AUGUST 2001
WEEK ENDING AUGUST 4
PRODUCT AND CODE: ECO DENT ULTIMATE NATURAL
DAILY RINSE, Tangy Orange-Clove,labeled in part,"ECO-DENT***PREMIUM ORAL
CARE PRODUCTS***Tangy Orange-Clove Ultimate Essential MouthCare Natural Daily
Rinse***Mer- flu-an*** 8 fl. oz/237 ml** CODE: Lots 9431, 0002, 0376.
REASON: BACTERIA CONTAMINATION; Pseudomonas alcaligenes
& Pseudomonas baleurica
MANUFACTURER/RECALLING FIRM: TRUETT LABORATORIES, INC.,
CA
DISTRIBUTION: AR, AZ, CA, CO, FL, IA, IN, NH, NJ, NY, OH,
OR, TX, VT, WI AND INTERNATIONALLY TO CANADA AND AUSTRALIA
QUANTITY: 14,209 8 oz bottles
FDA
today announced that Bayer Pharmaceutical Division is voluntarily
withdrawing Baycol (cerivastatin) from the U.S. market because of reports of
sometimes fatal rhabdomyolysis, a severe muscle adverse reaction from this
cholesterol-lowering (lipid-lowering) product. The FDA agrees with and supports
this decision.
Baycol
(cerivastatin), which was initially approved in the U.S. in 1997, is a member
of a class of cholesterol lowering drugs that are commonly referred to as
"statins." Statins lower cholesterol levels by blocking a specific
enzyme in the body that is involved in the synthesis of cholesterol. While all
statins have been associated with very rare reports of rhabdomyolysis, cases of
fatal rhabdomyolysis in association with the use of Baycol have been reported
significantly more frequently than for other approved statins.
Fatal
rhabdomyolysis reports with Baycol have been reported most frequently when used
at higher doses, when used in elderly patients, and particularly, when used in
combination with gemfibrozil (LOPID and generics), another lipid lowering drug.
FDA has received reports of 31 U.S. deaths due to severe rhabdomyolysis associated
with use of Baycol, 12 of which involved concomitant gemfibrozil use.
Rhabdomyolysis
is a condition that results in muscle cell breakdown and release of the
contents of muscle cells into the bloodstream. Symptoms of rhabdomyolysis
include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea,
and vomiting. The pain may involve specific groups of muscles or may be
generalized throughout the body.
Most
frequently the involved muscle groups are the calves and lower back; however,
some patients report no symptoms of muscle injury. In rare cases the muscle
injury is so severe that patients develop renal failure and other organ
failure, which can be fatal.
Bayer
Pharmaceutical Division has announced plans to recall Baycol to the pharmacy
level. Pharmacies will be instructed to return the product to the manufacturer
for a refund. Patients who are taking Baycol should consult with their
physicians about switching to alternate medications to control their
cholesterol levels. Patients taking Baycol who are experiencing muscle pain or
are also taking gemfibrozil should discontinue Baycol immediately and consult
their physician.
There
are five other statins available in the U.S. that may be considered as
alternatives to Baycol. They are: lovastatin (Mevacor), pravastatin
(Pravachol), simvastatin (Zocor), fluvastatin (Lescol), and atorvastatin
(Lipitor).
For
further information regarding the withdrawal of Baycol, patients and physicians
can contact Bayer Customer Service 1-800-758-9794 or the FDA's Drug Information
Office at 301-827-4573 or 1-888-INFO-FDA, or go to "Baycol
Information" on FDA's Website.
PRODUCT AND CODE: Chloroquine Phosphate Bulk
Powder, for compounding,in bottles labeled as containing 5, 25, 100, or 500
grams per bottle. The bottles are also
labeled as packaged by Universal Chemical, St. Peter, MN Code: Lot UC99020502, Packaged 02/99, CAS 50-63-5
REASON: MIX-UP; BOTTLES LABELED TO CONTAIN CHLOROQUINE
PHOSPHATE POWDER WERE FOUND TO CONTAIN CLONIDINE , AN ANTI-HYPERTENSIVE DRUG
MANUFACTURER/RECALLING FIRM: China North Industries
Nanjing Corporation, Nanjing, China,
RECALLED BY: Hawkins Chemical, Inc., Minneapolis, MN
DISTRIBUTION: AZ, CA, FL, LA, MN, OR, SC, TN, UT
QUANTITY: The following numbers of bottles of chloroquine
phosphate, having lot number UC99020502, were shipped: four 5-gram bottles;
twenty 25-gram bottles; twenty 100-gram bottles; and five 500-gram bottles.
Perrigo
Company
today announced that, in cooperation with the U.S. Food and Drug Administration
(FDA), it is conducting a recall of 7,788 four-ounce bottles of cherry-flavored
pain reliever suspension liquid with Lot Number 1AD0228.
Perrigo
determined that this lot may contain an excess of up to 29 percent over the
labeled amount of acetaminophen. The product is being recalled because
overdoses of acetaminophen can lead to severe health problems including liver
toxicity and liver failure.
The
product, which is used to treat headaches and fevers in children, was sold
under the Good Sense® label at various small independent retail chains across
the country, under the Hy-Vee® label at Hy-Vee stores in Illinois, Iowa,
Kansas, Minnesota, Missouri, Nebraska and South Dakota and under the Kroger®
label at Kroger stores in Alabama, Arkansas, Georgia, Illinois, Indiana,
Kentucky, Louisiana, Michigan, Mississippi, Missouri, North Carolina, Ohio,
South Carolina, Tennessee, Texas, Virginia and West Virginia.
Perrigo
immediately notified the FDA as well as the retailers and wholesale
distributors of this product. No consumer complaints have been reported. Of the
7,788 bottles affected in this recall, Perrigo estimates that approximately
6,500 were purchased by consumers. The rest have been removed from retailers’
shelves and inventory.
Consumers
who purchased bottles with Lot Number 1AD0228, which is printed on each
bottle’s label and carton, are urged to discontinue use of the product
immediately and return it to the place of purchase for a full refund. Consumers
with questions may contact Perrigo at 1-800-321-0105.
WEEK ENDING AUGUST 25
PRODUCT AND CODE: Nutrapin AQ [somatropin
(rDNA origin) injection] 5mg/ml (2ml/vial), 10 mg per vial.
CODE:
Lot L9504A3 Exp. Dec 2001 Lot L9504A2 Exp. Apr 2002
REASON: Counterfeit
MANUFACTURER/RECALLING FIRM: Unknown
RECALLED BY: Mediq, Pennsauken, NJ
DISTRIBUTION: CA and GA
QUANTITY: 195 cases x 6 unit vials per carton = 1170 unit
vials
PRODUCT AND CODE: 1. Regular strength liquid
antacid packaged in 1-gal. jugs and 12-fl. oz. bottles, each 5-ml. tsp.
contains 200-mg. aluminum hydroxide (equiv. to dried gel, USP), 200-mg.
magnesium hydroxide, and 20-mg. simethicone. Product is packaged and
distributed in the 12-fl. oz. size under the following labels and sizes:
a. York Antacid Liquid with Simethicone Antacid
- Anti-Gas Original Flavor, 1-gal. container, Lot 0006052. The responsible firm on the label shows the
product is manufactured by York Pharmaceuticals, Inc., Kansas City, KS.
b. ShurFine Fast Acting Antacid Anti-Gas
Original, 12-fl. oz. bottles, Lot 0003018.
Distributed by Shurfine International, Inc., Northlake, IL.
c. Dollar General Regular Strength Fast Acting
Antacid Liquid Antigas/Antacid Original, 12-fl. oz. bottles, Lot 0006052. Distributed
By
Dolgencorp, Inc., Scottsville, KY.
d. Smart Choice Liquid Antacid Plus
Simethicone, 12-fl. oz. bottles, Lot 0006052.
Distributed by National Distribution Network, Merrick, NY.
2.
Maximum strength liquid antacid packaged in 1-gal. jugs and 12-fl. oz. bottles,
each 5-ml. tsp. contains 400-mg. aluminum hydroxide
(equiv.
to dried gel, USP), 400-mg. magnesium hydroxide, and 40-mg. simethicone,
indicated for use in heartburn, acid indigestion, sour
stomach,
associated symptoms of gas and upset stomach, overindulgence in food and drink.
a. York Extra Strength Antacid Suspension with
Simethicone Antacid - Anti-Gas Original Flavor, 1-gal. jug, Lot 0006092.
Manufactured by York Pharmaceuticals, Inc., Kansas City, KS.
b. Rite Aid Fast Acting Antacid & Anti-gas
Maximum Strength Original, 12-fl. oz. bottles, Lot 0003048. Distributed by Rite
Aid
Corporation,
Harrisburg, PA.
c. Select Brand Maximum Strength Fast Acting
Antacid Anti-Gas Original, 12-fl. oz. bottles, Lot 0006092. Distributed by Select Brand
Distributing,
Pine Bluff, AR.
d. Discount Drug Mart Food Fair Maximum
Strength Fast Acting Antacid Liquid Original Flavor, 12-fl. oz. bottles, Lot
0006092. Distributed by Drug Mart-Food Fair, Medina, OH.
CODE:
Lot 0003018, exp. 3/02
Lot 0003048, exp. 3/02
Lot 0006052, exp. 6/02
Lot 0006092, exp. 6/02
REASON: TOTAL AEROBIC MICROBIAL COUNT FAILURES AND LACK OF
PRESERVATIVE EFFECTIVENESS TESTING
MANUFACTURER/RECALLING FIRM: York Pharmaceuticals,
Inc., Kansas City, KS
DISTRIBUTION: OK, MS, MO, MD, CA, OR, AR, ND, NY, and OH
QUANTITY: The following approx. amounts were dist: Lot
0003018 - 965/12/12-fl. oz. btl cs; Lot 0003048 - 260/12/12-fl. oz. btl cs; lot
0006052 -
1,826/12/12-fl.
oz. btl cs and 135/4/1-gal. jug cs; lot 0006092 - 502/12/12-fl. oz. btl cs and
132/4/1-gal jug cs
RECALL NUMBER, PRODUCT AND CODE: 1) ALUPENT (metaproterenol
sulfate USP) Inhalation Solution, 0.4% (10mg/vial)
2)
ALUPENT (metaproterenol sulfate USP) Inhalation Solution, 0.6% (15mg/vial); The
manufacturer's brand name product is packaged in 25
X
2.5 ml Unit-Dose Vials, under the Boegringer Ingelheim label,
3)
D-286-1, METAPROTERENOL Sulfate Inhalation Solution USP, 0.6% (15mg/vial); The
generic brand name product is packaged in 25 X 2.5
ml
Unit-Dose Vials, under the Roxane Laboratories label
CODE:
ALUPENT 0.4%:
Lot
Number Exp Date
057144 Jul-02
780508 May-02
780507 Apr-02
780506 Mar-02
780505 Feb-02
780503 Dec-01
780502 Oct-01
ALUPENT
0.6%:
Lot
Number Exp Date
690552 Nov-02
690551 Aug-02
699554 Oct-01
METAPROTERENOL
SULFATE USP 0.6%:
Lot
Number Exp Date
992862 Oct-01
REASON:
LACK
OF ASSURANCE OF STERILITY (CGMP DEVIATIONS)
MANUFACTURER/RECALLING FIRM: ROXANE LABORATORIES, INC.,
Columbus, OH. This firm is part of the
Boehringer Ingelheim Corporation
DISTRIBUTION: OH, KY, AZ, CA, MA, MO, OR, FL, MA, NJ, MN,
PA, AL, TX, CO, CT, ID, IL, LA, MS, NY, NC, SC, TN, UT, VA, WA, AK, WI, HI, and
NM.
QUANTITY: 26,506 boxes / 25 vials each
PRODUCT AND CODE: Diflucan Tablets, 100 mg
(Fluconazole Tablets), 30 Tablets
CODE:
Lot 04P016A, Exp 11/02
REASON: COUNTERFEIT
MANUFACTURER/RECALLING FIRM: Unknown
RECALLED BY: Rebel Distributors Corp., Westlake Village,
CA
DISTRIBUTION: CA
QUANTITY: 7 bottles
PRODUCT AND CODE: (Rx) Dynabac tablets,
delayed release (Dirithromycin) 250 mg, 10 and 60 count, eight various lots
REASON: Related substance test failure at stability (12
Month)
MANUFACTURER/RECALLING FIRM: Eli Lilly and Company,
Indianapolis, IN
DISTRIBUTION: Nationwide
QUANTITY: 52,060 ñ60ís
137,832-10ís
PRODUCT AND CODE: White with Blue Specks.
The product is sold in 100 count and 500 count bottles. The label states that
the product is manufactured for: Pittsburgh Pill Emporium, Pittsburgh, PA or
Casey's Distributors, Williamsport, PA. The Casey labeled product is only for
the 100 count size. The Pittsburgh Pill labeled product is for both the 100 and
500 count sizes. CODE: Lot #6076 exp. 2/02
REASON: STABILITY: THERE IS NO DATA TO SUPPORT LABELED
EXPIRY DATE
MANUFACTURER/RECALLING FIRM: Nittany Pharmaceuticals,
Inc., Milroy, PA
DISTRIBUTION: PA
QUANTITY: 142 bottles
PRODUCT AND CODE: Yellow Rockets Tablets,
200 mg Caffeine. The product is sold in 100 count, 250 count, and 500 count
bottles. CODE: Lot 10293 exp. 2/03
REASON: STABILITY: THERE IS NO DATA TO SUPPORT LABELED
EXPIRY DATE
MANUFACTURER/RECALLING FIRM: Nittany Pharmaceuticals,
Inc., Milroy, PA
DISTRIBUTION: IA
QUANTITY: 1083 bottles
PRODUCT AND CODE: Perphenazine Tablets,USP,
2mg, 4mg, 8mg, and 16mg Strengths, packaged in 100 and 500 bottles.
Perphenazine
Tablets,USP, 2mg
Perphenazine
Tablets,USP, 4 mg
Perphenazine
Tablets,USP, 8 mg
Perphenazine
Tablets,USP, 16 mg
CODE:
Perphenazine Tablets, 2 mg, 4 mg, 8mg, and 16mg strengths:
Lot
Numbers: 2mg: 3667-103; 3667-105; 3667-106; 3667-107; 3667-108, 3667-109
4mg:
3668-153; 3668-154; 3668-155; 3668-156; 3668-157; 3668-158; 3668-159; 3668-160;
3668-161
8mg:
3669-232; 3669-233; 3669-234; 3669-235; 3669-236; 3669-237; 3669-238; 3669-239;
3669-240; 3669-241; 3669-242; 3669-243; 3669-244; 3669-
245;
3669-246; 3669-247
16mg:
3670-081; 3670-082; 3670-083; 3670-084
REASON: TABLET DISCOLORATION
MANUFACTURER/RECALLING FIRM: Zenith Goldline
Pharmaceuticals, Northvale, NJ
DISTRIBUTION: Nationwide
QUANTITY: 2mg=12,000,000 tablets; 4mg=18,000,000 tablets,
8mg=16,000,000 tablets, 16mg=4,000,000 tablets
PRODUCT AND CODE: Cortizone 10 Plus (1%
hydrocortisone) CrËme, 1 and 2 ounce tubes
CODE:
3 lots involved:
2 oz --- 2400453, exp. 7/2002
1 oz --- 2400452, exp. 7/2002
1 oz --- 2400470, exp. 7/2002
REASON: CONTAMINATION: PRODUCT IS CROSS-CONTAMINATED WITH
THE FIRMíS BEN-GAY PRODUCT (METHYL SALICYLATE, MENTHOL, AND CAMPHOR)
MANUFACTURER: PFIZER, INC., PARSIPPANY, NJ
RECALLED BY: Warner Lambert Consumer Health Care/Pfizer,
Inc., Morris Plains, NJ
DISTRIBUTION: Nationwide
QUANTITY: 441,336 tubes