DECEMBER 2001
WEEK
ENDING DECEMBER 8
PRODUCT Equate Allergy Medication Decongestant Caplets in 24
caplet blister cartons. The product is an OTC product containing
Diphenhydramine Hydrochloride 25 mg and Pseudoephedrine Hydrochloride 60 mg., Capsule-Shaped
tablets
CODE Lot No. 1GB0825, 1GB1041, 1GB1042.
RECALLING FIRM/MANUFACTURER Recalling Firm: Leiner
Health Products, Inc. Carson, CA.
Manufacturer:
Leiner Health Products, Inc. Fort Mill, SC.
REASON Misbranding; directions for use may lead to a
doubling of the dosage.
VOLUME OF PRODUCT IN COMMERCE 45,504/24 caplet cartons.
DISTRIBUTION Nationwide.
PRODUCT Tiratricol, bulk powder, in 250 gram or 1000 gram
containers,
CODE All lots.
RECALLING FIRM/MANUFACTURER Recalling Firm: Integrity
Chemicals International, Sarasota, FL
Manufacturer:
Unknown. Importer: Tolbiac S.R.L., Buenos Aires, Argentina.
REASON Unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE 1750 grams.
DISTRIBUTION CA and MN.
PRODUCT T3 Pro-Thyroid Technology, 90 capsules, Tiratricol,
1000 mcg, Product was packaged 12 bottles to a case.
CODE All codes are recalled.
RECALLING FIRM/MANUFACTURER Recalling Firm: Global
Enterprises College Station, TX
Manufacturer:
Golden Desert Manufacturing Phoenix, AZ.
REASON Unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE 8253 bottles of 90.
DISTRIBUTION TX.
PRODUCT BIOPHARM T-Cuts Capsules, Trycan 100 mgs
(pharmaceutical grade Tiratricol), 90 count bottles
CODE Lot #2276 exp. 6/03.
RECALLING FIRM/MANUFACTURER Recalling Firm: ATF Fitness
Products, Inc., Oakmont, PA
Manufacturer:
GDM, Inc Phoenix, AZ.
REASON Unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE 400 units.
DISTRIBUTION CA, VA, WV, NM, IN, SC, WA, NC, LA and
Canada.
PRODUCT Equate Allergy Medication Decongestant Caplets in 24
caplet blister cartons. The product
contains Diphenhydramine Hydrochloride 25 mg and Pseudoephedrine Hydrochloride
60 mg
CODE Lot No. 1GB0825, 1GB1041, 1GB1042.
RECALLING FIRM/MANUFACTURER Recalling Firm: Leiner
Health Products, Inc., Carson, CA
Manufacturer:
Leiner Health Products, Inc., Fort Mill, SC.
REASON Misbranding; directions for use may lead to a
doubling of the dosage.
VOLUME OF PRODUCT IN COMMERCE 45,504/24 caplet cartons.
DISTRIBUTION Nationwide.
PRODUCT Rescriptor 200 mg tablets (delavirdine mesylate
tablets), NDC 0009-7576-01, Bottles of 180 tablets
CODE Lot no. 17DSJ
Exp. date 11/01.
RECALLING FIRM/MANUFACTURER Recalling Firm: Pfizer Inc.,
New York, NY
Manufacturer:
Pharmacai & UpJohn Barceloneta,
Puerto Rico.
REASON Lowered therapeutic effectiveness.
VOLUME OF PRODUCT IN COMMERCE 1,949 bottles.
DISTRIBUTION Nationwide.
PRODUCT Meperidine HCL Injection, USP, 25,50,75 and 100
mg/mL-1 mL Dosette vials.
Wyeth
Ayerst, ESI Lederle, Labeled Products:
Meperidine
HCl Injection, USP 25 mg/ml, 25 x 1 mL DOSETTE vial;
Meperidine
HCl Injection, USP 50 mg/ml, 25 x 1 mL DOSETTE vial;
Meperidine
HCl Injection, USP 75 mg/ml, 25 x 1 mL DOSETTE vial;
Meperidine
HCl Injection, USP 100 mg/ml, 25 x 1 mL DOSETTE vial.
Labeled
Products:
Meperidine
HCl Injection, USP 25 mg/ml, 25 x 1 mL DOSETTE vial;
Meperidine
HCl Injection, USP 50 mg/ml, 25 x 1 mL DOSETTE vial;
Meperidine
HCl Injection, USP 75 mg/ml, 25 x 1 mL DOSETTE vial;
Meperidine
HCl Injection, USP 100 mg/ml, 25 x 1 mL DOSETTE vial.
CODES: All lots (Baxter, ESI Lederle labels) within
expiry of Mepridine HCL Injection, 25mg/ml, 50mg/ml, 75mg/ml, 100mg/ml.
ESI
Lots: 25 mg/mL:
Lot
010095 EXP 10/01;
Lot
010127 EXP 10/01;
Lot
030093 EXP 12/01;
Lot
030097 EXP 12/01;
Lot
040048 EXP 1/02;
Lot
110135 EXP 8/02;
Lot
021175 EXP 11/02;
Lot
041010 EXP 1/03;
Lot
051087 EXP 2/03;
Lot
081004 EXP 5/03;
Lot
071173 EXP 4/03;
Lot
040106 EXP 1/02;
Lot
110065 EXP 8/02;
Lot
071125 EXP 4/03;
Lot
060032 EXP 3/02;
Lot
010151 EXP 10/01.
50 mg/mL:
Lot
010053 EXP 10/01;
Lot
010061 EXP 10/02;
Lot
020119 EXP 11/01;
Lot
030090 EXP 12/01;
Lot
030099 EXP 12/01;
Lot
030185 EXP 12/01;
Lot
030083 EXP 12/01;
Lot
050148 EXP 2/02;
Lot
050112 EXP 2/02;
Lot
040050 EXP 1/02;
Lot
040035 EXP 1/02;
Lot
070072 EXP 4/02;
Lot
110110 EXP 8/02;
Lot
120066 EXP 9/02;
Lot
050142 EXP 2/02;
Lot
021073 EXP 11/02;
Lot
031112 EXP12/02;
Lot
051089 EXP 2/03;
Lot
041167 EXP 1/03;
Lot
041131 EXP 1/03.
75 mg/mL:
Lot
031087 EXP 9/02;
Lot
050014 EXP 11/01;
Lot
050017 EXP 11/01;
Lot
090093 EXP 3/02;
Lot
061009 EXP 12/02;
Lot
071160 EXP 1/03.
100 mg/mL:
Lot
051074 EXP 11/02;
Lot
040149 EXP 10/01;
Lot
060136 EXP 12/02;
Lot
100061 EXP 4/02;
Lot
100063 EXP 4/02;
Lot
110004 EXP 5/02;
Lot
021080 EXP 8/02;
Lot
051018 EXP 11/02;
Lot
081137 EXP 2/03.
Baxter
Lots:
25 mg/mL:
Lot
040103 EXP 1/02;
Lot
060038 EXP 3/02;
Lot
080115 EXP 5/02;
Lot
031114 EXP 12/02;
Lot
081167 EXP 5/03.
50 mg/mL:
Lot
020116 EXP 11/01;
Lot
030088 EXP 12/01;
Lot
040159 EXP 1/02;
Lot
060085 EXP 3/02;
Lot
060040 EXP 3/02;
Lot
060087 EXP 3/02;
Lot
070125 EXP 4/02;
Lot
080075 EXP 5/02;
Lot
080137 EXP 5/02;
Lot
090147 EXP 6/02;
Lot
090057 EXP 6/02;
Lot
110107 EXP 8/02;
Lot
011064 EXP 10/02;
Lot
021078 EXP11/02;
Lot
031079 EXP 12/02;
Lot
051076 EXP 2/03;
Lot
041002 EXP 1/03;
Lot
041014 EXP 1/03;
Lot
051132 EXP 2/03.
75 mg/Ml
Lot
080077 EXP 2/02;
Lot
031093 EXP 9/02.
100 mg/mL:
Lot
080182 EXP 2/02.
RECALLING FIRM/MANUFACTURER Wyeth Ayerst ESI Lederle,
Cherry Hill, NJ
REASON Particulates (clear crystals).
VOLUME OF PRODUCT IN COMMERCE 581,240 packs.
DISTRIBUTION Nationwide.
Aloe
Flex Enterprises of Dickinson, Texas is recalling all lots of its 1 ounce
bottles of "Weider's Eyedrops" due to potentially serious health
risks associated with bacterial contamination. Samples analyzed by the Food and
Drug Administration were found to contain bacteria including Acinetobacter
calcoaceticus-baumannii, which in some cases can cause sight-threatening
injury.
The
product is labeled "Weider's Eyedrops" with the company name of
"Flex Enterprises". Some lots of the product have also been marketed
under the a second brand name, "Welder's Eyedrops". The recalled
"Weider's Eyedrops" and "Welder's Eyedrops" were sold
over-the-counter in Dickinson, Texas.
To
date, there have been no reports of injury in connection with these products.
Individuals who have used these products and have experienced any adverse
reactions are advised to contact their healthcare provider.
Consumers who have purchased "Weider's Eyedrops" or "Welder's Eyedrops" are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 281-337-2240.
PRODUCT Cortisporin Ointment (neomycin and polymyxin B
sulfates, bactracin zinc, and hydrocortisone ointment, USP), Rx, ½ ounce
tube
CODE MK10/8899, EXP June 2004.
RECALLING FIRM/MANUFACTURER King Pharmaceuticals, Inc.,
Bristol, TN
REASON Subpotent for Polymycin B Sulfate component
(Stability 28-month test point).
VOLUME OF PRODUCT IN COMMERCE 38,481 units
DISTRIBUTION
Nationwide
PRODUCT Cardiolite (kit for the preparation of technetium
Tc99m Sestamibi for injection), 5ml vial packaged in a 5 vial kit
CODE Lot Number 3749; Exp. 1 Apr ‘03
RECALLING FIRM/MANUFACTURER Ben Venue Laboratories,
Inc., Bedford, OH
REASON Lack of assurance of sterility (Vial seal integrity)
VOLUME OF PRODUCT IN COMMERCE 3,543 kits (5-vial kits)
DISTRIBUTION Nationwide, Aman, Guam
PRODUCT a. Pangestyme Capsules (Ethex brand) UL12
Pancrelipase Enteric Coated Microtablets Contained in a Capsule, each capsule
contains 12,000 USP units lipase, 39,000 USP units amylase, and 39,000 USP
units protease, packaged in 12-capsule bottles, NDC #58177-048-10, and
100-capsule bottles.
b.
Pangestyme Capsules (ETHEX brand) UL18 Pancrelipase Enteric Coated Microtablets
Contained in a Capsule, each capsule contains
18,000
USP units lipase, 58,500 USP units amylase, and 58,500 USP units protease,
packaged in 100-capsule bottles only.
c.
Pangestyme Capsules (ETHEX brand) UL20 Pancrelipase Enteric Coated Microtablets
Contained in a Capsule, each capsule contains
20,000
USP units lipase, 65,000 USP units amylase, and 65,000 USP units protease,
packaged in 100-capsule bottles only.
d.
Pangestyme Capsules (Ethex brand) MT16 Pancrelipase Enteric Coated Microtablets
Contained in a Capsule, each capsule contains
16,000
USP units lipase, 48,000 USP units amylase and 48,000 USP units protease,
packaged in 100-capsule bottles only.
e.
Pangestyme Capsules (ETHEX brand) EC Pancrelipase Enteric Coated Microspheres
Contained in Capsules, each dye-free capsule contains 4,500 USP units lipase,
20,000 USP units amylase, and 25,000 USP units protease, packaged in 12-, 100-,
and 250-capsule bottles,
10
(12's), only.
All
bottles are labeled as Manufactured by KV Pharmaceutical Co. for ETHEX Corporation,
St. Louis, MO.
CODES:
a. Pangestyme UL12
Lot 28462, Exp. 04/02
Lot 28463, Exp. 04/02
Lot 32515, Exp. 11/02
b. Pangestyme UL18
Lot 28465, Exp.04/02
Lot 28466, Exp. 06/02
Lot 28467, Exp. 06/02
Lot 29888, Exp. 06/02
c. Pangestyme UL20
Lot 28642, Exp. 04/02
Lot 28643, Exp. 06/02
Lot 28653, Exp. 06/02
Lot 29930, Exp. 06/02
Lot 29931, Exp. 06/02
Lot 29932, Exp. 06/02
d. Pangestyme MT16
Lot 27478, Exp. 03/02
Lot 27479, Exp. 03/02
Lot 27480, Exp. 03/02
Lot 28639, Exp. 04/02
Lot 28640, Exp. 04/02
Lot 28641, Exp. 05/02
Lot 30245, Exp. 04/02
e. Pangestyme EC
Lot 27487, Exp. 05/02
Lot 27488, Exp. 05/02
Lot 27489 (250-ct.), Exp. 05/02
Lot 27777, Exp. 06/02
Lot
27778, Exp. 07/02
Lot 27779 (250-ct.), Exp. 07/02
Lot 27780 (250-ct.), Exp. 08/02
Lot 30882, Exp. 07/02
Lot 30883, Exp. 07/02
Lot 30934, Exp. 07/02
RECALLING FIRM/MANUFACTURER Manufacturer: KV
Pharmaceutical Co. St. Louis, MO
Recalling
Firm: ETHEX Corporation St. Louis, MO
REASON: Subpotency
(Stability)
VOLUME OF PRODUCT IN COMMERCE a) UL12 - 4,581 btls; b)UL18
- 3,474 btls; c)MT16 - 9,016 btls; d) UL20 - 6,462 btls; e) EC - 22,723 btls
DISTRIBUTION Nationwide
PRODUCT Dipyridamole Injection, 50 mg/10 mL (5 mg/mL), 10 mL
fill in 10 mL, Flint Tubing single dose vial
CODE Lot 110632, Exp. April 2002
RECALLING FIRM/MANUFACTURER American Pharmaceutical
Partners, Inc., Melrose Park, IL
REASON Specification failure in impurities testing.
VOLUME OF PRODUCT IN COMMERCE 20,130 vials
DISTRIBUTION Nationwide
WEEK ENDING DECEMBER 29
Aloe Flex Enterprises Announces Recall of "Weider's Eyedrops"
Aloe Flex Enterprises of Dickinson, Texas is
recalling all lots of its 1 ounce bottles of "Weider's Eyedrops" due
to potentially serious health risks associated with bacterial contamination.
Samples analyzed by the Food and Drug Administration were found to contain
bacteria including Acinetobacter calcoaceticus-baumannii, which in some cases
can cause sight-threatening injury.
The product is labeled "Weider's Eyedrops"
with the company name of "Flex Enterprises". Some lots of the product
have also been marketed under the a second brand name, "Welder's
Eyedrops". The recalled "Weider's Eyedrops" and "Welder's
Eyedrops" were sold over-the-counter in Dickinson, Texas.
To date, there have been no reports of injury in
connection with these products. Individuals who have used these products and
have experienced any adverse reactions are advised to contact their healthcare
provider. Consumers who have purchased "Weider's Eyedrops" or "Welder's
Eyedrops" are urged to return them to the place of purchase for a full
refund. Consumers with questions may contact the company at 281-337-2240.