JUNE 2002
WEEK ENDING JUNE 1
PRODUCT MAXAIR Inhaler With Oral Adapter (pirbuterol
acetate) 0.2 mg per actuation, 25.6g Inhalation Aerosol, 300 metered
inhalations, Rx only.
CODE
Lot
Numbers Expiration Date
000644 August
03
000756 August 03
000947 October 03
001009 Nov. 03
001110 Dec. 03
001111
Dec. 03
010025 Jan. 04
010195 March 04
010413 April 04
010283 March 04
010482 May
04
010580 June 04
010708 July 04
010709 July 04
010414 May 04
011210 Dec. 04
RECALLING FIRM/MANUFACTURER Recalling Firm: 3M Pharmaceuticals, Inc., St. Paul, MN
Manufacturer: 3M Pharmaceuticals, Inc., Northridge, CA.
REASON Defective container; inhaler may stick
intermittantly and patients may not receive the expected puff of medication.
VOLUME OF PRODUCT IN COMMERCE 737,975 inhalers.
DISTRIBUTION Nationwide.
PRODUCT Adriamycin PFS, (doxorubicin hydrochloride)
Injection USP, 150mg/75mL (2mg/mL), 75 mL Multidose Cytosafe Vial, Rx only;
Adriamycin
PFS, (doxorubicin hydrochloride) Injection, USP, 20mg/10mL (2mg/mL), 10 mL
Single dose Cytosafe Vial;
Adriamycin
PFS, (doxorubicin hydrochloride) Injection USP, 200mg/100mL (2mg/mL), 100 mL
Multidose Cytosafe Vial, Rx only;
Ellence,
(epirubicin hydrochloride) Injection, 200mg/100mL (2mg/mL), Single use 100 mL
Vial, Rx only;
Ellence,
(epirubicin hydrochloride) Injection, 50mg/25mL (2mg/mL), Single use 25 mL
Vial, Rx only;
Idamycin
PFS, (idarubicin hydrochloride) Injection, 10mg/10mL (1mg/mL), 10 mL Single dose
Cytosafe Vial, Rx only.
Idamycin
PFS, (idarubicin hydrochloride) Injection, 20mg/20mL (1mg/mL), 20 mL Single
dose Cytosafe Vial, Rx only.
Idamycin
PFS, (idarubicin hydrochloride) Injection, 5mg/5mL (1mg/mL), 5 mL Single dose
Cytosafe Vial, Rx only.
CODE a) Adriamycin PFS
1. Lot R945, Exp 02/03. 2. Lot
R944, Exp 02/03. 3. Lots R871 and
R910, Exp 02/03 and 02/03.
b)
Ellence 1. Lot R870, Exp 03/03. 2. Lot T079, Exp 04/03.
c)
Idamycin PFS 1. Lot R993, Exp
03/03. 2. Lot T021, Exp 03/03. 3. Lot T060, Exp 03/03.
RECALLING FIRM/MANUFACTURER Recalling Firm: Pharmacia
Corp., Kalamazoo, MI
Manufacturer:
Pharmacia (Perth) Pty Limited, Bentley, WA, 6102, Austrailia.
REASON Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE 57,580 units.
DISTRIBUTION United States and Puerto Rico.
PRODUCT Claforan Sterile (cefotaxime) for injection, USP
(formerly sterile cefotaxime sodium), 500 mg IM/IV, Vial, Rx only;
Claforan
Sterile (cefotaxime) for injection, USP (formerly sterile cefotaxime sodium), 1
gram IM/IV, Vial, Rx only;
Claforan
Sterile (cefotaxime) for injection, USP (formerly sterile cefotaxime sodium), 2
grams IM/IV, Vial, Rx only.
CODE 500-mg. x 10
Lot No. Exp. Date
100632 Oct-02
120416 Dec-02
120469 Dec-02
021969 Feb-03
051739 May-03
091877 Sep-03
1-gram
x 50 Lot No. Exp. Date
090668 Sep-02
090686 Sep-02
090688 Sep-02
110558 Nov-02
110565 Nov-02
110567 Nov-02
120421 Dec-02
120452 Dec-02
021912 Feb-03
021910 Feb-03
021914 Feb-03
021913 Feb-03
021911 Feb-03
031902 Mar-03
031903 Mar-03
041786 Apr-03
041829 Apr-03
041858 Apr-03
061704 Jun-03
091881 Sep-03
2-gram
x 10 Lot No. Exp. Date
090683 Sep-02
110551 Nov-02
041729 Apr-03
071840 Jul-03
101894 Oct-03
2-gram
x 25 Lot No. Exp. Date
110627 Nov-02
031947 Mar-03
041778 Apr-03
071839 Jul-03
2-gram
x 50 Lot No. Exp. Date
090679 Sep-02
110554 Nov-02
021948 Feb-03
041730 Apr-03
041791 Apr-03
041821 Apr-03
071838 Jul-03.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Pharmaceuticals, Inc., Kansas City,
MO
Manufacturer: Patheon UK Limited, Swindon, Wiltshire
SN35BZ, England.
REASON Labeling; product label declares inactive
ingredients that are not contained in the product (Dextrose Hydrous, USP,
Sodium Citrate Hydrous, USP and Hydrochloric Acid)
VOLUME OF PRODUCT IN COMMERCE 500-mg. - 418,200
vials; 1-gram - 1,635,450 vials; 2-gm. - 647,574 vials.
DISTRIBUTION Nationwide.
PRODUCT Q-Bid DM Sustained Release Tablet (Guaifenesin
600mg/Dextromethorphan 30mg), 100 tablet bottles, Rx only.
CODE Lot No. 005F1F.
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals,
Inc., Huntsville, AL
REASON Tablet mix-up; Q-Bid LA tablet containing the active
ingredient guaifenesin was found in a bottle of Q-Bid DM.
VOLUME OF PRODUCT IN COMMERCE 14,150 bottles of 100
tablets.
DISTRIBUTION Nationwide.
PRODUCT Ortho Micronor Oral Contraceptive Tablets
(norethindrone) 0.35 mg, 28 tablets in a ring-shaped blister pack, Rx only.
CODE Trade:
Lot 11M001 Exp. 11/04
Lot 11M002 Exp. 11/04
Lot 12C003 Exp. 01/05
Lot 12C004 Exp. 02/05
Physician
Samples: Lot 11M019 Exp. 11/04
Refills: Veridate
12A029 Exp. 01/05
12C030 Exp. 01/05.
RECALLING FIRM/MANUFACTURER Recalling Firm: Ortho-Mcneil
Pharmaceutical, Inc., Raritan, NJ
Manufacturer: Ortho-Mcneil Pharmaceutical Inc., Manati,
Puerto Rico.
REASON Mislabeling; labeling incorrectly informs user that
missing any pills 22-28 will still leave them protected.
VOLUME OF PRODUCT IN COMMERCE Trade -- 339,336
blisters; Veridate -- 40,320 blisters;
Samples -- 124,704.
DISTRIBUTION Nationwide.
PRODUCT a) Ziox Ointment (papain-urea-chlorophyllin copper
complex sodium) 30 gram tube, Rx only;
b) Kovia Ointment (papain-urea), 30 gram tube, Rx only; c) Nuquin HP 4% Gel
(hydroquinone USP, 4%), 1/2 oz and 1 oz tubes, Rx only.
CODE a) Lot #5075
Exp. 6/2003; b) Lot #5041 Exp. 6/2002; c) Lot #5015 Exp. 9/2002.
RECALLING FIRM/MANUFACTURER Sonar Products Inc.,
Carlstadt, NJ
REASON Subpotent: Ziox and Kovia Ointment for papain and
Nuquin 4% for padimate-o and dioxybenzone.
VOLUME OF PRODUCT IN COMMERCE a) 9,648 x 30g tubes; b)
51,201 x 30g tubes; c) 4,731 x 30g tubes, 2,537 x 15 g tubes.
DISTRIBUTION FL.
WEEK
ENDING JUNE 8
PRODUCT Doxorubicin Hydrochloride Injection, USP, 50mg/25mL
(2mg/mL), 25mL Single Dose Vial, Rx only.
CODE Lot T049 Exp. 9/2002.
RECALLING FIRM/MANUFACTURER Gensia Sicor
Pharmaceuticals, Inc., Irvine, CA
REASON Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE 20,520 vials.
DISTRIBUTION Nationwide.
PRODUCT Combivent Inhalation Aerosol (ipratropium bromide 18
mcg and albuterol sulfate 103 mcg) 14.7g canister, 200 metered actuations, Rx
only
CODE Lot Numbers:
165090A,
Exp. Date May-03
165092A,
Exp. Date May-03.
RECALLING FIRM/MANUFACTURER Boehringer Ingelheim
Pharmaceuticals, Inc., Ridgefield, CT
REASON Defective container; inhaler may not fire properly
and patients will not receive their full dose of medication.
VOLUME OF PRODUCT IN COMMERCE 192,089 units total.
DISTRIBUTION Nationwide.
PRODUCT Gyne-Lotrimin Vaginal Antifungal Cream 3-Day
Combination Pack (clotrimazole) 1%, vaginal inserts and 7 g (0.25 oz) tube,
over-the-counter.
CODE
Tube
Lot No. Combination Pack Lot No. Exp. Date
9KPE6 9CO513 09/30/2002
9KPE6 9CO514 09/30/2002
9KPE6 9CO512 09/30/2002
9KPE7 0CO501 09/30/2002
9KPE7 0CO502 09/30/2002
9KPE7 0CO500 09/30/2002
9KPE7 0CO503 09/30/2002
0KPE1 0CO504 01/30/2003
0KPE1 0CO505 01/30/2003
0KPE1 0CO506 01/30/2003
0KPE2 0CO507 04/30/2003
0KPE2 0CO508 04/30/2003
0KPE2 1CO500 04/30/2003
0KPE3 1CO501 08/30/2003
0KPE3 1CO503 08/30/2003
0KPE3 1CO505 08/30/2003
0KPE3 1CO504 08/30/2003
1KPE1 1CO506 01/30/2004.
RECALLING FIRM/MANUFACTURER Recalling Firm:
Schering-Plough HealthCare Products, Cleveland, TN
Manufacturer:
Schering Laboratories, Kenilworth, NJ.
REASON Degradation; specification failure (stability).
VOLUME OF PRODUCT IN COMMERCE 494,880 packages.
DISTRIBUTION Nationwide.
PRODUCT Rocaltrol (calcitriol) Oral Solution, 1 mcg/ml, 15
ml bottles, Rx only.
CODE Lot Number: U0005 exp. 2/2003.
RECALLING FIRM/MANUFACTURER Recalling Firm: Roche
Laboratories Nutley, NJ
Manufacturer:
Hoffmann La Roche, Nutley, NJ
REASON Subpotent; active ingredient calcitriol (18 month
stability).
VOLUME OF PRODUCT IN COMMERCE 5,692 bottles.
DISTRIBUTION Nationwide.
WEEK ENDING JUNE 15
PRODUCT Heparin Sodium Injection, USP, DERIVED FROM PORCINE
INTESTINES, 1000 units/mL, 1 mL DOSETTE Vials, 10 mL and 30 mL Multiple Dose
Vials, IV or SC use, Rx only.
Packaged
as: 25 x 1 mL DOSETTE Vials, 25 x 10 mL Multiple Dose Vials, and 25 x 30 mL
Multiple Dose Vials.
CODE All Lots.
RECALLING FIRM/MANUFACTURER Wyeth Ayerst/Elkin Sinn
Cherry Hill, NJ
REASON Particulates; clear crystals containing an
antioxidant compound from the vial rubber closures (stoppers).
VOLUME OF PRODUCT IN COMMERCE 0641-0391-25 -- 108,291 vials; 0641-2440-45 --
612,058 vials; 0641-2450-45 -- 1,168,878 vials.
DISTRIBUTION Nationwide and Costa Rica.
PRODUCT Lomotil tablets, Each tablet contains: diphenoxylate hydrochloride, USP 2.5 mg
atropine sulfate USP 0.025 mg, Rx only, bottles of 100, 1,000, 2,500, and unit
dose cartons of 100.
CODE Lot Numbers C200511 and C200682 in 100 tablet
bottles; Lot Numbers C200195 and C200577 in 1,000 tablet bottles; Lot
Number C200363 in 2,500 tablet bottles;
Lot Number C200360 in 100 tablet unit
dose carton.
RECALLING FIRM/MANUFACTURER Recalling Firm: Pharmacia
Corp., Kalamazoo, MI
REASON Tablets may contain metal particles.
VOLUME OF PRODUCT IN COMMERCE 9,720 bottles and cartons.
DISTRIBUTION Nationwide.
PRODUCT Levoxyl Tablets, 50 mcg, Each tablet contains
Levothyroxine Sodium 50 mcg, 100 tablet bottles, Rx only;
Levoxyl
Tablets, 100 mcg, Each tablet contains Levothyroxine Sodium 100 mcg, 30 and 100
tablet bottles, Rx only.
CODE 100 mcg, 30 tablet bottles 1243074, 1249173,
1250073, 1270231, 1275251, 1283185, 1297190
Product
code 5297-0; 100 mcg, 100 tablet bottles 1229122, 1234214, 1243125, 1253084,
1274147
Product
code 5297-1; 50 mcg, 100 tablet bottles
1270232, 1274149, 1275252, 1278114, 1282197
Product
code 5300-0.
RECALLING FIRM/MANUFACTURER Recalling Firm: Allscripts Healthcare Solutions,
Libertyville, IL
Manufacturer: King Pharmaceuticals, Inc. (formerly Daniels
Pharmaceuticals), St. Petersburg, FL
REASON Product from manufacturer lacks stability prior to
expiration date (subpotency and super potency).
VOLUME OF PRODUCT IN COMMERCE 13,820 - 100 mcg tablets,
18,600 - 50 mcg tablets.
DISTRIBUTION Nationwide.
PRODUCT Oxygen USP, compressed, held in high pressure
cylinders.
CODE Lot code: 010481/4.
RECALLING FIRM/MANUFACTURER Southern Welding Supply Co.,
Inc., Savannah, GA
REASON Good Manufacturing Practice (GMP's) Deviations
including, but not limited to, failure to test for purity and identity.
VOLUME OF PRODUCT IN COMMERCE 37.
DISTRIBUTION GA.
PRODUCT Premarin Tablets (conjugated estrogens tablets, USP)
0.625 mg,Rx Only.
Bottles
of 100
Bottles
of 1000
Bottles
of 5000
CODE
Lot
Numbers:
9001566,
exp. 07/03
9010254,
exp. 07/03
9010255,
exp. 07/03
EXPANDED
RECALL:
9010509,
exp. 10/03
9010510,
exp. 10/03.
RECALLING FIRM/MANUFACTURER Recalling Firm: Wyeth-Ayerst Laboratories, Richmond, VA
Manufacturer: Ayerst Laboratories, Inc., Rouses Point, NY.
REASON Failure to meet dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE 47,024 btls of 100; 9,255
btls of 1000; and 1,408 btls of 5000.
DISTRIBUTION Nationwide.
PRODUCT Lomotil Tablets (diphenoxylate hydrochloride, USP
2.5 mg and atropine sulfate, USP 0.025
mg), 100 tablets, Rx only.
CODE Lot Number: 021245, Exp. Date Apr 17 04.
RECALLING FIRM/MANUFACTURERRecalling Firm: AmeriSource Health Services Corp., Columbus,
OH
Manufacturer: G.D. Searle & Company, Chicago, IL.
REASON Tablets supplied by the manufacturer may contain
metal particles.
VOLUME OF PRODUCT IN COMMERCE 1,288 bottles of 100 tablets
each.
DISTRIBUTION Nationwide.
PRODUCT Calcijex, Calcitriol Injection, For I.V. use, 1
mcg/mL single dose ampul, Rx Only.
Recall # D-230-2.
CODE Lot No. 85-305-DK, Exp Date May 1, 2003 NDC
0074-8110-31
THIS
RECALL IS BEING EXTENDED ON MAY 16, 2002 TO INCLUDE ONE ADDITIONAL LOT:
Lot
No. 85-261-DK, Exp Date May 1, 2003 NDC 0074-8110-31.
RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Abbott Park, IL
Manufacturer: Abott Laboratories, Rocky Mount, NC.
REASON Mispackaging:
Vitamin K1 Injection found in a box of Calcijex injection.
VOLUME OF PRODUCT IN COMMERCE 126,075 units.
DISTRIBUTION Nationwide.
PRODUCT Various tablet, liquid and capsule dosage form drug
products, repackaged into bottles and unit dose blister packs of varying
sizes/counts,
labeled with brand or generic names, strength, lot number, expiration date,
National Drug Codes (NDC)and packager identified as TYA Pharmaceuticals
AGENERASE
Capsules 150 mg blister packs.
AMITRIPTYLINE
HCl Tablets 50 mg QTY 30/300.
*ASPIRIN
ENETERIC COATED 5 GR QTY 30/300.
CHLORPROMAZINE
Liquid 300 mg 3 mL bottles.
CLONIDINE
HCl Tablet 0.3 mg QTY 30/300.
DIPHENHYDRAMINE
Liquid 50 mg 20 mL bottles.
DIPHENHYDRAMINE
Liquid 75 mg 30 mL bottles.
DOXEPIN
Liquid 50 mg 5 mL bottles.
DOXEPIN
Liquid 100 mg 10 mL bottles.
DOXEPIN
Liquid 150 mg 15 mL bottles.
DOXEPIN
Liquid 200 mg 20 mL bottles.
ENALAPRIL
Tablets 10 mg QTY 30/400.
FLUPHENAZINE
Liquid 5 mg 1 mL bottles.
FLUPHENAZINE
Liquid 10 mg 2 mL bottles.
FLUPHENAZINE
Liquid 20 mg 4 mL bottles.
GLYBURIDE
Tablet 2.5 mg QTY 30/200.
HALOPERIDOL
Liquid 2 mg 1 mL bottles.
HALOPERIDOL
Liquid 5 mg 2.5 mL bottles.
HALOPERIDOL
Liquid 10 mg 5 mL bottles.
HALOPERIDOL
Liquid 15 mg 7.5 mL bottles.
HALOPERIDOL
Liquid 20 mg 10 mL bottles.
HIVID
Tablets .75 mg.
HYDROXYZINE
HCl Liquid 25 mg 12.5 mL bottles.
HYDROXYZINE
HCl Liquid 50 mg 25 mL bottles.
LITHIUM
CARBONATE Capsules 300 mg QTY 30/300.
LITHIUM
Liquid 300 mg 5 mL bottles.
LITHIUM
Liquid 450 mg 7.5 mL bottles.
LITHIUM
Liquid 600 mg 10 mL bottles.
LITHIUM
Liquid 1200 mg 20 mL bottles.
RANITIDINE
USP Tablets 150 mg QTY 30/300.
SUSTIVA
Capsules 200 mg blister packs.
THIORIDAZINE
Liquid 75 mg .75 mL bottles.
THIORIDAZINE
Liquid 100 mg 1 mL bottles.
THIORIDAZINE
Liquid 200 mg 2 mL bottles.
TRIAMTERENE
HCTZ Capsules 50/25 mg QTY 30/300.
VALPROIC
ACID Liquid 500 mg 10 mL bottles.
VALPROIC
ACID Liquid 1000 mg 20 mL bottles.
ZERIT
Capsules 30 mg blister packs.
ZERIT
Capsules 40 mg blister packs.
ZITHROMAX
Tablets 600 mg blister packs.
CHLORPROMAZINE
Liquid 100 mg 1 mL bottles.
*Enteric
is misspelled on product label.
CODE
AGENERASE
Capsules 150 mg blister packs--------Lot# 00382C
AMITRIPTYLINE
HCl Tablets 50 mg QTY 30/300-----Lot# 001081A
ASPIRIN
ENETERIC COATED 5 GR QTY 30/300--------Lot# 1539
CHLORPROMAZINE
Liquid 300 mg 3 mL bottles------Lot# 156294A
CLONIDINE
HCl Tablet 0.3 mg QTY 30/300---------Lot# 1J2840
DIPHENHYDRAMINE
Liquid 50 mg 20 mL bottles-----Lot# 2607A
DIPHENHYDRAMINE
Liquid 75 mg 30 mL bottles-----Lot# 2607A
DOXEPIN
Liquid 50 mg 5 mL bottles--------------Lot# 2678A
DOXEPIN
Liquid 100 mg 10 mL bottles------------Lot# 2678A
DOXEPIN
Liquid 150 mg 15 mL bottles------------Lot# 2678A
DOXEPIN
Liquid 200 mg 20 mL bottles------------Lot# 2678A
ENALAPRIL
Tablets 10 mg QTY 30/400-------------Lot# CHO0987, 1170205
FLUPHENAZINE
Liquid 5 mg 1 mL bottles----------Lot# MFC06
FLUPHENAZINE
Liquid 10 mg 2 mL bottles---------Lot# MFC06
FLUPHENAZINE
Liquid 20 mg 4 mL bottles---------Lot# MFC06
GLYBURIDE
Tablet 2.5 mg QTY 30/200-------------Lot# 124884A
HALOPERIDOL
Liquid 2 mg 1 mL bottles-----------Lot# 2505A, 2505D
HALOPERIDOL
Liquid 5 mg 2.5 mL bottles---------Lot# 2505A, 2505D
HALOPERIDOL
Liquid 10 mg 5 mL bottles----------Lot# 2505A, 2505D
HALOPERIDOL
Liquid 15 mg 7.5 mL bottles--------Lot# 2505A, 2505D
HALOPERIDOL
Liquid 20 mg 10 mL bottles---------Lot# 2505A, 2505D
HIVID .75mg-----------------------------------Lot#
47117A, 40558A
HYDROXYZINE
HCl Liquid 25 mg 12.5 mL bottles---Lot# 24303C
HYDROXYZINE
HCl Liquid 50 mg 25 mL bottles-----Lot# 24303C
LITHIUM
CARBONATE Capsules 300 mg QTY 30/300---Lot# 111077A
LITHIUM
CITRATE Liquid 300 mg 5 mL bottles-----Lot# 158273A, 158274A
LITHIUM
CITRATE Liquid 450 mg 7.5 mL bottles---Lot# 158273A, 158274A
LITHIUM
CITRATE Liquid 600 mg 10 mL bottles----Lot# 158273A, 158274A
LITHIUM
CITRATE Liquid 1200 mg 20 mL bottles---Lot# 158273A, 158274A
RANITIDINE
USP Tablets 150 mg QTY 30/300-------Lot# 00382C
SUSTIVA
Capsules 200 mg blister packs----------Lot# EPK347A, EPK372A, EPK373A
THIORIDAZINE
Liquid 75 mg .75 mL bottles-------Lot# 156303A
THIORIDAZINE
Liquid 100 mg 1 mL bottles--------Lot# 156303A
THIORIDAZINE
Liquid 200 mg 2 mL bottles--------Lot# 156303A
TRIAMTERENE
HCTZ Capsules 50/25 mg QTY 30/300--Lot# 101901A
VALPROIC
ACID Liquid 500 mg 10 mL bottles------Lot# 14010
VALPROIC
ACID Liquid 1000 mg 20 mL bottles-----Lot# 14010
ZERIT
Capsules 30 mg blister packs-------------Lot# 1C50244
ZERIT
Capsules 40 mg blister packs-------------Lot# 1G52495
ZITHROMAX
Tablets 600 mg blister packs---------Lot# 009K01E
CHLORPROMAZINE
Liquid 100 mg 1mL bottles-------Lot# 156294A.
RECALLING FIRM/MANUFACTURER TYA Pharmaceuticals,
Tallahassee, FL
REASON Labeled with incorrect expiration date.
VOLUME OF PRODUCT IN COMMERCE 277,750 doses.
DISTRIBUTION TX and FL.
State Health Director Announces That Antibiotic Found In Recalled Milk Is Penicillin
California
Department of Health Services (CDHS) Director Diana Bontα, R.N., Dr.P.H., warned
consumers today not to drink several milk products that have been voluntarily
recalled because they contain penicillin, an antibiotic that can cause severe
allergic reactions in some individuals. The California Department of Food and
Agriculture (CDFA) announced the recall of the milk products earlier today.
Individuals
with a history of penicillin reaction or multiple allergen sensitivity may
experience a severe life-threatening allergic condition called anaphylactic
shock within minutes to hours of exposure to penicillin. Symptoms of severe
allergic reactions include swelling of the throat and airway, and difficulty in
breathing. This condition requires emergency medical treatment
Alta
Dena is the latest brand added to the list of recalled milk products, which
includes Berkeley Farms, Dairy Dawn, Ralph's, Mountain Dairy, Sysco (Wholesome
Farms), Smart & Final, Albertson's, Good Day and Best Yet with the
"sell-by" dates listed below. These products were sold primarily in
retail stores, schools and other institutions from Monday morning, June 10,
through Thursday, June 13 in California and possibly in surrounding states.
Only
milk products with the plant codes of 06-407 or 6-21 and sell by dates of June
24, 25, 26, 27, 28, 29, and July 2 have been found to be contaminated with the
antibiotic. No illnesses or adverse reactions from these milk products have
been reported. CDFA, which detected the antibiotic contamination during routine
sampling, is leading the investigation to determine the source of the
contamination.
The manufacturer, Berkeley Farms of Hayward, initiated a voluntary recall of
these products after routine tests showed they may contain penicillin.
Antibiotic residues should not be in milk or milk products. Penicillin used to
treat infections in individuals can sometimes result in mild adverse effects or
allergic reactions, usually within 24 hours, such as rash, fever or diarrhea.
Individuals who have consumed the milk products and experience any of these
symptoms should consult their physician or health care provider.
Consumers
who have purchased these products should discard the milk or return it to the
place of purchase for a refund. Consumers with questions may contact Berkeley
Farms at 1-888-647-3326.
|
Product
Type |
Container
Sizes |
"Sell
by" Date |
|
Extra
Rich Milk |
Gallon |
June
24 |
|
Vitamin
D Milk |
Quart,
pint, ½ pint |
June
28 |
|
1%
Low Fat Buttermilk |
½
Gallon |
July
2 |
WEEK
ENDING JUNE 29
PRODUCT Tri-Nasal Nasal Spray (triamcinolone acetonide, USP)
50 mcg (0.05%), 120 metered sprays, 15mL bottles and professional samples, For
Intranasal Use Only, Rx Only.
CODE Product code: 5050-15 Retail 10605, 10705, 10805,
11006, 10807
Product
code: 5050-00 Professional Samples
10406,
10806, 10106, 10706, 10906, 10308, 10408, 10808, 10708, 10109, 10211, 10711,
10112.
RECALLING FIRM/MANUFACTURER Muro Pharmaceutical, Inc.,
Tewksbury, MA
REASON Subpotent;potency of the active ingredient
triamcinolone acetonide cannot be assured through labeled expiration date
VOLUME OF PRODUCT IN COMMERCE 377,742.
DISTRIBUTION Nationwide.
PRODUCT Tamiflu Capsules (oseltamivir phosphate),75mg, 10
capsule cartons and 15 x1 capsule Professional Samples, Rx only.
CODE Cartons of 10 Capsules
B1022-01,
exp. 6/02
B1023-01,
exp. 6/02
B1024-01,
exp. 6/02
B1025-01,
exp. 6/02
B1029,
exp. 9/02
B1029-01,
exp. 9/02
B1025-02,
exp. 6/02
Physician
Samples (15s)
B1025-03,
exp. 6/02.
RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Laboratories, Nutley, NJ
Manufacturer: F. Hoffmann - La Roche, AG CH-4070 Basel,
Switzerland.
REASON Potential cross contamination with active
ingredients which could include mefloquine, levodopa/benserazide, and/or
sulfamethoxazole.
VOLUME OF PRODUCT IN COMMERCE 1,021,141 trade lots; 1,800
free goods; 153,264 physician samples.
DISTRIBUTION Nationwide.