WEEK ENDING NOVEMBER 10
PRODUCT a) Qualitest brand Prednisone Tablets,
10 mg, in 21 and 48 count, unit dose pack, NDC #0603-5333-31 and 0603-5333-15;
b) Dexamethasone Tablets, USP, 0.75 mg, 12 count, unit
dose pack, under the Qualitest and Vintage labels.
CODE Lot Numbers: a) 071F0A and 071F0B; b) Qualitest
Dexamethasone Tablets, USP, 0.75mg, NDC #0603-3191-11, Lot numbers: 022D9A,
022D9B, 022D9C, 022D9D, 022D9E, 014E9A, 014E9C, 014E9D, 053F9A, 052L9B,
052L9C Dexamethasone Tablets, USP, 0.75mg, NDC #0254-2667-06, Lot numbers:
022D9F, 014E9B, 014E9E, 052L9A Vintage Dexamethasone Tablets, USP, 0.75mg,
Rx, NDC #0254-2667-06, Lot numbers: 014E9B, 014E9E, 052L9A, 022D9F.
MANUFACTURER Vintage Pharmaceuticals, Inc., Huntsville,
Alabama.
DISTRIBUTION a) Nationwide; b) Nationwide and Puerto
Rico.
QUANTITY a) 4,483 packages; b) 179,728 packages were
distributed.
REASON Lack of data to support labeled expiration date.
PRODUCT Morphine Sulfate Injection, USP (with additive),
Rx for the relief of severe pain:
a) 1 MG/ML, NDC 61703-219-75 (30 ML (LONG) X 1 VIAL)
NDC 61703-219-80 (10 ML X 1 VIAL)
NDC 61703-219-85 (30 ML (SHORT) X 1 VIAL)
b) 5 MG/ML NDC 61703-221-75 (30 ML (LONG) X 1 VIAL)
NDC 61703-221-85 (30 ML (SHORT) X 1 VIAL)
c) 10MG/ML NDC 61703-231-32 (10 ML X 10 VIALS)
d) 25 MG/ML NDC 61703-223-21 (20 ML X 10 VIALS)
NDC 61703-223-43 (40 ML X 10 VIALS)
e) 50 MG/ML NDC 61703-225-21 (20 ML X 10 VIALS)
NDC 61703-225-43 (40 ML X 10 VIALS).
CODE
LOT NO.
EXP. DATE
8151
9/00
8151039
11/00
8152-33, 36, 37 10/00
8152-38
11/00
8153-29, 32
9/00
8153-35
10/00
81510-31
9/00
9151-1, 1A
12/00
9151-9
3/01
9151-15, 21, 25 4/01
9151-26
7/01
9151-32, 35
8/01
9151-46, 56
10/01
9151-57, 59
11/01
9152-4, 7
2/01
9152-11, 12, 13
3/01
9152-23, 24
4/01
9152-34, 36
8/01
9152-48
10/01
9152-62
11/01
9153-3
1/01
9153-10, 14
3/01
9154-8
3/01
9154-50
10/01
9156-42
9/01
9157-33
8/01
9157-43
10/01
9157-58
11/01
9158-18
4/01
9159-5
2/01
9159-16, 20
4/01
9159-22
5/01
9159-28
7/01
9159-31
8/01
9159-38, 39, 40 9/01
9159-49
10/01
9159-51, 52, 61 11/01
91510-2, 6
1/01
91510-17, 19
4/01
91510-29
6/01
91510-30
8/01
91510-37, 41, 44, 45 9/01
91510-53, 54
10/01
91519-55
11/01
0151-4, 5
12/01
0151-21, 23, 24
2/02
0152-9, 10, 16
1/02
0152-25
2/02
0152-28, 31
3/02
0153-1
12/01
0153-12
1/02
0155-22
2/02
0156-2
12/01
0156-17
1/02
0157-6
12/01
0157-29
3/02
0158-7
12/01
0159-3, 8
12/01
0159-11, 13
1/02
0159-32, 33
4/02
01510-19, 20
2/02.
MANUFACTURER Faulding Pharmaceutical PR, Inc., Aguadilla,
Puerto Rico.
DISTRIBUTION Nationwide.
QUANTITY Approximately 285,343 units were distributed.
REASON Misbranding - Product labeled to contain 0.1%
sodium bisulfite rather than the actual amount of 0.2%.
PRODUCT a) Doxycycline Hyclate Capsules, USP, 50
mg, in bottles of 50, NDC #0364-2023-50; b) Doxycycline Hyclate Capsules,
100 mg, in bottles of 50 and 500, NDC #0364-2033-05, Schein Pharmaceutical
label.
CODE Lot Numbers: P9H0299 EXP AUG 01 and P9E0179 EXP
MAY 01.
MANUFACTURER Danbury Pharmacal of Puerto Rico, Inc.,
Subsidiary of Schein Pharmaeutical, Inc., Humacao, Puerto Rico.
DISTRIBUTION Nationwide and international.
QUANTITY 7,590 bottles of 50 (lot P9H0299); 28,205 bottles
of 50 (lot P9E0179) and 2,888 bottles of 500 (lot P9E0179) were distributed.
REASON Product exceeds USP limit for water content.
WEEK ENDING NOVEMBER 17
PRODUCT Trasylol (aprotinin injection), 10,000
K.I.U./mL, 100 and 200 ml Sterile Solution, for intravenous infusion, Rx
indicated for prophylactic use to reduce perioperative blood loss and the
need for blood transfusion in patients undergoing cardiopulmonary artery
bypass graft surgery.
CODE Lot Numbers: ODIA EXP 01/02, OEHB EXP 01/02, OEFM
EXP 01/02.
MANUFACTURER Bayer AG, Leverkusen, Germany.
RECALLED BY Bayer Corporation, Pharmaceutical Division,
West Haven, Connecticut
DISTRIBUTION Nationwide.
QUANTITY 29,514 units were distributed.
REASON Lack of assurance of sterility.
WEEK ENDING NOVEMBER 24
PRODUCT Rich's MSM Eye and Ear Drops (Methylsufonylmethane),
in 1-ounce bottles.
CODE All product (Product not coded).
MANUFACTURER Rich Distributing, Portland, Oregon.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON Microbial contamination (Pseudomonal fluorescens).
PRODUCT Tia-Cutz Capsules, Thyroid Stimulator,
(1000 mcg Tiratricol), in 90-count containers, OTC indicated for use in
weight loss and in conditions of obesity.
CODE Lot 990426 EXP 12/01.
MANUFACTURER Ultra Health Products, Phoenix, Arizona.
RECALLED BY Gentech LLC, doing business as Gaspari Nutrition),
Edison, New Jersey (responsible firm
DISTRIBUTION Nationwide.
QUANTITY 1,569 bottles were distributed; firm estimates
none remains on the market.
REASON Product is an unapproved new drug.
PRODUCT Sterile Talc Powder, in 100 mL vials, used
to treat Malignant Pleural Effusion (MPE).
CODE All lot numbers as follows: Non-sterile lot numbers:
9H010 and 9K012 Unapproved New Drug lot Numbers:
Distribution Began Lot Number
10/14/97 (2 yr.exp.date) 7I008
03/27/98 8B004
07/31/98 8E005
11/18/98) 8I007
3/3/99 9B003
6/4/99 9D004
3/30/00 0A002
6/5/00 0E006.
MANUFACTURER Sciarra Laboratories, Hicksville, New York.
RECALLED BY Bryan Corporation, Woburn, Massachusetts
DISTRIBUTION Nationwide and Canada.
QUANTITY Lot 9H010= 545 Cases (10 each) + 4 each Lot
9K012= 847 Cases (10 each) + 119 each
Estimated at approximately 5,568 cases of the remaining
8 lots were distributed.
REASON Non-sterile product.
PRODUCT a) Eyewash, Emergency Eye/Face Body Wash,
Eyewash Concentrate and Normal Saline as follows:
Lavoptik Brand manufactured by H.L. Bouton, Buzzards
Bay, MA:
Lavoptik Emergency Eye/Face/Body Wash in 16 oz. and 32
oz.
Lavoptik Eye Wash in 6 oz.
Lavoptik Eye Wash Concentrate For use in Portable Eye
Wash Stations in 70 oz. and 180 oz.
Rapid-Clear Brand distributed by Sellstrom, Palatine,
IL:
Rapid-Clear Eye Wash 16 oz., and 32 oz. and 128 oz
Rapid-Clear Eye Wash Concentrate For Use in Portable
Eye Wash Stations 180 oz.
Zee Brand distributed by Zee Medical, Irvine CA
Zee Protector II Refill Sterile Eye Wash Solution for
Use in ZEE
Protector II Eye Wash Station , 5 Qt
b) Normal Saline Solution 16 oz.
CODE All lots.
MANUFACTURER H.L. Bouton Company, Inc., Buzzards Bay,
Massachusetts.
DISTRIBUTION Nationwide.
QUANTITY 40,000-50,000 units were distributed.
REASON Microbial contamination (Bulkholderia cepacia).
PRODUCT Heparin Sodium Injection, USP, 5000 USP
units per 0.5 mL in 1 mL tubex per 10,000 USP units, Rx.
CODE Lot Numbers: 10945 EXP 02/01 and 10962 EXP 02/01.
MANUFACTURER Wyeth-Ayerst Laboratories, Philadelphia,
Pennsylvania (responsible firm).
RECALLED BY AmeriSource Health Services Corporation,
doing business as American Health Packaging (AHP), Columbus, Ohio (repacker/relabeler/distributor)
DISTRIBUTION Ohio, New Jersey, Tennessee, Florida, Minnesota,
Kentucky.
QUANTITY 60 bags (1,500 vials) were distributed.
REASON Lack of assurance of sterility.
PRODUCT Zagam(r) Tablets (Sparfloxacin), 200 mg,
in 55-count bottles, Rx broad spectrum antimicrobial agent.
CODE Lot #MN4062 EXP 11/01.
MANUFACTURER Aventis Pharma Ltd., Republic of Ireland.
RECALLED BY Bertek Pharmaceuticals, Inc., Sugar Land,
Texas
DISTRIBUTION Nationwide.
QUANTITY 105 bottles were distributed; firm estimates
none remains on the market.
REASON Dissolution failure (6 months stability station
testing).
PRODUCT a) Meperidine HCL Injection, USP, 75 mg
per mL, 1 mL fill in 2 mL size, used for the relief of moderate to severe
pain, preoperative medication, support of anesthesia, and obstetrical analgesia.;
b) Heparin Sodium Injection, USP, 5,000 USP units per
0.5 mL fill in 1 mL tubex(r) 10,000 USP units per mL, Rx indicated for
anticoagulant therapy.
CODE Lot Numbers: a) 2990430 EXP 1/01 and 2990431 EXP
1/01; b) 2991816 EXP 2/01.
MANUFACTURER Wyeth Ayerst Laboratories, West Chester,
Pennsylvania.
DISTRIBUTION Nationwide.
QUANTITY a) 350,490 tubexes; b) 186,390 tubexes were
distributed.
REASON Current good manufacturing practice deviations
(lack of assurance of sterility).
PRODUCT Allegra(r) Tablets (fexofenadine HCL),
60 mg, physician sample units, Rx for the releif of symptoms associated
with seasonal allergic rhinitis in adults and children 6 years of age and
older, and for the treatment of uncomplicated skin manifestations of chronic
idiopathic urticaria in adults and children 6 years of age and older.
CODE
Lot #1021570 EXP 032002 Lot #1022502
EXP 102102
Lot #1021572 EXP 101802 Lot #1023169
EXP 110602
Lot #1021573 EXP 102002 Lot #1022714
EXP 032002
Lot #1022501 EXP 102102.
MANUFACTURER Aventis Pharmaceuticals, Inc., Kansas City,
Missouri.
DISTRIBUTION Nationwide.
QUANTITY 207,878/30 2-tablet card boxes were distributed.
REASON Mislabeling - The label bears unapproved dosage
instructions for patients other than adults.
PRODUCT Estratab(r) Tablets (Esterified Estrogens
Tablets, USP), 2.5 mg, in 100-count bottles.
CODE All lots.
MANUFACTURER Solvay Pharmaceuticals, Baudette, Minnesota.
RECALLED BY Solvay Pharmaceuticals, Marietta, Georgia
DISTRIBUTION Nationwide.
QUANTITY 16,418 units were distributed.
REASON Firm withdrawal of application (stability data).
PRODUCT Nortriptyline Hydrochloride Capsules, USP
25 mg, in 500-count bottles, Rx.
CODE Lot #P9E0175 EXP 5/01.
MANUFACTURER Danbury Pharmacal of Puerto Rico, Inc.,
Subsidiary of Schein Pharmaceutical, Inc., Humacao, Puerto Rico.
DISTRIBUTION Nationwide.
QUANTITY 6,756 bottles were distributed.
REASON Dissolution failure (stability).
PRODUCT Pipracil, Rx indicated for the treatment
of serious infections caused by susceptible strains of designated organisms;
Zosyn 3 gram/0.375 gram: indicated for the treatment of patients with moderate
to severe infections caused by peperacillin-resistant, piperacillin/tazobactam-susceptible,
beta-lactamase producing strains of designated microorganisms:
a) Pipracil(r) 3 gram ADD-Vantage(r) vials (Piperacillin
Sodium), For IV Use;
b) Pipracil(r) 4 gram ADD-Vantage(r) vials (Piperacillin
Sodium), For IV Use;
c) Zosyn(r) 3.375 gram ADD-Vantage(r) vials (Sterile
Piperacillin and Sodium Tazobactam Sodium), For IV Use.
CODE Lot Numbers: a) 426-116 EXP 4/01; b) 426-149 EXP
6/01, 464-675 EXP 2/02, 800-118 EXP 6/02; c) 800-048 EXP 4/03.
MANUFACTURER Lederle Piperacillin, Inc., Carolina, Puerto
Rico.
RECALLED BY Wyeth-Ayerst Laboratories, Philadelphia,
Pennsylvania
DISTRIBUTION Nationwide.
QUANTITY Approximately 21,422 units were distributed
between July 1999 - September 2000. (Pipracil 3 gram 5,022 units, Pipracil
4 gram 15,566 units and Zosyn 5, 424 units).
REASON Vial breakage.
PRODUCT Pueblo Xtra brand Isopropyl Alcohol, 70%
Rubbing Alcohol, in 16-fluid ounce bottles.
CODE Lot Numbers: B125 and B143.
MANUFACTURER Omega, Inc., Carolina, Puerto Rico.
DISTRIBUTION Puerto Rico.
QUANTITY 7,200 units were distributed.
REASON Mislabeling - Product bears both the correct label
strength of 70% and an incorrect label declaration of 50%.
PRODUCT a) Duphalac(r) (Lactulose Solution, USP),
10 g/15mL, in 8, 16, and 32-fluid ounce units; b) Duphalac(r) (Lactulose
Solution, USP), 20 g/30mL, in 30mL unit dose cups.
CODE All lots within expiration date.
MANUFACTURER Solvay Pharmaceuticals, Inc., Baudette,
Minnesota.
RECALLED BY Solvay Pharmaceuticals, Inc., Marietta, Georgia
DISTRIBUTION Nationwide.
QUANTITY 1,814,103 units were distributed.
REASON Firm withdrawal of application (stability data).