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
10/09/1990
FDA Enforcement for the week of October 10, 1990
FDA ENFORCEMENT REPORT
FOR OCTOBER 10, 1990
October 10, 1990
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
Product: Fresh and frozen Albacore Tuna Salad in 12 ounce and 5
pound containers under the following labels: Shurfresh,
Ozark Farms; R.B. Rice and Priddys. Recall #F-595-0.
Code: R.B. Rice and Shurfresh (5 pound) - APR 22 1990;
R.B. Rice and Priddys (12 ounce) - May 3, 1990;
Ozark Farms (5 pound) (frozen) - 0153-0.
Manufacturer: Ozark Salad Company, Baxter Springs, Kansas.
Recalled by: Manufacturer, by telephone followed by letter
April 16, 1990. Firm-initiated recall complete.
Distribution: Colorado, Illinois, Kansas, Louisiana, Missouri,
Oklahoma, Texas.
Quantity: Firm estimates none remains on the market.
Reason: Product is contaminated with Listeria monocytogenes.
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-1-
Product: Mt. Olive brand Fresh Kosher Dill Pickles, in 1
gallon glass jars. Recall #F-609-0.
Code: Lot numbers: E1FE1829, F1FE1829, G1FE1829, H1FE1829.
Manufacturer: Mt. Olive Pickle Company, Mt. Olive, North Carolina.
Recalled by: Manufacturer, by telephone March 19, 1990 and by FAX
March 20, 1990. Firm-initiated recall ongoing.
Distribution: Maryland, Virginia, North Carolina, South Carolina,
Tennessee, Georgia, Florida.
Quantity: 2,919 cases (4 jars/case) were distributed.
Reason: Potential for Clostridium botulinum toxin hazard.
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Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
Product: Various prepared salads et al in 5, 15 and 30 pound
plastic containers:
(a) Banana Fluff
(b) Potato Salad
(c) Macaroni & Pea Salad
(d) Pistachio Fluff
(e) Deliteful Lemon. Recall #F-536, F-543/546-0.
Code: All products distributed since 5/12/90.
Manufacturer: Frank's Fruit House, Omaha, Nebraska.
Recalled by: Manufacturer, by affixing corrective sticker labels to
products June 9, 1990. Firm-initiated field correction
complete.
Distribution: Nebraska.
Quantity: Firm estimates none remains on the market.
Reason: Products contain undeclared FD&C Yellow No. 5.
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Product: Hand painted Chinese style porcelain plates, bowls,
coffee and tea sets, et al:
1. 6" ROUND SOUP BOWL
2. 6" ROUND PLATE
3. 9" BOWL
4. 8" PLATE
5. 7" PLATE
6. 4" PLATE
7. 6" PLATE
8. 8" ROUND PLATE
9. TEA CUPS & SAUCERS
10. 9" PLATE
11. 10" PLATE
12. 10" OVAL PLATE
13. 12" PLATE
14. 8" SOUP PLATE
-2-
15. 4" ROUND PLATE
16. CASSEROLE DISH
18. 4 1/2" BOWL
19. 6" BOWL
20. 7" BOWL
21. 8" BOWL
22. 12" BOWL
23. 16" BOWL
24. TEA SET
25. CUPS & SAUCERS
26. 7" ROUND PLATE
27. 10" ROUND PLATE
28. 9" Flat PLATE
29. COFFEE SET
30. 4" SAUCE DISH
31. 7" FLAT PLATE
32. DEMI-TASSE CUPS & SAUCERS
33. 9" SQUARE SCALLOP DEEP DISH
34. 10" ROUND SCALLOP DISH
35. 8" FLAT PLATE
36. 8" DEEP BOWL
37. 6" DEEP BOWL
38. 10" FLAT PLATE ASSORTMENT. Recall #F-603-0 and
F-616/651-0.
Code: Not coded.
Manufacturer: Unknown - Product of the People's Republic of China.
The Allion Company, Ltd., Hong Kong (shipper).
Recalled by: Nantucket Distributing Company, Inc., South Yarmouth,
Massachusetts, by telephone August 6, 1990. Firm-initiated
recall ongoing.
Distribution: Massachusetts, Rhode Island.
Quantity: 7,442 pieces were distributed.
Reason: Products contain excessive levels of leachable lead.
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Product: (a) Diet Coke, in 12 ounce cans, packed in 6 pack
cases; (b) Sprite, in 12 ounce cans, packed in 20
can packages. Recall #F-605/606-0.
Code: (a) 6/11/90; (b) Not coded.
Manufacturer: Coca Cola Bottling Company, Maspeth, New York.
Recalled by: Manufacturer, by letter July 13, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates 4,000 cases remain on market.
Reason: Product is contaminated with Dicolube PL, a conveyor
lubricant.
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Product: Fresh Lemons from Spain, packed in wooden crates,
90 and 100 count each. Recall #F-612-0.
Code: Not coded.
-3-
Manufacturer: Terres Noires Ltd., Sherrington, Quebec (shipper).
Recalled by: A.N. Deringer, Inc., Champlain, New York, by telephone
February 9, 1990. Firm-initiated recall complete.
Distribution: New York.
Quantity: 832 cartons were distributed; firm estimates none
remains on market.
Reason: Product contains the non-permitted pesticide Mecarbam.
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Product: Grapefruit-Shaped Yellow Ceramic Bowl 4" in diameter.
Recall #F-615-0.
Code: Product identification number 554-939.
Manufacturer: Kabushiki Kaisha Kyeui Shokai and Sankyo Togyo, Japan.
Recalled by: Pier 1 Imports, Fort Worth, Texas (importer), by
electronic mail May 17, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide, Canada.
Quantity: 20,088 pieces were distributed; firm estimates 18,215
pieces have been returned.
Reason: Product contains excessive levels of leachable lead.
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Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Various prepared salads et al, in 5, 15 and 30 pound
plastic containers:
1. Shrimp Salad
2. Imitation Crab Salad
3. Shell Macaroni Salad
4. Mushroom Salad
5. Waldorf salad
6. Kidney Bean Salad
7. Sweet Kraut
8. Carrot & Raisin Salad
9. Seafood Base
10. Pasta Mix
11. Tuna Salad
12. Country Potato Salad
13. Relish Potato Salad
14. Macaroni Salad
15. German Style Potato Salad
16. Creamy Cole Slaw
17. Mustard Style Potato Salad
18. Vegetable Salad
19. Mostaccioli Salad. Recall #F-547/565-0.
Code: All products distributed since 5/12/90.
-4-
Manufacturer: Frank's Fruit House, Omaha, Nebraska.
Recalled by: Manufacturer, by affixing corrective sticker labels to
products June 9, 1990. Firm-initiated field correction
complete.
Distribution: Nebraska.
Quantity: Firm estimates none remains on the market.
Reason: Products contain undeclared potassium sorbate.
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Product: Herb-Ox Instant Broth and Seasoning Low Sodium Beef
Flavor, in 1.1 ounce boxes. Recall #F-604-0.
Code: Lot #W89333A marked only on box and case units.
Manufacturer: Durkee-French Foods, Inc., Wolcot, New York.
Recalled by: Durkee-French Foods, Inc., Division of Reckitt &
Colman, Inc., Wayne, New Jersey, by letter March 5, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 891 cases (8 packets per box, 12 boxes per
case) were distributed; firm estimates 681 cases remain
on the market.
Reason: Sodium superpotency.
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Product: Logan Valley brand Peeled Hard Cooked Eggs, in 10
pound and 25 pound poly-lined plastic tubs.
Recall #F-607-0.
Code: Lot numbers: 186-0-1, 186-0-2.
Manufacturer: Milton G. Waldbaum Company, Wakefield, Nebraska.
Westbrook Egg Company, Westbrook, Minnesota (distributor).
Recalled by: Milton G. Waldbaum Company, by telephone July 27, 1990.
Firm-initiated field correction (relabeling) complete.
Distribution: Nevada.
Quantity: Firm estimates all units were corrected.
Reason: Product fails to have label state "Keep Refrigerated."
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Product: Unlabeled Frozen Orange Juice Concentrate in 55 gallon
drums. Recall #F-610-0.
Code: Not coded.
Manufacturer: Sun-Up Foods, Inc., Benton, Kentucky.
Recalled by: Manufacturer. Firm-initiated recall complete.
Distribution: Massachusetts, New Jersey, New York.
Quantity: Firm estimates none remains on market.
Reason: Product contains added beet juice medium invert
sugar and tangerine juice.
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-5-
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Recovered Plasma. Recall #B-218-0.
Code: Unit #54F46710.
Manufacturer: American Red Cross Services, Puerto Rico Region,
San Juan, Puerto Rico.
Recalled by: Manufacturer, by FAX June 2, 1989. Firm-initiated
recall complete.
Distribution: Switzerland.
Quantity: 1 unit was distributed and was destroyed.
Reason: Recovered Plasma from a donor with a history of
cancer was distributed.
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Class III -
Product: BiCNU brand of Carmustine, in 100 mg vial, Rx sterile
antineoplastic. Recall #D-404-0.
Code: Lot #LCC33.
Manufacturer: Ben Venue Laboratories, Bedford, Ohio.
Recalled by: Bristol-Myers Oncology Division, Evansville, Indiana,
by letter August 24, 1990. Firm-initiated recall ongoing.
Distribution: Massachusetts, Maine, Maryland, New Jersey, New York,
Pennsylvania, Virginia, Vermont, Washington, D.C.
Quantity: Thirteen 10-unit packs were distributed; firm estimates
very little of the product remains on the market.
Reason: 130 vials with United Kingdom labeling were mistakenly
distributed to United States consignees.
----
Product: Calciferol in Sesame Oil (Ergocalciferol) Injection 12.5 mg
(500,000 IU), in 1 ml ampuls, an Rx injectable
ergocalciferol product indicated for treatment of
hypoparathyroidism and refractory rickets
and labeled as distributed by Kremers Urban (Canada).
Recall #D-405-0.
Code: Lot numbers 13635, 13637, 13638.
Manufacturer: Kremers Urban Company, Mequon, Wisconsin.
Recalled by: Manufacturer, by letter May 7 & 10, 1990. Firm-initiated
field correction complete.
Distribution: Canada.
-6-
Quantity: 105 boxes (5 ampuls per box) were distributed; firm
estimates all units were corrected..
Reason: Error in potency statement on the package insert.
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Product: Monoclate-P Antihemophilic Factor (Human) Factor VIII.
Recall #B-220-0.
Code: Lot numbers: E32912, F34304, F34404, F35105, F33501.
Manufacturer: Burron Medical, Inc., Bethlehem, Pennsylvania.
Recalled by: Armour Pharmaceutical Company, Kankakee, Illinois,
by letter July 18 and 23, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide.
Quantity: 5,831 kits were distributed; firm estimates 2,400
remain on market.
Reason: Antihemophilic factor kits, possibly containing
misbranded administration components for intravenous
infusion, were distributed.
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MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: CT Scanner Systems (a) Model No. SCT-2000T-11;
(b) Model SCT-3000TE; (c) Model SCT-3000TF;
(d) Model SCT-3000TX. Recall #Z-916/919-0.
Code: Serial numbers: None indicated.
Manufacturer: Shimadzu Medical Systems, Gardena, California.
Recalled by: Manufacturer FDA approved the firm's corrective action plan
July 26, 1990. Firm-initiated field correction
ongoing.
Distribution: Nationwide
Quantity: 62 units were distributed.
Reason: Noncompliance with performance standards for diagnostic
x-ray products in that indicator lamps were inadequate
and CTDI values and specification for the accuracy of KVP
needed revision.
----
Product: Ivion Intelliject Stream Switch Manifold, sterile devices
used as a component of Ivion's Intelliject Multi-Channel
Infusion Pump, for the delivery of IV drugs to the patient.
(a) Quad IV Administration Line, 4-inlet, catalog #2003;
(b) Dual IV administration Line, 2-inlet, catalog 2021.
Recall #Z-920/921-0.
Code: All lots manufactured with May and June 1990 date codes.
Manufacturer: Ivion Corporation, Broomfield, Colorado.
-7-
Recalled by: Ivion Corporation, Englewood, Colorado, by telephone
August 8, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 475 cases (12 units/case) were distributed.
Reason: The manifold may break between the luer and the manifold
body or leaks may occur at other parts of the manifold
body.
----
Product: Ivion Volumetric Infusion Pumps, used to control
preset volume, and flow rate of intravenous fluids
to patients, and will also display amount infused:
(a) Model EZ-1; (b) Model KIDS. Recall #Z-922/923-0.
Code: All serial numbers.
Manufacturer Ivion Corporation, Broomfield, Colorado.
Recalled by: Manufacturer, by letter August 9, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 430 pumps were distributed.
Reason: The valve actuator inside the infusion pump may become
dislodged from the pivot plate when the IV set cassette
is inserted in or removed from the pump.
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Product: Ohmeda GMS Absorber Check Value Disk Retainers:
(a) Stock #0219-1338-300;
(b) Stock #1400-8007 000;
(c) Stock #0210-5297-100. Recall #Z-924/926-0.
Code: All Ohmeda GMS Absorbers that begin with the following
Alpha serial number characters are involved: ACLL;
ACLM; ACLN; ACLP, ACLQ; ACLR; ACLS. In addition,
serial numbers ACLT00001 through ACLT01819.
Manufacturer: Ohmeda, Madison, Wisconsin.
Recalled by: Manufacturer, by letters of August 7, 1990, and
September 7, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 14,387 absorbers were distributed.
Reason: The design of the replacement retainer check valve disks
may cause the inhalation or exhalation check valves to
stick in an open position.
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Class III -
Product: Sechrist Air-Oxygen Mixers, pressure regulated and
proportioning devices, designed to mix medical breathing
air and oxygen for delivery to a variety of respiratory care
equipment:
(a) Model 3500HL;
(b) Model 3600 (pole mount);
(c) Model 3601 (wall mount). Recall #Z-927/929-0.
-8-
Code: Serial numbers are 21758 through 21777, 21786, 21787,
21789, 21794 through 21795, 21803 through 21850,
21860 through 21862, 21876 through 21890.
Manufacturer: Sechrist Industries, Inc., Anaheim, California.
Recalled by: Manufacturer, by telephone April 25, 1990 followed by
letter April 26, 1990. Firm-initiated recall ongoing.
Distribution: California, Indiana, Massachusetts, Michigan, Minnesota,
New Jersey, Ohio, Utah, Belgium, Canada, France, Italy,
Spain.
Quantity: 91 units were distributed.
Reason: The tolerance and the air/oxygen concentrations set on
the device may not be the same as that being delivered
to the patient.
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VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Glover's Everyday brand (700) Anaplasmosis Range Block
(medicated), for ruminants only, containing Chlortetracyline
700 mg/lb., labeled as an aid in the prevention of
anaplasmosis; as an aid in the prevention of bacterial
pneumonia and shipping fever (hemorrhagic septicemia);
and as an aid in the reduction of losses due to respiratory
infections (infectious rhinotracheitis-shipping fever).
Recall #V-059-0.
Code: All lots.
Manufacturer: Glover Feed Mills, Inc., Mt. Pleasant, Texas.
Recalled by: Manufacturer, by visit September 5, 1990. Firm-initiated
recall ongoing.
Distribution: Texas.
Quantity: 9,900 33-1/3 pound blocks were distributed.
Reason: The product is a new animal drug being marketed without
an approved New Animal Drug Application.
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Product: (a) Square Deal brand Swine-60 Vitamin Mineral Premix,
in 60 pound bags;
(b) Bey-Agri Services Ade-TM Pak Vitamin Mineral Premix
in 50 pound bags;
(c) Andrews University brand Lact Cow Vitamin Mineral
Premix, in 50 pound bags. Recall #V-060/062-0.
Code: Lot #204190.
Manufacturer: Heinold Feeds, Inc., Kouts, Indiana.
Recalled by: Manufacturer, by telephone between July 26 and 28,
1990. Firm-initiated recall ongoing.
Distribution: Indiana, Ohio, Illinois, Michigan.
-9-
Quantity: (a) 330 bags; (b) 84 bags; (c) 121 bags were distributed;
firm estimates none remains on market.
Reason: Superpotent selenium content.
Class III -
NONE
Seizure Actions Filed:
Product: Latex Examination Gloves (89-455-605).
Charge: Quality falls below that which it purports or
represents to possess because article contains holes.
Firm: Voit Sports, Sparke, Nevada.
Filed: December 14, 1989 - U.S. District Court for the District
of Nevada; Civil #CV-N-89-791-BRT, FDC #65789.
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Product: Antiseptics and other articles of drugs (90-471-774 et al).
Charge: Products are new drugs without approved new drug
applications. Also misbranded -- labeling is false
and misleading and fails to bear adequate directions
for use.
Firm: Vital Force, Inc., Ithaca, New York.
Filed: September 7, 1990 - U.S. District Court for the Northern
District of New York; Civil #90 CV 986; FDC #65892.
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Product: Various Drugs (90-544-792).
Charge: Adulterated - The methods used in, and the facilities and
controls used for their processing, packing and holding did
not conform to and were not operated and administered in
conformity with current good manufacturing practice
regulations.
Firm: Consolidated Midland Corporation, Brewster, New York.
Filed: September 6, 1990 - U.S. District Court for the Southern
District of New York; Civil #90-CIV-5747, FDC #65909.