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 contain
s
information
on actions taken in connection with agency regulatory activities.
ENFORCE
08/28/1996
ENFORCEMENT REPORT FOR 08/28/96
August 28, 1996 96-35
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Barq's Root Beer in 12 fluid ounce aluminum
cans, 24 cans per case (multi-pak).
Recall #F-663-6.
CODE Product code numbers are: "APR 07 97 TBE 0710"
through "APR 07 97 TBE 0745". The soft drink
was produced on July 12, 1996.
MANUFACTURER Coca-Cola Bottling Company of Northern Ohio,
Division of Coca-Cola Enterprises, Twinsburg,
Ohio.
RECALLED BY Manufacturer, by electronic mail on August 1,
1996, and by telephone August 2, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Ohio.
QUANTITY 1,200 cans (50 cases, 24 cans per case) were
distributed.
REASON The regular root beer containers contains diet
root beer soda.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III =========
_______________
PRODUCT Maria Mia Blended Oil, in 1 gallon containers.
Recall #F-662-6.
CODE None.
MANUFACTURER Golden Grove Foods, Inc., Eastchester, New
York.
RECALLED BY Golden Grove Foods, Inc., Linden, New Jersey,
by letter dated December 24, 1995 and faxed on
February 12, 1996. Firm-initiated recall
complete.
DISTRIBUTION Florida.
QUANTITY 218 cases including 1,308 gallons were
distributed; firm estimates none remains on
the market.
REASON Product is misbranded due to incorrect soybean
and olive oil claims.
_______________
PRODUCT Various soft drink syrups in 5 gallon and 75
gallon stainless steel containers, 5 gallon
corrugated boxes with liners, 2.5 gallon
corrugated boxes with liners, and 1 gallon
plastic jugs:
(a) Caffeine Free Barq's Root Beer, in 5
gallon containers
(b) Coca Cola Classic, 75 gallon and 5 gallon
containers
(c) Fanta Lemonade FCB, in 5 gallon containers
(d) Hi-C Fruit Punch, in 5 gallon and 2.5
gallon containers
(e) HI-C Pink Lemonade, in 2.5 gallon
containers
(f) Minute Maid Orange, in 5 gallon, 1 gallon,
and 2.5 gallon containers
(g) Minute Maid Original Style Lemonade, in
2.5 gallon containers
(h) Mr Pibb, in 5 gallon containers.
Recall #F-664/671-6.
CODE Lot numbers: (a) 6P240711; (b) 6P110712,
6P310711; (c) 6P230711; (d) 6P270712; (e)
6P250715; (f) 6P260712; (g) 6P150712
(h) 6P300712.
MANUFACTURER Coca Cola USA Fountain, Portland, Oregon.
RECALLED BY Manufacturer, by telephone on July 15, 1996.
Firm-initiated recall complete.
DISTRIBUTION California, Idaho, Washington state, Montana,
Oregon.
QUANTITY (a) 115.0; (b) 2525.0; (c) 225.0; (d) 660.0
(e) 127.5; (f) 1481.5; (g) 62.5; (h) 840.0
gallons were distributed; firm estimates none
remains on the market.
REASON The product is adulterated due to the presence
of bird feathers
_______________
PRODUCT Various carbonated soft drinks:
(a) Classic Coke, in 12 ounce cans;
(b) Classic Coke in 8 ounce bottles;
(c) Minute Maid Orange, in 12 ounce cans;
(d) Cherry Coke, in 12 fluid ounce cans;
(e) Mr. Pibb, in 12 ounce cans.
Recall #F-672/676-6.
CODE Lot numbers: (a) APR0797VJE; (b) APR0797VJD,
APR1497VJA, APR1497VJB; (c) APR1497VJA; (d)
APR1497VJA; (e) APR1497VJA.
MANUFACTURER Coca-Cola Bottling Company of Oregon, a
division of Coca-Cola Enterprises,
Wilsonville, Oregon.
RECALLED BY Manufacturer, by telephone on July 15, 1996.
Firm-initiated recall complete.
DISTRIBUTION Washington state and Oregon.
QUANTITY Cases Produced:
Classic 6 pack 10,785
Classic 12 pack 62,638
MM Orange 6 pack 8,766
MM Orange 12 pack 12,313
Cherry Coke 6 pack 5,265
Cherry Coke 12 pack 10,111
Mr. PiBB 6 pack 2,383
Mr. PiBB 12 pack 6,211
Classic 8 oz. bottles 9,612
REASON The product is adulterated due to the presence
of bird feathers
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Esgic Tablets containing 50-mg Butalbital,
325-mg. Acetaminophen, and 40-mg Caffeine,
USP, 100-count bottles, packaged 144 bottles
per case, Rx product indicated for the relief
of the symptom complex of tension (or muscle
contraction) headache. Recall #D-227-6.
CODE LOT # EXPIRATION DATE
GE337A 05/97
GE338A 05/97
GE341A 05/97
GE342A 05/97
GE348A 07/97
GE349A 07/97
GE350A 07/97
GE351A 07/97
GE352A 07/97
GE353A 09/97
GE354A 09/97
GE355A 10/97
GE356A 10/97
GE360A 03/98
GE361A 03/98
GE362A 03/98
GE369A 06/98
GE370A 06/98
GE380A 11/98
GE381A 11/98
GE382A 04/99
GE383A 04/99
GE391A 06/2000
GE394A 12/2000.
MANUFACTURER Graham Labs., Inc., Hobart, New York
(responsible firm).
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis,
Missouri, by letter dated July 29, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 218,004 bottles were distributed.
REASON 11 of the 24 recalled lots failed dissolution
on stability test.
_______________
PRODUCT Mylanta, Double Strength Cherry Cream Antacid
Tablets, chewable, packaged in 70 tablet
boxes. Recall #D-228-6.
CODE SAF EXP 11/97.
MANUFACTURER Johnson & Johnson Merck, Lancaster,
Pennsylvania.
RECALLED BY Johnson & Johnson Merck, Consumer
Pharmaceuticals Company, Fort Washington,
Pennsylvania, by telephone on July 31, 1996,
followed by fax, letter, and visit. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that little, if any product
remained on market at time of recall
initiation.
REASON One lot was found to contain metal wire.
_______________
PRODUCT Albuterol Sulfate (generic and trade name)
Syrup, 2 mg/5 ml, in 1 pint (16 fluid ounce)
bottles, under the Duramed and Dey labels,
used for the relief of bronchospasm. Recall
#D-230/231-6.
CODE (a) Lot #MLL0031A EXP 1/97 (Duramed); (b) Lot
#MNL0461A EXP 1/97 (Dey); (c) Lot #MLL1311A
EXP 1/97 (Mova).
MANUFACTURER MOVA Pharmaceuticals, Caguas, Puerto Rico.
RECALLED BY Manufacturer, by letter on August 9, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 8,901; (b) 9,385); (c) 9,345 bottles were
distributed; firm estimated that 25 percent of
product remained on market at time of recall
initiation.
REASON Three lots (all portions of one MOVA
manufactured batch) under three labels were
found to be contaminated with Pseudomonas
cepacia. (Note: Another portion of this same
MOVA batch was previously recalled by UDL in
July 1996 (D-212-6)).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Rugby brand Bacitracin Ointment, USP 500
units/gram, net weight 1 pound, OTC used to
help prevent infections in minor cuts, burns,
and scrapes. Recall #D-229-6.
CODE Lot #4K366 EXP 11/96.
MANUFACTURER NMC Laboratories, Glendale, New York
(responsible firm).
RECALLED BY Manufacturer, by letter dated August 7, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 224 1-pound units were distributed; firm
estimates none remains on the market.
REASON Subpotent (86.9%) of label strength at the 20-
month timepoint; product is labeled to have a
24-month expiration period.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT TAPSYSTEM 2A Esophageal Pacing System, also
called Esophageal Pulse Generator, indicated
for the treatment of cardiac disorders that
require alteration of rate rhythm and for
alteration of rate as required for certain
diagnostic studies. Recall #Z-981-6.
CODE 487 nonsequential serial numbers are involved.
MANUFACTURER Seecor, Inc., Mesquite, Texas.
RECALLED BY Arzco Medical Systems, Inc. (AMS), Tampa,
Florida, by letter dated May 9, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 487 units were distributed.
REASON Devices malfunction when subjected to
electromagnetic interference (EMI) from
electrosurgical (ESU) units used in surgical
environment.
_______________
PRODUCT Sat-Pace II Esophageal Pacing System, also
called Esophageal Pulse Generator, indicated
for the treatment of cardiac disorders that
require alteration of rate rhythm of certain
diagnostic studies. Recall #Z-982-6.
CODE Serial numbers 1001, 1002, 1003, 1004, 1008,
12593, 33090, 41293, 41592, 62591, 80190,
82326, 85619, 91092, 01186A, 022487, 081887,
071188, 073187, 101287, 103092, 111491,
112390, 112989, 120788, 122286, 122287,
820131, 820209, 840215-S, 820319, 820510,
820603, 820719, 820818, 821206.
MANUFACTURER Seecor, Inc., Mesquite, Texas.
RECALLED BY Manufacturer, by letter dated June 21, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 61 units were distributed.
REASON Devices malfunction when subjected to
electromagnetic interference (EMI) from
electrosurgical (ESU) units used in surgical
environment.
_______________
PRODUCT SynchroMed Programmable Pump, Model 8617L-18,
a drug infusion pump. Recall #Z-1035-6.
CODE Serial numbers: NDA000356R and NDA000390R.
MANUFACTURER Medtronic, Inc., Neurological Division,
Minneapolis, Minnesota.
RECALLED BY Medtronic, Inc., Neurological Division,
Columbia Heights, Minnesota, by telephone July
3, 1996. Firm-initiated recall complete.
DISTRIBUTION California and Oregon.
QUANTITY 2 units were distributed and recovered.
REASON Traceability records for two pumps were
incomplete.
_______________
PRODUCT Disetronic Rapid Subcutaneous Infusion Sets:
(a) Product Code 300.0253, 8 mm needle length,
60 cm Rapid Subcutaneous IV Infusion set;
(b) Product Code 300.0255, 8 mm needle length,
110 cm Rapid Subcutaneous IV Infusion set;
(c) Product Code 300.0258, 10 mm needle
length, 110 cm Rapid Subcutaneous IV Infusion
set. Recall #Z-1036/1038-6.
CODE Lot numbers: (a) 504313; (b) 504315 & 504316;
(c) 504293 & 504294.
MANUFACTURER Maersk Medical, a/s, Roskildee, Denmark.
RECALLED BY Disetronic Incorporated, Minneapolis,
Minnesota, by letter on June 14, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 14,175 units were distributed; firm estimated
that 13,071 units remained in commerce at time
of recall initiation.
REASON Inadequate manufacturing may cause the needle
to break during use.
_______________
PRODUCT Triad Whole Body SPECT Nuclear Imaging
Systems, also known as Triad 88 Triple Headed
Camera, used primarily for whole body imaging,
cardiac, renal, brain and bone scans.
Recall #Z-1039-6.
CODE All codes.
MANUFACTURER Trionix Research Laboratory, Twinsburg, Ohio.
RECALLED BY Manufacturer, by telephone on May 14, 1996,
followed by visit. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide, Belgium, England, Korea,
Australia, Egypt.
QUANTITY 38 systems were distributed.
REASON The detector head may drop on a patient or
healthcare provider because of metal fatigue
at the devices' ball screw assembly and an
inadequately designed limit switch.
_______________
PRODUCT Home Uterine Activity Monitor, Model Carefone
2001. Recall #Z-1040-6.
CODE Serial numbers: (a) C0256 thru C0425; (b)
C0436 thru C0685.
MANUFACTURER Carelink Corporation, Irvine, California.
RECALLED BY Carelink Corporation, Santa Ana, California,
by voice mail May 10, 1993, and by letter May
13, 1993. Firm-initiated recall completed.
DISTRIBUTION California, Neveda, Illinois, Texas, New York,
Washington state.
QUANTITY 180 units were distributed.
REASON The disk drive may fail resulting in failure
of the units to boot and possible loss of
recorded information.
_______________
PRODUCT Sterile Cytology Brushes, used in combination
with bronchoscope for the collection of cell
samples from bronchi tracts.
Recall #Z-1042-6.
CODE Catalog No. CYB-182122, Lot Numbers: 93CY004,
93CY010, 93CY014, 93CY024, 93CY029, 93CY051,
and 93CY057.
MANUFACTURER Cox Medical Enterprises, Inc., Ventura,
California.
RECALLED BY Manufacturer, by telephone on October 8, 1993,
and by letter on October 26, 1994. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 1,221 units were distributed from January 1993
to May 1993. Firm estimates none remains on
the market.
REASON The bristle component can be separated from
the bronchoscope during the collection of cell
samples from the bronchi tract.
_______________
PRODUCT Davis-Geck Valtrac Bar Biofragmentable
Anastomosis Ring, Rx device designed to
facilitate anastomosis of the inverted ends of
the bowel and then to fragment and pass out of
the body:
(a) Product No. 8082-00, 25mm Diameter x 1.5
mm Gap
(b) Product No. 8030-00, 25mm Diameter x 2.0
mm Gap
(c) Product No. 8084-00, 25mm Diameter x 2.5mm
Gap
(d) Product No. 8087-00, 28mm Diameter x 1.5mm
Gap
(e) Product No. 8088-00, 28mm Diameter x 2.0mm
Gap
(f) Product No. 8089-00, 31mm Diameter x 1.5mm
Gap
(g) Product No. 8090-00, 31mm Diameter x 2.0mm
Gap
(h) Product No. 8091-00, 34mm Diameter x 2.0mm
Gap
(i) Product No. 8092-00, 34mm Diameter x 2.5mm
Gap. Recall #Z-1043/1051-6.
CODE All Control Numbers.
MANUFACTURER Davis & Geck, Danbury, Connecticut.
RECALLED BY Sherwood Medical Company, St. Louis, Missouri,
by letters of May 22 and 23, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Canada and international.
QUANTITY 12,000 units were distributed.
REASON The scalloped edges of the device edges may be
oriented peak-to-peak rather than
peak-to-valley as intended.
_______________
PRODUCT Sceptor System Panels for use with Sceptor
Broths for identification and/or
susceptibility testing of bacteria from
clinical specimens. Recall #Z-1055/1094-6.
CODE 1. Catalog No. 80425, Sceptor Enteric MIC
Panels, Lot Nos. 411308, 501319, 503314;
2. Catalog No. 80426, Sceptor Enteric MIC/ID
Panels, Lot Nos. 408315, 410312, 412300,
412311, 501324, 502315, 503307, 504300;
3. Catalog No. 80428, Sceptor Pseudomonas MIC
Panels, Lot Nos. 408310, 411301, 502309,
504301;
4. Catalog No. 80429, Sceptor Pseudomonas
MIC/ID Panels, Lot Nos. 408322, 410329,
501305, 502313;
5. Catalog No. 80430, Sceptor Gram Negative
Breakpoint ID Panels, Lot Nos. 408318, 410327,
412312, 501327, 503302, 503313, 504302;
6. Catalog No. 84390, Sceptor Urinary
Breakpoint ID Panels, Lot Nos. 410303, 410330,
411307, 411316, 501304, 501318, 502312,
503316;
7. Catalog No. 84391, Sceptor Gram Negative
Breakpoint ID Panels, Lot Nos. 410301, 411306,
501315, 502320, 504303;
8. Catalog No. 84401, Sceptor Pseudomonas
Plus MIC/ID Panels, Lot Nos. 411320, 503308;
9. Catalog No. 84406, Sceptor Gram Negative
MIC/ID Panels, Note: Last manufactured lot
was 406313;
10. Catalog No. 84410, Sceptor Urine
Breakpoint/ID Panels, Note: Last manufactured
lot was 404311;
11. Catalog No. 84416, Sceptor MIC Panels,
Lot No. 408309;
12. Catalog No. 84488, Sceptor Enteric
Breakpoint Panels; Note: Last manufactured
lot was 304318;
13. Catalog No. 84489, Sceptor Pseudomonas
Breakpoint Panels; Note: Last manufactured
lot was 305302;
14. Catalog No. 84490, Sceptor S-I Breakpoint
Panels; Note: Last manufactured lot was
307310;
15. Catalog No. 84572, Sceptor Gram Negative
Breakpoint/ID Panels;
16. Catalog No. 84621, Sceptor Gram Negative
Breakpoint/ID Panels, Lot No. 412306;
17. Catalog No. 84801, Sceptor Pseudomonas MIC
Panels; Note: Last manufactured lot was
309314;
18. Catalog No. 84803, Sceptor Gram Negative
MIC Panels, Lot Nos. 409309, 411326, 501313,
504306;
19. Catalog No. 84821, Sceptor Gram Negative
Breakpoint Panels, Lot Nos. 410320, 412310,
504308;
20. Catalog No. 84822, Sceptor Gram Negative
MIC Panels, Lot No. 501322;
21. Catalog No. 84824, Sceptor Gram Negative
MIC/ID Panels, Lot Nos. 410325, 412313,
502318;
22. Catalog No. 84828, Sceptor Breakpoint No.
8 Panels, Lot Nos. 408324, 410316, 411323,
501307, 501308, 502319, 503318;
23. Catalog No. 84829, Sceptor Gram Negative
MIC 3 Panels, Lot NO. 410317;
24. Catalog No. 84830, Sceptor MIC Panels, Lot
Nos. 411302, 503304;
25. Catalog No. 84831, Sceptor Gram Negative
Breakpoint/ID 2 Panels, Lot Nos. 411319,
411321, 411322, 412315, 512315, 502321,
503320;
26. Catalog No. 84833, Sceptor Gram Negative
Breakpoint/ID 3 Panels, Lot Nos. 408306,
411324, 502304, 504307;
27. Catalog No. 84834, Sceptor Gram Negative
Breakpoint/4 Panels, Lot Nos. 409304, 411325,
502306;
28. Catalog No. 84836, Sceptor MIC 1 Panels,
Lot Nos. 408302, 410322, 412302, 502303,
504312*;
29. Catalog No. 84839, Sceptor Gram Negative
MIC 2 Panels, Lot Nos. 409311, 502307;
30. Catalog No. 84841, Sceptor Breakpoint No.
9 Panels; Note: Last manufactured lot was
211310;
31. Catalog No. 84842, Sceptor Breakpoint No.
10 Panels, Lot Nos. 408300, 409310, 410319,
411303, 501303, 501326, 503306;
32. Catalog No. 84845, Sceptor Breakpoint No.
9 Panels, Lot Nos. 412308, 503319;
33. Catalog No. 84846, Sceptor Gram Negative
Breakpoint Panels, Lot Nos. 408304, 502317;
34. Catalog No. 84847, Sceptor Breakpoint No.
11 Panels, Lot Nos. 408305, 409300, 501301;
35. Catalog No. 84848, Sceptor Breakpoint/MIC
No. 12 Panels, Lot Nos. 409312, 503300;
36. Catalog No. 84853, Sceptor Pseudomonas
MIC/ID Panels, Lot Nos. 501311;
37. Catalog No. 84854, Sceptor Enteric MIC/ID
Panels, Lot No. 410300;
38. Catalog No. 99237, Sceptor Universal
MIC/ID Panels, Lot No. 408312;
39. Catalog No. 99255, Sceptor Gram Negative
MIC/ID Panels, Lot No. 410314;
40. Catalog No. 99256, Sceptor Gram Negative
MIC/ID Panels, Lot Nos. 407308, 410321.
Key: * BDMS QC Testing still in progress as of
5/18/95; lot not yet released.
MANUFACTURER Becton Dickinson Microbiology Systems,
Cockeysville, Maryland.
RECALLED BY Manufacturer, by letter on June 9, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Belgium, Mexico, Singapore,
Taiwan, Japan, Canada.
QUANTITY Approximately 29,096 units were distributed;
firm estimates none remains on the market.
REASON A CAP proficiency test survey strain gave
false susceptible results.
RECALLS AND FIELD CORRECTIONS: DEVICES: CLASS III =========
_______________
PRODUCT Wrist Blood Pressure Monitor, Model #1090, an
OTC device and an auto inflating unit with
pulse meter, digital LCD with memory and
"Fuzzy logic", designed for portable use by
the lay person. Recall #Z-1041-6.
CODE None. Purchase order #12269.
MANUFACTURER Rossmax International, Ltd., Taipei, Taiwan.
RECALLED BY The Lumiscope Company, Inc., Edison, New
Jersey, by telephone followed by letter on or
about January 12, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 900 units were distributed.
REASON The instruction manual shipped with the device
was printed partially in English and partially
in French.
_______________
PRODUCT Single Use Y-Set with QDC (quick disconnect
clamp), Rx device used in peritoneal dialysis
treatment. Recall #Z-1052-6.
CODE Catalog #48-6361, Lot #R4K505.
MANUFACTURER National Medical Care, Reynosa, Mexico.
RECALLED BY National Medical Care, Medical Products,
Division, Rockleigh, New Jersey, by letter
dated December 21, 1994. Firm-initiated
recall complete.
DISTRIBUTION Florida, Georgia, Massachusetts, Maine,
Mississippi, North Carolina, Puerto rico,
Rhode Island, South Carolina, Tennessee,
Virginia, Kentucky.
QUANTITY 17,550 units were distributed; firm estimates
none remains on the market.
REASON The male connector may develop visible cracks
resulting in breakage or leakage during use.
_______________
PRODUCT Amicon Diafilter-30 Hemoconcentrators, Catalog
#18-3170-0, used for extracorporeal
circulation. Recall #Z-1053-6.
CODE Lot numbers: D30-0603 and D30-0609.
MANUFACTURER Amicon Ireland Limited.
RECALLED BY National Medical Care, Rockleigh, New Jersey,
by letter dated December 21, 1994. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,241 units were distributed.
REASON There is no assurance that the devices are
pyrogen free.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I
=========
_______________
UPDATE Bulk Supersweet Feeds Commercial 25/50
Medicated, Recall #V-022-6, which appeared in
the August 21, 1996 Enforcement Report should
read: Firm-initiated recall complete as of
June 7, 1996.
END OF ENFORCEMENT REPORT FOR AUGUST 28, 1996. BLANK PAGES MAY FOLLOW.
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