plant, Leshan, Sichuan, Peoples Republic of China.
RECALLED BY Helm New York, Inc., Piscataway, New Jersey
DISTRIBUTION New York, New Jersey, Ohio, Missouri, Arkansas, North Carolina, Iowa, California.
QUANTITY 780 kg. were distributed; firm estimated that 25 kg remained on market at time of recall initiation.
REASON Current good manufacturing practice deviations (at manufacturing site in China).

PRODUCT Aldoril D50 Tablets, (Methyldopa (500mg)-Hydro-chlorothiazide (50mg)), in 100 Tablet bottles, Rx used to control hypertension. NDC #0006-0935-68
CODE Lot Numbers: B5511 EXP 1/00, D5714 EXP 4/00, D5719 EXP 4/00, E6156 EXP 4/00, E6172 EXP 2/00, H3896 EXP 4/00.
MANUFACTURER Merck and Company, Inc., West Point, Pennsylvania.
DISTRIBUTION Nationwide.
QUANTITY 15,424 bottles were distributed.
REASON Dissolution failure for Hydrochlorothiazide.

PRODUCT Hibistat Germicidal hand rinse, (Chlorhexidine gluconate), 0.5% w/w, OTC, used by health care professional as a germicidial hand rinse. NDC #0310-0575-08.
CODE Lot #3152B EXP 4/01.
MANUFACTURER Accupac, Inc., Mainland, Pennsylvania.
RECALLED BY AstraZeneca, a business unit of Zeneca, Inc., Wilmington, Delaware
DISTRIBUTION Nationwide and Saudi Arabia.
QUANTITY 33,432 bottles were distributed.
REASON Alcohol low potency and specific gravity failure; rework without current good manufacturing practice control.

PRODUCT Spectinomycin Dihydrochloride Pentahydrate, Bulk Drug Substance, Rx non-sterile special grade bulk antibiotic.
CODE Lot Numbers: 53-049-CD, 53-059-CD, 53-060-CD, 53-061-CD, 53-085-CD, 53-086-CD, 53-087-CD, 53-088-CD and 54-188-CD.
MANUFACTURER Abbott Laboratories, Inc., Chemical and Agricultural Products Division, North Chicago, Illinois.
DISTRIBUTION Italy, Switzerland, France, Hong Kong, Korea, Taiwan.
QUANTITY 4,459.04-kg of bulk drug substance were distributed.
REASON Iron contamination.

PRODUCT Warrick Pharmaceuticals brand of Albuterol, USP, Inhalation Aerosol, 17 g, 200 metered inhalations, Rx for the prevention and relief of bronchospasm. NDC: 59930-1560-1 NDC: 59930-1560-2 (Batch 9-BBS-551 only, batch package without mouthpiece as a refill presentation).
CODE
Batch        Expiry
9-BBS-540 3/01
9-BBS-548 4/01
9-BBS-549 4/01
9-BBS-550 4/01
9-BBS-551 4/01
9-BBS-552 4/01
9-BBS-553 4/01
9-BBS-554 4/01
9-BBS-555 4/01
9-BBS-556 4/01
9-BBS-557 5/01
9-BBS-558 5/01
9-BBS-559 5/01
9-BBS-560 5/01
9-BBS-561 5/01
9-BBS-562 5/01
9-BBS-563 5/01
9-BBS-564 5/01
9-BBS-565 5/01
9-BBS-566 5/01
9-BBS-567 5/01
9-BBS-568 5/01
9-BBS-569 5/01
9-BBS-570 5/01
9-BBS-572 6/01
9-BBS-573 6/01
9-BBS-574 6/01
9-BBS-811 2/01
9-BBS-817 4/01
9-BBS-818 4/01
9-BBS-819 4/01
9-BBS-820 4/01
MANUFACTURER Schering Laboratories, Inc., Kenilworth, New Jersey. (Note: Warrick Pharmaceuticals Corp. is the generic pharmaceutical marketing subsidiary of Schering Plough Corporation).
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY
Batch Number Quantity Shipped(Units)
9-BBS-540     192,582
9-BBS-548     190,935
9-BBS-549     194,760
9-BBS-550     190,740
9-BBS-551     145,522
9-BBS-552     187,689
9-BBS-553     190,337
9-BBS-554     186,336
9-BBS-555     186,870
9-BBS-556     187,698
9-BBS-557     187,920
9-BBS-558     189,288
9-BBS-559     188,352
9-BBS-560     190,752
9-BBS-561     191,652
9-BBS-562     186,984
9-BBS-563     190,254
9-BBS-564     188,825
9-BBS-565     188,784
9-BBS-566     189,070
9-BBS-567     185,303
9-BBS-568     184,968
9-BBS-569     190,080
9-BBS-570     188,519
9-BBS-572     107,472
9-BBS-573     104,939
9-BBS-574       23,642
9-BBS-811       23,448
9-BBS-817     109,016
9-BBS-818     108,846
9-BBS-819     109,077
9-BBS-820     107,064
REASON Insert mislabeling; insert incorrectly instructs user to only use with orange mouth piece, while product is accompanied by white mouthpiece, the correct color.
 

WEEK ENDING DECEMBER 10

PRODUCT Requip (Ropinirole Hydrochloride) 1 mg tablets, in bottles of 100, Rx for the treatment of Parkinsonís disease. NDC #0007-4892-20
CODE
LOT NUMBERS EXP. DATES
716550                     9/30/99
716410                     10/31/99
716420                     10/31/99
716560                     10/31/99
717810                     1/31/00
769070                     6/30/00
768910                     6/30/00
769340                     6/30/00
779810                     6/30/00
779820                     6/30/00
779830                     6/30/00
779840                     7/31/00
002446                     11/30/99
002447                     11/30/99
003351                     1/30/00
003352                     1/31/00
004019                     2/28/00
004102                     2/28/00
004906                     3/31/00
004907                     3/31/00
005399                     4/30/00
005727                     4/30/00
006293                     4/30/00
006294                     4/30/00
007003                     5/31/00
007004                     5/31/00
007496                     5/31/00
007497                     5/31/00
007816                     5/31/00
007902                     5/31/00
007817                     6/30/00
007903                     6/30/00.
MANUFACTURER SmithKline Beecham Pharmaceuticals, Crawley, West Sussex RH102QJ.
RECALLED BY SmithKline Beecham Pharmaceuticals, Philadelphia, Pennsylvania
DISTRBIUTION Nationwide.
QUANTITY Approximately 20,000 bottles were distributed.
REASON Tablets have been found to fade from green to yellow, making it difficult to distinguish between strengths or could cause the wrong product to be dispensed.
 

WEEK ENDING DECEMBER 17

PRODUCT Warrick Pharmaceuticals brand Albuterol, USP Inhalation Aerosol, 17 g, 200 metered inhalations, Rx indicated for the prevention and relief of bronchospasm in patients with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm.
CODE NDC #59930-1560-1; Batch #9-BBS-525 EXP 8/01.
MANUFACTURER Schering Laboratories, Inc., Kenilworth, New Jersey.
DISTRIBUTION Alabama, Connecticut, Florida, Georgia, Kentucky, Maryland, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Tennessee, Virginia, West Virginia.
QUANTITY 190,679 units were distributed; firm estimates none remains on the market.
REASON Some units fail to contain active ingredient.

PRODUCT Rugby Hemorrhoid Preparation Suppositories in cardboard box containing 12 suppositories, OTC, used to temporarily shrink hemorrhoidal tissue and relieve the itching, burning and discomfort associated with hemorrhoids.
CODE Lot #906226, #908222
MANUFACTURER Hi-Tech Pharmacal, Inc., Amityville, New York.
RECALLED BY Rugby Laboratories, Norcross, Georgia
DISTRIBUTION Georgia, Indiana, Kentucky, Michigan, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Texas.
QUANTITY 1,182 boxes were distributed; firm estimated that 250 boxes remained on market at time of recall initiation.
REASON Labeling - Product lacks pregnancy-nursing warning.

PRODUCT Various Human Drugs:
1. Ascorbic Acid Injection, 222 mg/mL, 30 mL vial, 4 lots NDC #30727-645-80 for MERIT PHARMACEUTICALS
2. Ascorbic Acid Injection, 500 mg/mL, 50 mL vial, 4 lots NDC #0402-1083-50 for STERIS LABS label
NDC #49072-039-50 for McGUFF COMPANY label NDC #11694-206-50 for KEY label
3. Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL vial, NDC #0402-0191-30 for STERIS LABS labelNDC #0364-6559-56 for SCHEIN PHARMACEUTICAL NDC #0839-5628-36 for MOORE MEDICAL label NDC #0536-2501-75 for RUGBY LABORATORIES label
4. Bacteriostatic Water for Injection, USP, 30 mL vial, NDC #0402-1057-30 for STERIS LABS label NDC #66467-2611-3 for DARBY GROUP label NDC #0839-5180-36 for MOORE MEDICAL label NDC #0536-2620-75 for RUGBY LABORATORIES label
5. Chorionic Gonadotropin for Injection, USP, 5,000 USP units, Lyophilized With Diluent, 10 mL vial set, NDC #0402-0125-10 for STERIS LABS label NDC #57548-125-10 for EVEREADY label NDC #44087-8005-3 for SERONO LABORATORIES label
6. Chorionic Gonadotropin for Injection, USP, 10,000 USP units, Lyophilized With Diluent, 10 mL vial set, NDC #0402-0126-10 for STERIS LABS label NDC #0364-6706-54 for SCHEIN HARMACEUTICAL label NDC #44087-8010-3 for SERONO LABORATORIES label NDC #0182-1165-63 for ZENITH-GOLDLINE LABORATORIES label NDC #99012-126-10 for R. W. ENTERPRISES label
7. Edetate Disodium Injection, USP, 3g/20 mL (150 mg/mL), 20 mL vial, NDC #0402-0277-20 for STERIS LABS label NDC #0364-2485-55 for SCHEIN PHARMACEUTICAL label NDC #49072-177-20 for McGUFF COMPANY label NDC #0456-0724-17 for FOREST PHARMACEUTICAL label NDC #30727-318-65 for MERIT PHARMACEUTICALS label NDC #11694-720-20 for KEY COMPANY label
8&9.. Gentamicin Sulfate Injection, USP, 80 mg/2 mL, 2 mL vial; and Gentamicin Sulfate Injection, USP, 40 mg/mL, 20 mL vial, NDC #0402-0559-02 for STERIS LABS label [2 ml SIZE] NDC #0364-6739-48 for SCHEIN PHARMACEUTICAL label [2 ml SIZE] NDC #66467-4685-9 for
DARBY GROUP label [2 ml SIZE] NDC #0182-1424-61 for ZENITH-GOLDLINE LABORATORIES label NDC #0536-4690-67 for RUGBY LABORATORIES label [2 ml SIZE] NDC #0839-6503-23 for MOORE MEDICAL label [2 ml SIZE] NDC #0402-0559-20 for STERIS LABS label [20 ml SIZE] NDC #0182-1424-65 for ZENITH-GOLDLINE LABORATORIES label [20 ml SIZE] NDC #66467-4685-2 for DARBY GROUP label [20 ml SIZE] NDC #0364-6739-55 for SCHEIN PHARMACEUTICAL label [20 ml SIZE] NDC #0536-4690-73 for RUGBY LABORATORIES label
10. Metoprolol Tartrate Injection, USP, 5 mg/5mL, 5 mL vial, NDC #0364-3036-25 for SCHEIN PHARMACEUTICAL label
11. Neomycin and Polymyxin B Sulfates Solution for Irrigation, USP, 1 mL Ampul, NDC #0364-2190-41 for SCHEIN PHARMACEUTICAL label
12. Phenylephrine Hydrochloride Ophthalmic Solution, USP, 10%, 5 mL dropper bottle, NDC #0402-0799-05 for STERIS LABS label NDC #0364-2370-53 for SCHEIN PHARMACEUTICAL label NDC #51394-226-10 for WILSON OPHTHALMICS label NDC #54799-531-05 for OCUSOFT label
13. Vecuronium Bromide for Injection 10 mg, lyophilized powder, 10 mL vial, NDC #0209-9140-22 for MARSAM PHARMACEUTICAL label NDC #0209-9140-92 for MARSAM PHARMACEUTICAL label NDC #0209-9141-26 for MARSAM PHARMACEUTICAL label
14. Vecuronium Bromide for Injection 20 mg, lyophilized powder, 20 mL vial, NDC #0209-9143-22 for MARSAM PHARMACEUTICAL labelNDC #0209-9143-92 for MARSAM PHARMACEUTICAL label.
CODE Lot Numbers:
1. 96H760, 97C790, 97G780, 98A070
2. 98C840, 98D140, 98D360, 98D580
3. 97C580
4. 96N430, 97D950, 98B530
5. 97L910
6. 97K710, 98B550, 97J410, 97J510
7. 96K880, 96F890, 96M330, 96M700, 96N600, 96N750, 97A150, 97A650, 97B010, 97E260, 97E410, 97G060, 97K510, 98B310, 98C050, 98C670, 96N740, 97A510, 97B500
8&9 [for 2 ml SIZES]: 96K870, 97B550, 97G240; [for 20 ml SIZES]: 97A570, 97C210, 97G290
10. 97J300 97J350 97J360 97J590 97K470 97L290 97M320 98A910 98B570 98C250 98C890 98D150 98D380 98E120 98D740 98E530 98F150
11. 96L260, 97B320, 97B910, 97F160, 97F220, 97J110, 97J320, 97K040, 98A350, 98A830, 98B190
12. 96L290, 97C660, 97J100, 97J840, 98D880
13. 98B770, 98C150, 98C270, 98C340, 98C530, 98C700, 98D080, 98D200, 98D250, 98D300, 98D460 98D621, 98D760, 98E190, 98E350, 98E600, 98E880, 98F010, 98F090, 98F180
14. 98B780, 98C390, 98D110, 98D260, 98D770, 98E220, 98E640.
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.
DISTRIBUTION Nationwide and international.
QUANTITY
1. 64,689 units
2. 71,930 units
3. 30,797 units
4. 64,151 units
5 10,494 units
6. 91,684 units
7. 1,322,117 units
8&9) 439,139 units
10. 1,015,520 units
11. 876,375 units
12. 150,242 units
13. 854,561 units
14. 72,130 units
REASON Current good manufacturing practice deviations - Lack of data to support process validation(s) and defect investigations.

PRODUCT Diabeta® (Glyburide) 5mg, 100 tablet bottles, Rx, for use as an adjunct to diet to lower the blood glucose in patients with non insulin-dependent diabetes mellitus (Type II), packaged in 24 bottles/intermediate box, 4 intermediate boxes/shipping case. NDC #0039-0052-10.
CODE Lot Number 0017181, EXP 6/2001.
MANUFACTURER Med-Pro, Inc., Lexington, Nebraska (repacker).
DISTRIBUTION New York.
QUANTITY 840 100-tablet bottles were distributed.
REASON Immediate bottle label shows two strengths 5 MG and 25 MG.

PRODUCT Compressed Medicinal Oxygen in Steel Tanks, (E, D, and M size), Rx drug for breathing therapy
CODE Various lots produced between 8/7/98 and 8/17/99.
MANUFACTURER Option Care, Covington, Georgia.
DISTRIBUTION Georgia.
QUANTITY 6,000 cylinders were distributed.
REASON Current good manufacturing practice deviations, including but not limited to lack of oxygen assays.

PRODUCT M.V.I.® Pediatric (Multiple Vitamins for infusion), in 10 mL Single Dose Vial
CODE Lot Numbers 9F3009, EXP 3/00, 9F3011 EXP 4/00.
MANUFACTURER Catalytica Pharmaceuticals, Greenville, North Carolina.
RECALLED BY AstraZeneca Inc., Westborough, Massachusetts
DISTRIBUTION Tennessee, Arizona.
QUANTITY 9,163 units of Lot #9F3009 and 9,143 units of Lot #9F3011 were distributed.
REASON Subpotent (vitamin A, K, Dexpanthenol and/or Pyridoxine).

PRODUCT Triamcinolone Acetonide Cream 0.1% in 1 pound jars, under the following labels: NMC Laboratories; - NDC 23317-301-16; Rugby Laboratories - NDC 0536-5225-98; Major Pharmaceuticals, - NDC 0904-2741-27 Schein Pharmaceuticals - NDC 0364-7212-16.
CODE
Lot # EXP Label
6I561 09/99 NMC
6K705 11/99 Rugby
6I571 09/99 NMC
6K707 11/99 Rugby
6I576 09/99 NMC
6K715 11/99 NMC
6I578 09/99 NMC
6K716 11/99 NMC
6I581 09/99 NMC
6K724 11/99 NMC
6I623 09/99 NMC
6K750 11/99 NMC
6J626 10/99 NMC
6L744 12/99 NMC
6J627 10/99 NMC
6L775 12/99 NMC
6J636 10/99 NMC
6L793 12/99 NMC
6J657 10/99 Major & NMC
6L794 12/99 NMC
6L820 12/99 NMC
6J673 10/99 NMC
7A847 01/00 NMC
6J674 10/99 Schein
MANUFACTURER Alpharma USPD, Inc., Lincolnton, North Carolina.
DISTRIBUTION Nationwide.
QUANTITY 102,381 units were distributed; firm estimated that very little product remained on market at time of recall initiation based on EXP dates.
REASON Lack of assurance that product will meet potency specification over labeled expiration date (superpotency).

PRODUCT Clobetasol Propionate Topical Solution, USP, 0.05%, in 25 and 50 mL bottles, Rx used as a topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp
CODE
Lot Size (mL) Exp
RJ7557 50 9/99
RJ7558 50 9/99
VK7642 50 9/99
VL7660 50 10/99
VN7754 25 11/99
VN7754 50 11/99 (H.L.Moore)
RP7931 25 11/99
RP7931 50 11/99
RS7974 25 01/00
RS7974 50 01/00
RA8012 50 03/00
RB8028 25 05/00
RA8057 25 02/00
RB8069 50 03/00
RH8170 50 06/00
RC8212 50 05/00
RF8413 50 06/00.
MANUFACTURER Alpharma USPD, Inc., Baltimore, Maryland.
DISTRIBUTION Nationwide.
QUANTITY 345,462 units under Alpharma label and 3,564 units (50 mL) under the H.L. Moore label were distributed.
REASON Exceeding USP total related substances testing prior to expiration date.

PRODUCT Norco Tablets 10mg/325 mg Hydrocodone Bitartrate/ Acetaminophen, Physician Samples, Cartons of 30’s containing 15 units of 2 tablets, Rx indicated for the relief of moderate to moderately severe pain in humans. NDC #52544-539-30
CODE
LOT NUMBER EXPIRATION DATE
53902R96F         11/1998
53903R96F         11/1998
53901R96F         11/1998
53904R96F         11/1998
53904J98F           09/2000
53903M98F         10/2000
53910M98F         10/2000
53901R98F         11/2000
53904R98F         11/2000
53901A99F         01/2001
53902A99F         01/2001
53903A99F         01/2001
53904A99F         01/2001
53901C99F         03/2001.
MANUFACTURER Watson Laborataories, Inc., a subsidiary of Watson Pharmaceuticals, Inc., Corona, California.
DISTRIBUTION Nationwide.
QUANTITY 222,472 cartons (15 2-tablet pouches per carton) were distributed.
REASONLabeling lacks approval.

PRODUCT Klonopin (brand of Clonazepam) Tablets, in bottles of 100 tablets Rx used in the treatment of seizure disorders: a) 0.5 mg, NDC `0004-0068-01; b) 1.0 mgm, NDC #0004-0058-01; c) 2.0 mg, NDC #0004-0098-01.
CODE
LOT NO. EXP DATE
U0003 11/2000
U0004 11/2000
U0501 12/2000
U0502 12/2000
U1002 11/2000.
MANUFACTURER Roche Pharma, Inc., Humacao, Puerto Rico.
RECALLED BY Roche Laboratories, Inc., Nutley
DISTRIBUTION Nationwide.
QUANTITY Approximately 79,013 units of all three strengths were distributed.
REASON Product had incorrect expiration date on label.

PRODUCT Lidocaine and Epinephrine Injection, USP (Lidocaine HCl 2% and Epinephrine 1:100,000 and 1:50,000) and Mepivacaine Hydrochloride and Levonordefrin Injection, USP (Mepivacaine HCl 2% and Levonordefrin 1:20,000). The products are shipped in 1.8 ml cartridges with 50 cartridges per box.
CODE
a) Lidocaine 100:
Lot # 8050 EXP 10/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8051 EXP 10/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8055* EXP 10/99 under Henry Schein label
Lot # 8056* EXP 10/99 under Henry Schein label
Lot # 8057 EXP 10/99 under Henry Schein label
Lot # 8064 EXP 10/99 under Henry Schein label
Lot # 8065 EXP 10/99 under Henry Schein label
Lot # 8066 EXP 10/99 under Meer Dental label
Lot # 8067 EXP 10/99 under Carlisle Laboratories label
Lot # 8068 EXP 10/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8069 EXP 10/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8071 EXP 10/99 under Meer Dental label
Lot # 8072 EXP 11/99 under Meer Dental label
Lot # 8073 EXP 11/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8074* EXP 11/99 under Carlisle Laboratories label
Lot # 8075 EXP 11/99 under Carlisle Laboratories label
Lot # 8076 EXP 11/99 under Carlisle Laboratories label
Lot # 8077 EXP 11/99 under Carlisle Laboratories label
Lot # 8078 EXP 11/99 under Carlisle Laboratories label
Lot # 8079 EXP 11/99 under Carlisle Laboratories label
Lot # 8080* EXP 11/99 under Carlisle Laboratories label
Lot # 8081* EXP 11/99 under Carlisle Laboratories label
Lot # 8082* EXP 11/99 under Carlisle Laboratories label
b) Lidocaine 50:
Lot # 8058 EXP 10/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8059C EXP 10/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8060 EXP 10/99 under Henry Schein label
Lot # 8083 EXP 11/99 under Carlisle Laboratories label
Lot # 8086B* EXP 11/99 under Patterson Dental label
c) Mepivacaine 2%:
Lot # 8063B EXP 10/99 under Meer Dental label (Henry Schein now owns)
Lot # 8063C EXP 10/99 under Novocol label (distributed by Septodont, Inc)
Lot # 8063D EXP 10/99 under Carlisle Laboratories label
* Indicates that the lot was involved in recall D-188/91-9.
MANUFACTURER Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada.
RECALLED BY Septodont, Inc., New Castle, Delaware
DISTRIBUTION Nationwide.
QUANTITY 52 boxes.
REASON Subpotent (Ephinehrine/Levonordefrin).

PRODUCT Pepcid (Famotidine) Tablets, 20 mg repacked in unit dose blisters, Rx, overpackaged by Haines Pharmaceuticals.NDC #0006-0963-28
CODE Lot #4616 EXP 10/99.
MANUFACTURER Haines Pharmaceuticals Division, IMDS, Inc., Pompano Beach, Florida (repacker/responsible firm).
RECALLED BY AmeriSource Health Services Corporation, doing business as American Health Packaging, Columbus, Ohio
DISTRIBUTION Ohio, Massachusetts, Tennessee.
QUANTITY 750 bags (75,000 individual units) were distributed; firm estimates none remains on the market.
REASON Repacking error - Some units may contain a multivitamin.

PRODUCT Tebamide (tm) Suppositories (Trimethobenzamide), 200 mg, in boxes of 10 and 50, Rx used to control nausea and vomiting.
CODE Product Code 0108
Lot Numbers EXP Date NDC Numbers Label
7025-5 02/00 0713-0108-50 G & W (50s)
0713-0108-09 G & W (10s)
0904-2736-15 Major (I Os)
0364-7348-10 Schein (I Os)
7072-5 03/00 0713-0108-09 G & W (10s)
0904-2736-15 Major (I Os)
0364-7348-10 Schein (1 Os)
7226-2 09/00 0713-0108-09 G & W (10s)
0364-7348-10 Schein (I Os)
8173-1 07/01 0713-0108-09 G & W (10s)
0713-0108-50 G & W (50s)
0904-2736-15 Major (I Os)
0364-7348-10 Schein (I Os)
8173-2 07/01 0713-0108-09 G & W (10s)
0713-0108-50 G & W (50s).
MANUFACTURER G&W Laboratories, Inc., South Plainfield, New Jersey.
DISTRIBUTION Nationwide.
QUANTITY
Lot Number Package Size Units/Boxes Distributed
7025-5 50's 1,896 units
7025-5 10's 29,160 units
7072-5 10's 37,872 units
7226-2 10's 38,448 units
8173-1 10's 26,088 units
8173-1 50's 1,800 units
8173-2 10's 32,256 units
8173-2 50's 1,296 units.
REASON Subpotency of Benzocaine and/or lack of assurance Benzocaine levels will remain within specification over labeled expiration date.

PRODUCT Fluocinonide Cream USP, 0.05%, in 30 gram tubes, Rx used as a topical corticosteroid, which has anti-inflammatory, anti-prurtic and vasoconstrictive actions
CODE Lot #7F306 EXP 6/00.
MANUFACTURER Taro Pharmaceuticals, Bramalea, Ontario, Canada.
RECALLED BY Taro Pharmaceuticals USA, Inc., Hawthorne, New York
DISTRIBUTION Arkansas, Arizona, California, Colorado, Connecticut, Georgia, Illinois, Louisiana, Maine, Minnesota, New Jersey, New York, Pennsylvania, Tennessee.
QUANTITY 10,032 30-gram tubes were distributed.
REASON Subpotency at 24 month stability.
 

WEEK ENDING DECEMBER 31

PRODUCT Forest Levothroid Tablets (levothyroxine sodium tablets, USP), Rx, indicated as replacement or substitution therapy for diminished or absent thyroid function:
a) LevothroidÆ Tablets (Levothyroxine Sodium), 75 mcg, 100 count. NDC #0456-0322-01
b) LevothroidÆ Tablets (Levothyroxine Sodium), 100 mcg, 100 count. NDC #0456-0323-01
c) LevothroidÆ Tablets (Levothyroxine Sodium), 125 mcg, 100 count. NDC #0456-0324-01
d) LevothroidÆ Tablets (Levothyroxine Sodium), 137 mcg, 100 count. NDC #0456-0331-01
e) LevothroidÆ Tablets (Levothyroxine Sodium), 150 mcg, 100 count. NDC #0456-0325-01
f) LevothroidÆ Tablets (Levothyroxine Sodium), 175 mcg, 100 count. NDC #0456-0326-01
g) LevothroidÆ Tablets (Levothyroxine Sodium), 200 mcg, 100 count. NDC #0456-0327-01
CODE
Lot Numbers: a) 10984, 10985, 11981, and 11982 EXP 11/00
b) 19914, 19912, and 19913 EXP 01/01
c) 109810 EXP 10/00, 19917 EXP 01/01, 1991 EXP 07/00,19919 EXP 01.01, and 19918 EXP 01/01
d) 109811 EXP 10/00, and 2994 02/01
e) 119842 EXP 12/00 and 19926 EXP 01/01
f) 109813 EXP 12/00 and 119844 12/00
g) 99813 EXP 10/00.
MANUFACTURER Forest Pharmaceuticals, Inc., Cincinnati, Ohio.
RECALLED BY Forest Pharmaceuticals, Inc., subsidiary of Forest Laboratories, Inc., St. Louis, Missouri
DISTRIBUTION Nationwide.
QUANTITY 251,347 100-count bottles were distributed.
REASON Subpotent.

PRODUCT Ethex Disopyramide Phosphate Extended-Release Capsules, USP, 150 mg, in 100 capsule bottles, Rx for the treatment of documented ventricular arrhythmias. NDC #58177-002-04
CODE Lot #L14596 EXP 3/29/02.
MANUFACTURER KV Pharmaceutical Company, Maryland Heights, Missouri.
RECALLED BY Ethex Corporation, St. Louis, Missouri
DISTRIBUTION Nationwide.
QUANTITY 6,338 100-capsule bottles were distributed.
REASON Dissolution failure (6 month stability-12th hour).

PRODUCT Fluocinolone Acetonide Topical Solution, USP, 0.01%, in 20 and 60 mL bottles, Rx non-sterile, topical solution used to treat corticosteroid-responsive dermatoses.
CODE All lot numbers within Expiration date.
MANUFACTURER Bausch and Lomb Pharmaceuticals, Inc., Tampa, Florida.
DISTRIBUTION Nationwide.
QUANTITY 219,079 units were distributed; firm estimated that 37,000 units remained on market at time of recall initiation.
REASON Subpotency.

PRODUCT DepoCyt(tm) (Cytarabine liposome injection), 50 mg/mL (10 mg/mL), in 5 mL sterile, single use vial, Rx cytotoxic anticancer drug. NDC #53905-331-01.
CODE Lot #99-0004 and 99-0004A,
MANUFACTURER SkyePharm, Inc., San Diego, California.
RECALLED BY Chiron Corporation, Emeryville, California
DISTRIBUTION Nationwide.
QUANTITY 569 vials were distributed.
REASON Product failed % free cytarabine specification (6 month stability).

PRODUCT HemoridÆ Hemorrhoidal Suppositories, (Zinc Oxide 11%/Phenylephrine Hydrochloride 0.25%), in boxes of 12.
CODE All unexpired lots.
MANUFACTURER G&W Laboratories, Inc., South Plainfield, New Jersey.
RECALLED BY Consumer Health Care Group, Parsippany, New Jersey (own label Distributor)
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 1,227,948 units were distributed; firm estimates none remains on the market.
REASON Subpotency of phenylephrine (stability testing).

PRODUCT Trilisate Tablets (Choline Magnesium Trisalicylate), 750 mg, 500 count bottles, Rx non-sterodial anti-inflammatory, analgesic and anti-pyretic preparation. NDC #0034-0505-50.
CODE LOT #71G1 EXP 3/01.
MANUFACTURER The P.F. Laboratories Totowa, New Jersey. (responsible firm).
RECALLED BY The Purdue Frederick Company, Inc., Norwalk, Connecticut
DISTRIBUTION Nationwide.
QUANTITY 792 bottles were distributed. Firm estimated that 359 bottles remained on market at time of recall initiation.
REASON Subpotent (choline content).

PRODUCT LevsinÆ Injection (hyoscyamine sulfate), 0.5mg per mL, 1 mL ampuls, Rx intended for use for gastrointestinal disorders, diagnostic procedures, and anesthesia. NDC #0091-1536-05.
CODE Lot Numbers: 35281 and 35282 EXP 9/00.
MANUFACTURER Taylor Pharmaceuticals, Decatur, Illinois.
RECALLED BY Schwarz Pharma Mfg, Inc., Seymour, Indiana
DISTRIBUTION Nationwide and Republica Dominicana.
QUANTITY 9,296 cartons (5 ampules per box) were distributed.
REASON Subpotent (18 month stability testing).

PRODUCT Medi-First Extra Strength Non-Aspirin Acetaminophen 500 mg, OTC pain reliever, packaged in 2 tablet unit dose packets.NDC #47682-804-99.
CODE Lot #2091 EXP 7/03.
MANUFACTURER Future Pak Ltd., Farmington Hills, Michigan (packet packager).
RECALLED BY Textilease Medique, Inc. (TMI), Skokie, Illinois (repacker)
DISTRIBUTION Colorado, California, Texas, Missouri, Arkansas, Wisconsin, Alabama, Michigan, Indiana, Tennessee, Florida, Georgia, South Carolina, Illinois.
QUANTITY 448 cartons were distributed; firm estimated that 25 percent of product remained on market at time of recall initiation.
REASON Mislabeling - Exterior holding/dispensing cartons labeled as non-aspirin ibuprofen 200 mg.

PRODUCT e-LUDESô Capsules (kava kava, guarana, grape seed, uva ursi, corn silk, cascara segrada), OTC in 12 count packages
CODE All lots.
MANUFACTURER Spectrum Distribution & Marketing, Inc., Beverly Hills, California (own label distributor/responsible firm).
DISTRIBUTION Undetermined
QUANTITY Approximately 288 units were distributed.
REASON Product was marketed without an approved new drug application.

PRODUCT Tinactin Antifungal Powder (tolnaftate 1%), in 45, 90, and 108 gram shaker bottles, OTC topically applied antifungal powder.
CODE 45 Gram: 8E15AAG, 8E16AG, 8E17AG, 8E18AG, 8H16AAG, 8H17AG, 8K24AAG, 8M03AG, 8N12AG
90 Gram: 8E10AG, 8E11AG, 8E13AG, 8E14AG, 8E15AG, 8E12AG, 8E18AAG, 8G01AG, 8G01AAG, 8H13AG, 8H14AG, 8H15AG, 8H16AG
100 Gram: 9A06AG, 9A07AG, 9A08AG.
MANUFACTURER Ash Corporation, Gulfport, Mississippi.
RECALLED BY Schering-Plough HealthCare, Memphis, Tennessee
DISTRIBUTION Nationwide.
QUANTITY 428,000 units of the three sizes were produced.
REASON Subpotent (stability).