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.
December 4, 1996 96-49
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Various flavored ice cream as follows:
(a) Chocolate Marshmallow packed in pint
containers, half gallon cartons and 2 1/2
gallon tubs
(b) Heavenly Hash packed in half gallon
cartons and 2-1/2 gallon tubs
(c) Mint Chip packed in 2 1/2 gallon tubs.
Recall #F-113/115-7.
CODE None.
MANUFACTURER Mercer's Dairy, Inc., Boonville, New York.
RECALLED BY Manufacturer, by press release and letter on
October 17, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION New York.
QUANTITY Undetermined.
REASON The product's labels fail to declare allergens
that may pose a potential hazard to sensitive
individuals: (a) contains undeclared egg
albumen; (b) contains undeclared egg albumen
and peanuts; (c) contains undeclared egg
yolks.
RECALLS AND FIELD CORRECTIONS: FOODS CLASS II ==============
_______________
PRODUCT Various flavored dry seasonings.
Recall #F-079/112-7.
CODES 1. Frontier All-Purpose Seasoning, 16-oz. bag
and 400 oz. (25-lb. box) 6131, 6177, 6239
(after 5/10/96) 6239 (after 8/26/96)
2. Frontier Saltless All Purpose Seasoning,
6131, 6177 1.28-oz. glass bottle (after
5/10/96)
3. Canadian-labeled Frontier Saltless All
Purpose Seasoning, 1.28-oz. glass bottle 6131
(after 5/10/96)
4. Frontier Bouquet Garni, 16-oz. bag 6256
(after 9/12/96)
5. Frontier Cajun Seasoning, 16-oz. bag 6162,
6225, 6248 (after 6/10/96) and 400 oz. (25-lb.
box)
6. Oak Street Market Gourmet Cajun Seasoning,
2.08-oz. glass bottle 6173, 6225 (after
6/21/96)
7. Frontier Cheese & Italian Herb Seasoning,
16-oz. bag 6229 (after 8/16/96)
8. Frontier Wellspring Grocery Greek Lamb
Sausage, 3.5 oz. (6183)
9. Frontier Ground Gumbo File, 16-oz. bag
6208 (after 7/26/96)
10. Frontier Herbs de Provence, 16-oz. bag
6220, 6255 (after 8/7/96) and 25-lb. box 6249,
6255 (after 9/5/96)
11. Canadian-labeled Frontier Non-Irradiated
Herbs de Provence, 0.8-oz. glass bottle 6220
(after 8/7/96)
12. Frontier Non-Irradiated Herbs de Provence,
0.8-oz. glass bottle 6220 (after 8/7/96)
13. Oak Street Market Gourmet Herbs de
Provence, 0.8-oz. glass bottle 6220 (after
8/7/96)
14. Whole Foods Herbs de Provence, 0.8 oz.
6220 (after 8/7/96)
15. International Seasonings Herbs de
Provence, 0.8-oz. glass bottle 6220 (after
8/7/96)
16. International Seasonings Herbs of Italy,
0.8-oz. glass bottle 6151, 6212 (after
5/30/96)
17. Frontier Ground Italian Seasoning, 16-oz.
bag 6187, 6221 (after 7/5/96)
18. Frontier Whole Italian Seasoning, 16-oz.
bag 6121, 6129, 6150, 6171, 6197, 6264 (after
4/30/96) and 25-lb. box
-2- 19. Frontier Non-Irradiated Italian Seasoning,
0.96-oz. foil pouches 6129 (after 5/8/96)
20. Frontier Saltless Italian Seasoning,
0.8-oz. glass bottle 6129, 6171, 6197 (after
5/8/96) and 1.04-oz. glass bottles 6176 (after
6/24/96)
21. Frontier Pizza Seasoning, 16-oz. bag 6155,
6162, 6184, 6198, 6240 (after 6/3/96) and
400-oz. (25-lb. box) 6162, 6184, 6198 (after
6/10/96)
22. Frontier Non-Irradiated Poultry Seasoning,
1.44-oz. glass bottle 6187, 6254 (after
7/5/96)
23. Canadian-labeled Frontier Non-Irradiated
Poultry Seasoning, 1.44-oz. glass bottle 6254
(after 9/10/96)
24. Frontier Ground Poultry Seasoning, 16-oz.
bag 6187 (after 7/5/96)
25. Oak Street Market Gourmet Poultry
Seasoning, 1.44-oz. glass bottle 6187, 6254
(after 7/5/96)
26. Whole Foods Poultry Seasoning, 1.44 oz.
6187 (after 7/5/96)
27. Frontier Cut & Sifted Thyme Leaf, 16-oz.
bag 6109, 6141, 6218 (after 4/18/96) and
25-lb. box 6141 (after 5/20/96)
28. Frontier Non-Irradiated Cut & Sifted Thyme
Leaf, 0.8-oz. foil pouches 6109, 6218, (after
4/18/96)
29. Canadian-labeled Frontier Non-Irradiated
Cut & Sifted Thyme Leaf, 0.64-oz. glass bottle
6109 (after 4/18/96)
30. Oak Street Market Gourmet Cut & Sifted
Thyme Leaf, 0.64-oz. glass bottle 6109, 6218,
(after 4/18/96)
31. Whole Foods Wild Spanish Thyme, 0.64 oz.
6109, 6218 (after 4/18/96)
32. Frontier Ground Thyme Leaf, 16-oz. bag
6129, 6190 (after 5/8/96)
33. Frontier Nettles Eyebright Formula Bulk
Herb Capsules, 300 Vegicaps (400 mg) in a foil
pouch 6185 (after 7/3/96)
34. Frontier Nettles Eyebright Formula 100
Vegicaps (400 mg) in a glass jar 6185 (after
7/3/96).
MANUFACTURER Frontier Cooperative Herbs, Norway, Iowa.
RECALLED BY Manufacturer, by telephone on October 4, 1996,
followed by letter on October 5, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Undetermined.
REASON Product is contaminated with Salmonella.
-3-_______________
PRODUCT Mercer's brand ice cream:
(a) Butter Brickle packed in 2 1/2 gallon tubs
(b) Pistachio packed in 2 1/2 gallon tubs.
Recall #F-116/117-7.
CODE None.
MANUFACTURER Mercer's Dairy, Inc., Boonville, New York.
RECALLED BY Manufacturer, by press release and letter on
October 17, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION New York.
QUANTITY Undetermined.
REASON Products contain undeclared almonds.
_______________
PRODUCT Quaker FrescAvena Oats Beverage Mix, Cinnamon
Flavor in 17.6 oz. (500g) plastic canisters 24
per case. Recall #F-121-7.
CODE Canister lot #10G6C7, Case Code JUL 10 96.
MANUFACTURER The Quaker Oats Co., Valencia, Venezuela.
RECALLED BY The Quaker Oats Company, Chicago, Illinois, by
telephone on September 26, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION New Jersey, New York, Connecticut,
Massachusetts.
QUANTITY 127 cases were distributed; firm estimated
that 30 percent of product remained on market
at time of recall initiation.
REASON Product is unfit for food due to the presence
of pieces of hot-melt adhesive.
_______________
PRODUCT Kellogg's Frosted Flakes, in 25 ounce boxes.
Recall #F-122-7.
CODE "Better If Used Before" date of "June 08, 1997
MA" printed on the boxtop.
MANUFACTURER Kellogg Company, Memphis, Tennessee.
RECALLED BY Kellogg Company, Battle Creek, Michigan, by
press release on August 6, 1996. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY Approximately 1,440 cases containing 16 boxes
each were in commerce at time of recall
initiation.
REASON Product contains undeclared almonds.
_______________
PRODUCT La Colonial Sweet Bread, packaged in 10 ounce
plastic bags. Recall #F-123-7.
CODE All lots.
MANUFACTURER La Colonial Bakery, Dallas, Texas.
-4-RECALLED BY Manufacturer, by visit on or about September
27, 1996. Firm-initiated field correction
(relabeling) complete.
DISTRIBUTION Texas.
QUANTITY 400 packages were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Minute Maid Apple Juice, in 9 pack and 8.45
ounce packages. Recall #F-120-7.
CODE Container Codes - JAN1997TE, JAN1997TF,
JAN1997TG, JAN1997TH; Case Code - Lot number
T30922F.
MANUFACTURER Coca Cola Foods, Paw Paw, Michigan.
RECALLED BY Coca Cola Foods, Houston, Texas, by visit on
June 3, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Iowa, Illinois, Indiana, Kansas, Kentucky,
Maryland, Michigan, Minnesota, Missouri,
Nebraska, Ohio, Virginia, Wisconsin, West
Virginia.
QUANTITY 12,772 cases were distributed.
REASON Product is unfit for food due to swells,
spoilage, and leaking containers.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT MPI MAA Kit, for the preparation of Technetium
Tc 99m Albumin Aggregated Injection, in
multidose vials containing 2.5 mg albumin
aggregated, 5.0 mg albumin human, 0.06 mg
stannous chloride, and 1.2 mg sodium chloride.
Recall #D-046-7.
CODE Lot numbers: V-1298 EXP OCT 04 96,
V-1381 EXP FEB 07 97, W-0069 EXP FEB 21 97
W-0289 EXP MAR 21 97.
MANUFACTURER Merck Frosst Canada, Inc., Quebec, Canada.
RECALLED BY Medi-Physics, Inc., an Amersham company,
Arlington Hts., Illinois (own label
distributor), by telephone on November 12,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Hong Kong.
QUANTITY 2,423 kits were distributed; firm estimated
that very little, if any, product remained on
market at time of recall initiation.
REASON Lack of adequate assurance of sterility of the
human albumin component manufactured by
Centeon, Kankakee, Illinois.
-5-RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Congess SR, packaged in bottles of 100, Rx
decongestant. Recall #D-047-7.
CODE Lot #6041479 EXP 2-97.
MANUFACTURER Fleming & Company, Fenton, Missouri.
RECALLED BY Manufacturer, by telephone on November 18,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 800 bottles were distributed.
REASON FDA analysis found this lot failed the release
rate test -- the 4th hour release interval for
Pseudoephedrine was found to be 90%; the
specification is not more than 88%.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-549/550-6.
CODE Unit #40FS03901.
MANUFACTURER American Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by letter dated October 3, 1995.
Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested initially reactive for
anti-HIV, units then tested into compliance
with no confirmatory test.
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-551/552-6.
CODE Unit #47C47842.
MANUFACTURER American Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by letter dated March 18, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois and Iowa.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested initially reactive for
anti-HIV, units then retested only once with
no confirmatory testing.
RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT Electric Mat Tables, Model SWM1-5E.
Recall #Z-131-7.
CODE Serial numbers: 0201-M4E-331-3,
0201-M5E-334-5, 0201-M3E-336
0212-M4E-337, 0212-M5E-338
0212-M3E-339.
-6-MANUFACTURER S & W Enterprises, Inc., Blaine, Minnesota.
RECALLED BY Manufacturer, by telephone on February 1,
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 9 mat tables were distributed.
REASON When the flexible coupler was used to move the
table up and down, the motor continued to run,
but the table height did not change.
_______________
PRODUCT Baxa Model 60001, Dual Rate Syringe Infusers,
used for the administration of IV drugs.
Recall #Z-132-7.
CODE Serial numbers: 2001 through 2089
2122 through 2181
2194 through 2264
2266 through 2365
2367 through 2438.
MANUFACTURER Baxa Corporation, Englewood, Colorado.
RECALLED BY Manufacturer, by telephone on August 23, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 392 units were distributed.
REASON The device has the potential to run at twice
the speed for which it is set.
_______________
PRODUCT EZ Flow 480 Ambulatory Infusion Pumps
containing software versions 2.2c or earlier.
Recall #Z-133-7.
CODE Various serial numbers with software version
2.2c or earlier.
MANUFACTURER Gish Biomedical, Inc., (formerly Creative
Medical Developments, Inc. (CMD)), Nevada
City, California.
RECALLED BY Manufacturer, by telephone on February 23,
1996 and March 1 and 18, 1996. Follow-up
letters were sent on June 11, 1996 and August
2, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 577 units were distributed.
REASON Due to a software error, the EZ-480 exhibits a
faulty infusion rate when placed in the pause
mode and subsequently restarts.
_______________
PRODUCT Devon Point of Use Cabinet: (a) Model Reorder
No. 4842; (b) Model Reorder No. 4844, an
accessory to the Devon Point of use Sharps-a-
Gator. Recall #Z-140/141-7.
CODE All lots.
-7-MANUFACTURER Graphic Controls (Devon Industries),
Chatsworth, California.
RECALLED BY Graphic Controls Corporation, Buffalo, New
York, by visit and by letters dated August 26,
1996, and September 4, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 10,840 cabinets; (b) 2,580 cabinets were
distributed.
REASON The solid color of the door of the sharps
container cabinet may affect the ability of
the user to determine the fill level of the
needles and syringes allowing for the
potential of needlestick injuries.
_______________
PRODUCT X-Ray Generator, Model No. CP700.
Recall #Z-142-7.
CODE All units.
MANUFACTURER Gendex-Del Medical Imaging Corporation,
Franklin Park, Illinois.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan on November 20, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Noncompliance with performance standards for
x-ray products in that selection of one of the
3,072 possible selectable exposure conditions
failed to meet the firm's accuracy claim for
mAs selection.
_______________
PRODUCT Stainless Steel Greenfield Vena Cava Filter
with 12 French Introducer System, a
permanently implanted device designed to
protect against pulmonary embolism while
maintaining patency of the vena cava.
Recall #Z-146-7.
CODE Catalog #50-400. All lots.
MANUFACTURER Boston Scientific Corporation, Watertown,
Massachusetts.
RECALLED BY Boston Scientific Corporation, Natick,
Massachusetts, by letters on April 29, 1996,
and October 26, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 4,898 devices were distributed.
REASON The guidewire can become wedged in the apex of
the vena cava filter using the jugular
approach.
-8-_______________
PRODUCT Opus Rubella Test Modules and Opus Rubella-M
Test Modules: (a) OPUS* Rubella Test Modules,
Catalog No. 464-050,
(b) OPUS* Rubella-M Test Modules (Foreign
Distribution), Catalog No. OWUX/25 and
OWUX/45. Recall #Z-148/149-7.
CODE Lot numbers: (a) Lot Nos. RBC6, RBC9, RBD3,
RBD4, RBD5, RBD6; (b) RMC8, RMC9.
MANUFACTURER Behring Diagnostics, Inc., Westwood,
Massachusetts.
RECALLED BY Manufacturer, by telephone on October 29,
1996, followed by letter. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Quantity estimated in distribution:
RBC6 5 boxes; RBC9 11 boxes
RBD3 13 boxes; RBD4 26 boxes
RBD5 39 boxes; RBD6 72 boxes
RMC8 2 boxes; RMC9 54 boxes.
REASON Negative control yielded indeterminate
results, and there was a high incidence of
false positive test results.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Condylar Bone Screws, Catalog #CS027-08/10.
Recall #Z-145-7.
CODE Lot #2076.
MANUFACTURER Komet Medical, Savannah, Georgia (supplier of
screws).
RECALLED BY TMJ Implants, Inc., Golden, Colorado, by
telephone, followed by letter sent by fax on
October 7, 1996. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania, Tennessee, Texas.
QUANTITY 8 packages of 7 screws each were distributed.
REASON Some Condylar Bone Screws were in packages
labeled as Fossa-Eminence Bone Screws, and
some Fossa-Eminence Bone Screws were
incorrectly labeled as Condylar Bone Screws.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III ======
_______________
PRODUCT Steward Custom Mix Calf Feed - Medicated in 50
pound bags (amprolium and rabon).
Recall #V-022-7.
CODE Product Code: 3447-12, Lot numbers J207 and
J249.
MANUFACTURER Cargill, Inc., Nutrena Feed Division, Memphis,
Tennessee.
-9-RECALLED BY Cargill Feed Division, Wayzata, Minnesota, by
telephone on September 16, 1996. Firm-
initiated recall complete.
DISTRIBUTION Mississippi.
QUANTITY 540 bags were distributed.
REASON Product was subpotent in amprolium/rabon.
-10-
END OF ENFORCEMENT REPORT FOR DECEMBER 4, 1996. BLANK PAGES MAY FOLLOW.
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End of Enforcement Report for
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