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
07/17/1996
ENFORCEMENT REPORT FOR 07/17/96
July 17, 1996 96-29
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Jarlsberg Cheese in clear plastic vacuum
package. Recall #F-619-6.
CODE Product with sell by date codes 10-07-96
through 11-30-96.
MANUFACTURER Norwegian Dairies, Oslo, Norway .
RECALLED BY The Peterson Company, Auburn, Washington
(distributor), by telephone on June 7, 1996,
followed by fax. Firm-initiated recall
complete.
DISTRIBUTION Washington state, Oregon, Utah, California,
Alaska, Hawaii, Idaho, Nevada, Montana, Guam.
QUANTITY 30,727 pounds were distributed.
REASON The product is contaminated with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Bowlby's Bits'N'Pops Pure Butter Gourmet
Caramel Corn, in 12 ounce packages.
Recall #F-618-6.
CODE All misbranded product.
MANUFACTURER Bowlby Candy Company, Waupaca, Wisconsin.
RECALLED BY Manufacturer, by letter dated June 3, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 20,000 packages were
distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Distilled White Vinegar and Red Wine Vinegar
packaged in 1 quart, 1/2 gallon, and 1 gallon
plastic containers labeled as follows:
(a) White Distilled Vinegar
i) Ce Prio White Vinegar, Distilled, Reduced
with Water to 5% Acidity, 1 quart, 1 gallon,
distributed by: Ce Prio, Inc., Des Plaines,
Illinois
ii) Greenwood Fruit Market White Vinegar,
Distilled, Reduced with Water to 5% Acidity,
net weight 1 gallon
(b) Red Wine Vinegar:
i) Ce Prio Wine Vinegar, Italian Style,
Reduced with Water to 5% Acidity, 1 quart, 1/2
gallon, 1 gallon, distributed by: Ce Prio,
Inc., Des Plaines, Illinois
ii) La Bella Romana Wine Vinegar (Italian
Style), Reduced with Water (5% Acidity), 1
quart, distributed by Intercontinentale Imp.
Distributors Inc., Chicago, Illinois
iii) Greenwood Fruit Market Wine Vinegar,
Reduced with Water to 5% Acidity, net weight 1
gallon. Recall #F-613/614-6.
CODE Not coded -- All product.
MANUFACTURER Ce Prio Inc., Des Plaines, Illinois.
RECALLED BY Manufacturer, by telephone on April 26, 1996,
followed by letter on April 30, 1996. Firm-
initiated recall complete.
DISTRIBUTION Illinois and Wisconsin.
QUANTITY Approximately 3,800 gallons of vinegar were
distributed.
REASON The products do not qualify as vinegar due to
acetic acid levels below the 4% specified in
CPG 525.825.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Triofed Syrup, in 4 ounce bottles, a nasal
decongestant antihistamine. Recall #D-170-6.
CODE Lot #RC5180 EXP 3/97.
MANUFACTURER Barre-National, Inc., Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated June 3, 1996.
Firm-initiated recall ongoing.
-2- DISTRIBUTION New Jersey, California, Connecticut, Illinois,
Florida, New York, Texas.
QUANTITY 2,880 units were distributed; firm estimated
that very little product remained in commerce
at time of recall initiation.
REASON Incomplete label warning statement.
_______________
PRODUCT Oxygen USP packed in C, E and M-6 size high
pressure aluminum cylinders. Recall #D-171-6.
CODE All codes.
MANUFACTURER Halprin, Inc., Canandaigua, New York.
RECALLED BY Manufacturer, by visit from June 26, 1996
through July 15, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION New York.
QUANTITY 69 cylinders were distributed.
REASON Current good manufacturing practice
deficiencies.
_______________
PRODUCT SoloPak Sterile Solutions in pre-filled
syringes:
(a) SoloPak Heparin Lock Flush Solution, USP,
Preservative Free, 10 USP units/ml packaged in
3 ml pre-filled syringes, for maintenance of
patency of intravenous injection devices only,
not to be used for anticoagulant therapy:
i) Catalog #10683: 3 ml Hy-Pod Syringe, needle
not included, 120 per case
ii) Catalog #11773: 3 ml Hy-Pod Syringe,
contained in the Lok-Pak-N Heparin Lock Flush
Procedure Pack, 200 per case,
(b) SoloPak Sodium Chloride Injection USP,
0.9%; packaged in 3 ml and 5 ml pre-filled
syringes; a vehicle for diluting or dissolving
compatible parenteral medications
i) Catalog #06003: 3 ml Hy-Pod Syringe,
contained in the Lok-Pak Heparin Lock Flush
Procedure Pack, needle not included, 200 per
case
ii) Catalog #11275: 5 ml Hy-Pod Syringe, 120
per case
iii) Catalog #11285: 5 ml Hy-Pod Syringe,
needle not included, 120 per case.
Recall #D-172/173-6.
CODE Lot numbers: (a) 95M020C, 95M020B; (b)
96B013B, 96A023B, 96A023C, 96A023D
MANUFACTURER SoloPak Medical Products Inc., Franklin Park,
Illinois.
RECALLED BY SoloPak Medical Products Inc., Elk Grove
Village, Illinois, by letter dated June 28,
1996. Firm-initiated recall ongoing.
-3- DISTRIBUTION Nationwide.
QUANTITY 167,400 syringes were distributed; firm
estimated that 73% of the syringes remained on
market at time of recall initiation.
REASON Lack of assurance of sterility.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-481/482-6.
CODE Unit numbers: (a) 8112041, 8125646; (b)
8112041.
MANUFACTURER Permian Basin Regional Blood Center, Midland,
Texas.
RECALLED BY Manufacturer, by letter dated September 30,
1995. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY (a) 2 units; (b) 1 unit.
REASON Blood products, which tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), the hepatitis B surface
antigen (HBsAg), the antibody to the hepatitis
B core antigen (anti-HBc), the antibody to the
hepatitis C virus encoded antigen (anti-HCV),
the antibody to the human T-lymphotropic virus
type 1 (anti-HTLV-1), and syphilis but were
collected from donors in which donor
suitability was not adequately determined,
were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma. Recall #B-509/511-6.
CODE Unit #701356.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by telephone on October 4, 1995,
and by letter dated October 25, 1995. Firm-
initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component.
REASON Blood products, not tested for infectious
diseases, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets, Pheresis;
(c) Fresh Frozen Plasma. Recall #B-514/516-6.
CODE Unit numbers: (a) G14417; (b) G14417;
(c) P23661.
MANUFACTURER Central California Blood Center, Fresno,
California.
RECALLED BY Manufacturer, by letter on March 22, 1996.
Firm-initiated recall complete.
-4- DISTRIBUTION California.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor who
received a tattoo and three ear piercings
within twelve months of donation, were
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT (a) Platelets, Expired; (b) Recovered Plasma.
Recall #B-483/484-6.
CODE Unit numbers: (a) 8125646; (b) 8112041,
8125646.
MANUFACTURER Permian Basin Regional Blood Center, Midland,
Texas.
RECALLED BY Manufacturer, by fax dated September 30, 1995,
and by letter mailed October 2, 1995 and
letter dated December 4, 1995. Firm-initiated
recall complete.
DISTRIBUTION Colorado.
QUANTITY (a) 1 unit; (b) 2 units.
REASON Blood products, which tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), the hepatitis B surface
antigen (HBsAg), the antibody to the hepatitis
B core antigen (anti-HBc), the antibody to the
hepatitis C virus encoded antigen (anti-HCV),
the antibody to the human T-lymphotropic virus
type 1 (anti-HTLV-1), and syphilis but were
collected from donors in which donor
suitability was not adequately determined,
were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Polytron T.O.P. Fluoroscopic Imaging System
with Parallel Fluoroscopy Mode.
Recall #Z-946-6.
CODE Model #2968373G120U.
MANUFACTURER Siemens Medical Systems, Inc., Iselin, New
Jersey.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan July 5, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 30 units.
-5- REASON The device was found to be in noncompliance
with Section 21 CFR 1020.32(h), in that the
required audible signal to indicate expiration
of 5 minutes of cumulative on-time of the
fluoroscopic tube does not function when the
optional Parallel Fluoroscopy Mode is
selected.
_______________
PRODUCT ICON Software versions less than 5.0 for use
with Integrated Orbiter, Integrated Diacam,
Multispect 2 and Multispect 3 Gamma Camera
Systems. Recall #Z-944-6.
CODE All units with ICON software versions less
than 5.0.
MANUFACTURER Siemens Medical Systems, Inc., Hoffman
Estates, Illinois.
RECALLED BY Manufacturer, by initiating a Mandatory Next
Service Call Field Modification Instruction
(FMI-00143). Firm-initiated field correction
complete.
DISTRIBUTION Nationwide.
QUANTITY 409 units were distributed.
REASON The software had "bugs" which caused loss of
image data.
_______________
PRODUCT Monoclonal Mouse Anti-pneumocystis Carinii, an
in-vitro diagnostic used for detection of
pneumocystis carinii cysts isolated from human
lung. Recall #Z-950-6.
CODE Catalog #M0778, Lot numbers: 074 EXP 6/97,
03511 EXP 5/98, 03512 EXP 5/98.
MANUFACTURER DAKO A/S, Glostrup, Denmark.
RECALLED BY DAKO Corporation, Carpinteria, California, by
letter mailed on or about June 19, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 116 units were distributed.
REASON The staining procedure for the detection of P.
carinii by Indirect Immunofluorescence was not
acceptable in the firm's 510(k) submission.
_______________
PRODUCT MicroScan Dried Gram Positive Breakpoint Combo
Type 8 Panels, No Catalog number listed.
Recall Z-953-6.
CODE Lot No. 20SEP96;
MANUFACTURER MicroScan, Inc. (AKA) Dade International, West
Sacramento, California.
RECALLED BY Manufacturer, by telephone on December 14-19,
1995, followed by letter sent December 18,
1995. Firm-initiated recall complete.
-6- DISTRIBUTION Nationwide and international.
QUANTITY 674 boxes were distributed.
REASON There were out of range results on the
ampicillin portion of the panel.
_______________
PRODUCT MicroScan Dried Gram-Positive Panels:
Erythromycin Performance with Staphylococcus
Aureus. Recall #Z-957-6.
Code Catalog# Panel Type
1. B1017-103 Pos Combo 9 Panel
Lot numbers: 12SEP96, 28SEP96, 09NOV96
15DEC96
2. B1017-104 Pos BP Combo 8 Panel
Lot Numbers: 22AUG96, 20SEP97, 16OCT96
07DEC96, 03JAN97
3. B1017-105 Pos MIC 9 Panel
Lot Numbers: 01NOV96, 18NOV96
4. B1017-44DL Pos MIC 9 Panel
Lot numbers: 01NOV96, 18NOV96
5. B1017-60 Pos Combo 6 Panel
Lot numbers: 08JUN96, 13JUN96, 15JUN96,
19JUN96, 21JUN96, 26JUN96, 27JUN96,
29JUN96, 29JUN96, 06JUL96, 11JUL96,
17JUL96, 18JUL96, 19JUL96, 20JUL96,
24JUL96, 25JUL96, 27JUL96, 11AUG96,
16AUG96, 19AUG96, 21AUG96, 22AUG96,
23AUG96, 25AUG96, 26AUG96, 28AUG96,
30AUG96, 31AUG96, 01SEP96, 06SEP96,
11SEP96, 18SEP96, 21SEP96, 22SEP96,
30SEP96, 02OCT96, 03OCT96, 04OCT96,
10OCT96, 14OCT96, 20OCT96, 23OCT96,
24OCT96, 25OCT96, 26OCT96, 27OCT96,
28OCT96, 30OCT96, 31OCT96, 08NOV96,
10NOV96, 11NOV96, 13NOV96, 14NOV96,
17NOV96, 18NOV96, 20NOV96, 21NOV96,
27NOV96, 29NOV96, 30NOV96, 01DEC96,
02DEC96, 04DEC96, 05DEC96, 06DEC96,
14DEC96, 15DEC96, 18DEC96, 21DEC96,
28DEC96, 03JAN97, 04JAN97
6. B1017-61 Pos BP Combo 6 Panel
Lot numbers: 06JUN96, 09JUN96, 12JUN96,
13JUN96, 15JUN96, 19JUN96, 26JUN96,
29JUN96, 10JUL96, 20JUL96, 24JUL96,
16AUG96, 17AUG96, 19AUG96, 21AUG96,
22AUG96, 24AUG96, 26AUG96, 29AUG96,
30AUG96, 31AUG96, 01SEP96, 19SEP96,
26SEP96, 27SEP96, 28SEP96, 30SEP96,
09OCT96, 11OCT96, 14OCT96, 16OCT96,
17OCT96, 20OCT96, 27OCT96, 28OCT96,
09NOV96, 10NOV96, 13NOV96, 14NOV96,
-7- 16NOV96, 20NOV96, 27NOV96, 02DEC96,
05DEC96, 06DEC96, 08DEC96, 14DEC96,
18DEC96, 20DEC96, 28DEC96, 29DEC96,
03JAN97, 04JAN97, 05JAN97
7. B1017-62 Pos MIC Panel Type 6-D
Lot numbers: 15JUN96, 20JUN96, 22JUN96,
30JUN96, 13JUL96, 14JUL96, 18JUL96,
20JUL96, 16AUG96, 17AUG96, 19AUG96,
23AUG96, 24AUG96, 25AUG96, 28AUG96,
29AUG96, 01SEP96, 05SEP96, 13SEP96,
14SEP96, 19SEP96, 26SEP96, 27SEP96,
30SEP96, 02OCT96, 05OCT96, 12OCT96,
13OCT96, 16OCT96, 18OCT96, 03NOV96,
07NOV96, 15NOV96, 18NOV96, 12NOV96,
25NOV96, 29NOV96, 30NOV96, 06DEC96,
08DEC96, 12DEC96, 18DEC96, 20DEC96,
21DEC96, 26DEC96, 04JAN97
8. B1017-90 Pos MIC Panel Type 8-D
Lot numbers: 06JUN96, 20JUN96, 06JUL96,
19AUG96, 22SEP96, 03NOV96, 07NOV96,
14DEC96, 05JAN97
9. B1019-16CHC Childrens Pos MIC Panel
Lot numbers: 05SEP96, 07NOV96
INTERNATIONAL PANEL TYPES
10. B1016-23A Pos Combo 41 Panel
Lot numbers: 28JUN96, 13JUL96, 23AUG96,
07SEP96, 27SEP96, 09OCT96, 10NOV96,
29NOV96, 07DEC96
11. B1016-27A Pos Combo 31 Panel
Lot numbers: 04OCT96, 27NOV96, 28DEC96
12. B1016-30A Pos BP Combo 21 Panel
Lot numbers: 16JUN96, 11SEP96, 08NOV96,
29NOV96
13. B1016-41A Pos Combo 6E Panel
Lot number: 17JUL96
14. B1016-45A Pos BP Combo 3E Panel
Lot Number: 29DEC96
15. B1016-48 Pos BP Combo 4E Panel
Lot Numbers: 31AUG96, 21SEP96
16. B1016-48A Neg BP Combo 1E Panel
Lot Number: 23OCT96
17. B1016-59 Pos BP Combo 8E Panel
Lot Numbers: 23OCT96, 16NOV96
18. J1016-29A Pos BP Combo TY 1J Panel
Lot Numbers: 06JUN96, 05JUL96, 14AUG96,
28AUG96, 18SEP96, 02OCT96, 20OCT96,
30NOV96
19. J1016-30A Pos Combo Type 2J Panel
Lot Numbers: 08JUN96, 05JUL96, 06JUL96,
07JUL96, 02AUG96, 04AUG96, 07AUG96,
14AUG96, 16AUG96, 18AUG96, 01SEP96,
-8- 05SEP96, 06SEP96, 08SEP96, 11SEP96,
18SEP96, 20SEP96, 22SEP96, 04OCT96,
09OCT96, 14OCT96, 18OCT96, 28OCT96,
10NOV96, 11NOV96, 17NOV96, 28NOV96,
04DEC96, 14DEC96, 15DEC96, 19DEC96
20. J1016-31A Pos MIC Panel Type 1J
Lot number: 07NOV96
21. J1016-39C Chiba Pos Combo 1C Panel
Lot Numbers: 15SEP96, 30SEP96, 19DEC96
22. J1016-47B Pos Combo Type 2J Panel
Lot Number: 18SEP96
23. J1016-48A Pos BP Type 2J Panel
Lot Number: 16SEP96
24. J1016-52C Pos Combo Type 2C Panel
Lot Number: 16SEP96.
MANUFACTURER MicroScan, Inc. also known as DADE
International, West Sacramento, California.
RECALLED BY Manufacturer, by Federal Express on February
22, 1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 268 panels were distributed.
REASON There is a potential for an increase in false
susceptible erythromycin results with clinical
strains of S. Aureus.
_______________
PRODUCT Product Information No. P21177 - Rev. 06 of
the BBL Quality Control and Product
Information manual for Mueller Hinton Agar
with 5% Sheep Blood, an enriched prepared
plated medium which are recommended for
testing Streptococcus pneumoniae with
oxacillin. Recall #Z-958/960-6.
CODE (a) Catalog No. 4321176 (Package of 20 100 x
15mm Style Prepared Plates);
(b) Catalog No. 4321993 (Package of 8 150 x
15mm Style Prepared);
(c) Catalog No. 4321801 (Package of 24 150 x
15mm Style Prepared).
MANUFACTURER Becton Dickinson Microbiology Systems,
Cockeysville, Maryland.
RECALLED BY Manufacturer, by letter on March 8, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 7,689 copies of PI No. 21177 - Rev. 06 were
distributed.
REASON Devices were marketed without an approved
premarket notification submission (510(k)) for
use in the susceptibility test of S.
pneumoniae as indicated in Product Information
No. P21177 - Rev. 06 of the BBL Quality
Control and Product Information Manual, dated
July 1994.
-9- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Columbia CNA Agar with 5% Sheep Blood, for in-
vitro diagnostic use for the isolation and
differentiation of gram-positive
microorganisms from clinical and nonclinical
specimens: (a) Package of 20 Plates, Catalog
No. 4321352; (b) Package of 100 Plates,
Catalog No. 4321353. Recall #Z-951/952-6.
CODE (a) Lot No. C1RFTK; (b) Lot No. C1RFTK.
MANUFACTURER Becton Dickinson Microbiology Systems,
Cockeysville, Maryland.
RECALLED BY Manufacturer, by telephone on March 16, 1995,
followed by letter to anyone requesting it.
Firm-initiated recall complete.
DISTRIBUTION Nationwide, Singapore, Canada.
QUANTITY 199,000 plates were distributed; firm
estimates none remains on the market.
REASON The plates had hemolysis and cannot be used to
monitor differentiation.
_______________
PRODUCT BBL Brilliant Green Agar in 100 gram bottles,
a highly selective dehydrated culture medium
for isolation of salmonella other than S.
Typhi from feces and other materials.
Recall #Z-954-6.
CODE Catalog #12426, Lot #B6DBTS EXP 2/1/97.
MANUFACTURER Becton Dickinson Microbiology Systems (BDMS),
Cockeysville, Maryland.
RECALLED BY Manufacturer, by telephone August 1994. Firm-
initiated recall complete.
DISTRIBUTION Illinois, New Jersey, Texas.
QUANTITY 7 bottles were distributed; firm estimates
none remains on the market.
REASON The product was mislabeled as Brilliant Green
Bile Agar.
_______________
PRODUCT CMVscan Latex Agglutination Test, 500 or 30
qualitative tests, a passive latex
agglutination assay for detection of
antibodies to cytomegalovirus (CMV):
(a) Catalog #4955126, 30 Test Kit; (b) Catalog
#4955201, 500 Test Kit. Recall #Z-955/956-6.
CODE Lot numbers: (a) C6FFMF; (b) C6FFNH.
MANUFACTURER Becton Dickinson Microbiology Systems,
Cockeysville, Maryland.
RECALLED BY Manufacturer, by letter on May 13, 1996,
followed by telephone. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and Canada.
-10- QUANTITY (a) 70 kits; (b) 92 kits were distributed.
REASON An outdated package insert was shipped with
these two lots. The old insert lacks a
quality control procedure for donor screening.
-11-
END OF ENFORCEMENT REPORT FOR JULY 17, 1996. BLANK PAGES MAY FOLLOW.
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