FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
06/07/1995
ENFORCEMENT REPORT FOR 06/07/95
June 7, 1995 95-23
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Aunt Jemima Original Syrup, made with 5% Real Maple Syrup.
Recall #F-666-5.
CODE Bottle code: 4GM14K, 4GM15K;
Case Code: NOV 14 94 GM, NOV 15 94 GM
MANUFACTURER E.D. Smith-Gem, Inc., Byhalia, Mississippi.
RECALLED BY The Quaker Oats Company, Chicago, Illinois, by telephone and
fax May 5, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Georgia, New Jersey, Texas, Oklahoma, Tennessee.
QUANTITY 2,474 cases (9 bottles per case) were distributed; firm
estimated that 50 percent of product remained on market at
time of recall initiation.
REASON Yeast contamination.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Indomethacin Extended Release Capsules USP 75 mg, Rx anti-
inflammatory. Product lot 4D016 was packaged, labeled and
distributed for a single customer bearing customer label.
Lots 4C017 and 4C139 were distributed under the Inwood and 7
different customer labels: Rugby, Major, H.L. Moore, Parmed,
Schein, Lemmon, Goldline, United Research and Geneva.
Recall #D-176-5.
CODE Lot numbers: 4C017, 4C139, 4D016, EXP 11/95.
MANUFACTURER Inwood Laboratories, Inwood, New York.
RECALLED BY Manufacturer, by letter May 3, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 16,536 60-capsule bottles of lot 4C139; 37,083 60-capsule
bottles of lot 4D106; 9,716 100-capsule bottles of lot
4C017; and 7,000 100-capsule bottles of lot 4D016 were
distributed.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Metoclopramide Tablets, USP 5 mg, in 5 unit dose size
blister packs, Rx antiemetic.
Recall #D-177-5.
CODE Lot number on blister packs 3546-002 EXP 5/96.
MANUFACTURER Biocraft Laboratories, Inc., Elmwood Park, New Jersey.
RECALLED BY Vangard Labs, Inc., Glasgow, Kentucky, by letter May 9,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 367 blister packs were distributed.
REASON Subpotency.
_______________
PRODUCT 1000 mg Dobutamine HCl in 5% Dextrose Injection (4000
mcg/ml) 250 ml, indicated for the short-term treatment of
adults with cardiac decompensation due to depressed
contractility. Recall #D-178-5.
CODE Lot #PS026948 EXP 5/31/95.
MANUFACTURER Baxter Healthcare Corporation, Jayuya, Puerto Rico.
RECALLED BY Manufacturer, by letter May 15, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 10,350 units were distributed.
REASON A viaflex container of 1000 mg strength of Dobutamine and
Dextrose was found mislabeled as 500 mg Dobutamine/Dextrose.
The overpouch label was correct.
_______________
PRODUCT Oxygen, USP, transfilled into "E" size cylinders, under the
following labels: Exeter Community Medical Supply,
Portsmouth Community Medical Supply, and Medicine Shoppe
Pharmacy. Recall #D-180-5.
CODE None. All transfilled cylinders.
MANUFACTURER Wesco, Inc., doing business as Welders Supply Cryosource
Specialty Gases, Billerica, Massachusetts.
RECALLED BY Portsmouth Community Medical Supply, Exeter, New Hampshire,
by visit on or about May 4, 1995, followed by letter May 30,
1995. Firm-initiated recall ongoing.
DISTRIBUTION New Hampshire, Massachusetts, Maine.
QUANTITY Approximately 50 cylinders were distributed.
REASON Current good manufacturing practice deficiencies.
-2- _______________
PRODUCT Levothyroxine Sodium USP, (a) 0.1; (b) 0.125; (c) 0.15; (d)
0.2; (e) 0.3 mg Tablets, in bottles of 1,000, indicated as
replacement or substitution therapy for diminished or absent
thyroid function, Rx drug under the Rugby label.
Recall #D-181\185-5.
CODE Lot Numbers EXP Dates Lot Numbers EXP Dates
0.1 mg 303PR007 3/95 303PR028 4/95
304PR009 5/95 306PR001 6/95
306PR002 7/95 307PR004 8/95
307PR013 8/95 308PR006 8/95
308PR007 9/95 309PR013 10/95
309PR015 10/95 310PR007 10/95
310PR008 11/95 310PR022 11/95
310PR023 11/95 310PR024 11/95
311PR011 12/95 311PR012 12/95
311PR013 12/95 401PR005 2/96
401PR006 2/96 402PR008 2/96
403PR005 3/96
0.15 mg 301PR014 2/95 303PR017 3/95
303PR020 4/95 304PR015 4/95
305PR008 6/95 306PR005 6/95
306PR006 6/95 307PR007 8/95
307PR008 8/95 308PR008 9/95
308PR009 9/95 309PR012 10/95
309PR016 10/95 310PR012 11/95
310PR013 11/95 311PR008 11/95
311PR021 12/95 311PR022 12/95
401PR007 1/96 402PR006 3/96
402PR007 3/96 403PR011 4/96
403PR012 4/96
0.2 mg 303PR015 4/95 306PR008 7/95
308PR012 9/95 311PR007 11/95
312PR001 12/95 402PR012 3/96
0.3 mg 304PR016 5/95 308PR001 8/95
311PR006 11/95
0.125 mg 304PR001 4/95 308PR002 8/95
311PR009 12/95 401PR014 2/96
402PR013 3/96.
MANUFACTURER Chelsea Laboratories Caribe, Inc., Bayamon, Puerto Rico.
RECALLED BY Manufacturer, by letter February 22, 1995. Firm-initiated
recall complete.
DISTRIBUTION Georgia.
QUANTITY 140,035 units were distributed.
REASON Potency not assured through expiration date.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Triamcinolone Acetonide 0.1% Ointment, in 1 pound jars, Rx
constituent of a class of primary synthetic steroids used as
anti-inflammatory and antipruritic agents under the Rugby
label. Recall #D-179-5.
-3- CODE Control number V756 EXP 6/97.
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letter May 10, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Georgia.
QUANTITY 1,923 jars were distributed.
REASON Some units of Triamcinolone Cream 0.1% were mislabeled as
Triamcinolone Ointment 0.1%.
_______________
UPDATE Estratab (Esterified Estrogens Tablets, USP), 1.25 mg,
Recall #D-061-5, manufactured by Solvay Pharmaceuticals,
Baudette, Minnesota, which appeared in the February 15, 1995
Enforcement Report is being extended to include lot #84371.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Huber Needles and Infusion Sets, with or without Y
connectors, with 19", 20" and 22" needle gauges and needle
lengths of 1/2", 5/8", 3/4", 1", 1-1/4", or 1-1/2". Needles
are either straight or right angle, color varies, depending
on the size of the needle. Needle assemblies are used to
administer continuous and/or bolus infusions of pain control
medications, chemotherapeutic agents and parenteral
pharmaceuticals under the following labels: Noncor Port
Infusion Set, Non-Coring Needle 90 Bend, Winged Infusion Set
with 90 Huber Needle, Non-Coring (Huber) Needle, Winged
Infusion. Several devices are also sold in bulk under the
Harmac label. Recall #Z-780-5.
CODE Part numbers: B191+, B201+, B221+, B223+, IS191, IS191+,
IS193, IS193+, IS201, IS201+, IS203, IS203+, IS221, IS221+,
IS223, IS223+, IS225+, PIS191, PIS191+, PIS193, PIS193+,
PIS201, PIS201+, PIS2015+, PIS203, PIS203+, PIS221. PID221+,
PIS223, PIS223+, PIA225+, DT01, DT03, DT04, DT05, DT06,
DT07, DT08, DW04, DW05, DW06, DZ01, DZ02, EC03, EC05,
H2476001, HE0101, HE0K01, HE1D00, HE4C03, HE4K03, HE8405,
HE8C05, HEAC03, HNW1910, HNW1975, HNW2075, HNW2210, HNW2275,
IDM1910, IDM1910Y, IDM2275, IDM2010, IDM2010Y, IDM2075,
IDM2075Y, IDM2210, IDM2275, IDM2275Y, IPA-1910, IPA-2010,
IPA-2075, OKI9205, OKI9405, OKI9C05, OKI9105.
Lot Numbers: 6338-06, 6338-07, 6774-03, 6774-06, 6775-01
through 6775-05, 6775-07, 6832-04, 7070-01, 7070-02, 7125-
01A, 7127-01, 7138-04, 7138-05, 7225-01, 7225-02, 7237-02,
7239-01, 7246-01, 7268-01, 7290-01, 7328-01, 7328-02, 7340-
01, 7340-02, 7370-01 through 7370-04, H161401, H166405,
H174403, H174408, H174410, H202401, H202403, H202404,
H202408, H203402, H203403, H203405, H203406, H203411,
H203412, H203415, H203416, H223401, H223403, H223404,
H223408, H231401, H231402, H231403, H231404, H231408,
H231409, H231411, H231413, H231414, H231415, H231416,
-4- H231417, H213419, H231420, H231421, H231424, H231425,
H231426, H231427, H231428, H231430, H242401, H252401 through
H252409, H252412 through H252416, H264401, H264404, H264405,
H264406, H264407, H264408, H264409, H264411, H264412,
H270401, H270402, H270404, H270405, H270406, H270407,
H270408, H277403, H277404, H277408, H277409, H277414,
H277417, H278402, H285402, H285403, H285406, H285407,
H290403, H290404, H290405, H290407, H290408, H290409,
H290410, H290411, H290412, H293402, H298403, H298404,
H298405 through H298408, H306401, H306403, H306404, H306405,
H306406, H312401, H312402, H312403, H312404, H319401,
H319402, H319403, H319404, H326402, H326403, H333402,
H333403, H333404, H333405, H333406, H333408, H333409,
H334402, H334403, H334404, H334405, H334406, H347401.
MANUFACTURER Needle Specialty Products Corporation, Boyle, Mississippi
(component).
RECALLED BY Harmac Medical Products, Inc., Buffalo, New York, by letters
of March 6 and 31, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Florida, Kentucky, Michigan, Pennsylvania, Switzerland,
Italy, Germany, France, Japan.
QUANTITY 399,336 units were distributed.
REASON Incidents have been reported of a possible problem due to
needle occlusion caused by a manufacturing defect.
_______________
PRODUCT Chemspor 2 Chemical and Biological Indicators, a BI for
monitoring steam sterilization processes in wet
environments:
(a) Chemspor 2 Chemical and Biological Indicator, 100
Ampules per box, Reorder #NA230; (b) Chemspor 2 Chemical and
Biological Indicator, 25 Ampules per Box, Reorder #NA220;
(c) Chemspor 2 Chemical and Biological Indicator, 3 Ampules
per box (sampler), Reorder #NA225. Recall #Z-790/792-5.
CODE All lots within expiration. Lots C20013, C20014, C20015,
C20016.
MANUFACTURER AMSCO International, Inc., Apex, North Carolina.
RECALLED BY American Sterilizer Company, Erie, Pennsylvania, by letters
April 18, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,111 boxes are subject to recall.
REASON The product failed to meet the reduced incubation claim for
48 hours and the firm failed to file a 510(k) submission for
the reduced incubation time.
_______________
PRODUCT Gambro LunDia Alpha 600 Dialyzer. Recall #Z-796-5.
CODE Catalog #N01848004, Lot #5-0505-N.
MANUFACTURER Cobe Renal Care, Inc., Newport News, Virginia.
RECALLED BY Cobe Renal Care, Inc., Lakewood, Colorado, by telephone May
1-2, 1995, followed by letter. Firm-initiated recall
ongoing.
-5- DISTRIBUTION California, Connecticut, New Jersey, New York, Pennsylvania,
Virginia, Washington state, West Virginia, Washington, D.C.
QUANTITY 331 cases were distributed.
REASON The integrity of the sterile barrier may have been
compromised due to exposure to adverse weather.
_______________
PRODUCT Gambro LunDia Alpha 700 Dialyzer. Recall #Z-797-5.
CODE Catalog #N01849004, Lot #4-0766-N.
MANUFACTURER Cobe Renal Care, Inc., Newport News, Virginia.
RECALLED BY Cobe Renal Care, Inc., Lakewood, Colorado, by telephone May
4-5, 1995, followed by letter. Firm-initiated recall
complete.
DISTRIBUTION Delaware, Florida, North Carolina, New Jersey, New York,
Pennsylvania, Tennessee, Virginia, Washington, D.C..
QUANTITY 300 cases were distributed.
REASON The seal plugs were manufactured without a bevel resulting
in blood and/or dialysate leaks.
_______________
PRODUCT Yingling brand facial stimulating probes, used in
conjunction with Nerve Integrity Monitor-2 and Nerve
Integrity Monitor-2 XL Systems, used to stimulate exposed
facial motor nerves in order to identify the nerve's
location for the surgeon:
(a) Monopolar Stimulating Probe Package, Model 82-25250;
(b) Probe Tip Dispenser Box, Model 82-25205.
Recall #Z-815/816-5.
CODE All serial numbers.
MANUFACTURER XOMED Surgical Products, Jacksonville, Florida.
RECALLED BY Manufacturer, by letter on or about December 9, 1994. Firm-
initiated recall complete.
DISTRIBUTION California, Michigan, Washington State, Hawaii, France,
England.
QUANTITY 53 units were distributed.
REASON There may be defects in the products which could cause
intermittent functioning of the probe.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT MCCoy's 5A Medium Modified Cell Culture Medium:
(a) Catalog #16600-017; (b) Catalog #16600-025.
Recall #Z-799/800-5.
CODE Lot #16Q9348 EXP 11/30/95.
MANUFACTURER Life Technologies, Ltd., Paisley, Scotland.
RECALLED BY Life Technologies, Inc., Grand Island, New York, by letter
March 28, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 597 units; (b) 1,418 units.
REASON Possible bacterial contamination in the above referenced
lot.
-6- _______________
PRODUCT Software for the Electra 1000C Automatic Coagulation Timers.
Timers are used to test different chemical clotting factors
using human blood plasma: (a) Software for the Electra
Model 1000C, Automated Coagulation Timers; (b) Software for
the Electra Model No 1000C Automated Coagulation Timers with
Bar Code. Recall #Z-801/802-5.
CODE Software 3.2 and declining numerical versions for any 1000C
and 1000C with Bar Code Station models.
MANUFACTURER Medical Laboratories Automation Inc. (MLA), Pleasantville,
New York.
RECALLED BY Manufacturer, by letter March 23, 1993. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,415 units were distributed.
REASON The calculated values for both assays are incorrectly
reported under the area designated for the print out of the
results. The second software bug covers a software error
associated with the use of control samples for the Plasma
Reagent Rack (PRR).
-7-
END OF ENFORCEMENT REPORT FOR JUNE 7, 1995. BLANK PAGES MAY FOLLOW.
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