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
05/17/1995
ENFORCEMENT REPORT FOR 05 17 95
May 17, 1995 95-20
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Gulliver Wafer Bar coated with chocolate, sold in 5-pound
cartons. Recall #F-653-5.
CODE None.
MANUFACTURER Golden Chocolate Company, Brooklyn, New York (finished
product).
RECALLED BY Manufacturer, by telephone April 11, 1995, followed by
letter April 12, 1995. Firm-initiated recall ongoing.
DISTRIBUTION New York, California, Connecticut, Illinois, Maryland,
Massachusetts, Michigan, Minnesota, New Jersey, Ohio,
Pennsylvania, Rhode Island, Texas, Utah, Washington state,
Wisconsin, Washington, D.C.
QUANTITY Approximately 40 5-pound cartons were distributed.
REASON The product contains undeclared hazelnut paste.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Snapple Diet Lemon Flavored Iced Tea, real brewed natural
iced tea, in 16 fluid ounce glass bottles.
Recall #F-650-5.
CODE Cap code - CT626 DLT/0446 (XX:XX) where XX:XX = 21:58/22:30;
Case code - K Diet Lemon Tea 16376/CT62602136 (XX:XX) where
XX:XX = 21:58/22:30.
MANUFACTURER Beverage Capital, Baltimore, Maryland.
RECALLED BY Snapple Beverage Corporation, East Meadow, New York, by
telephone, followed by letter March 31, 1995. Firm-
initiated recall complete.
DISTRIBUTION Kentucky, Connecticut, Pennsylvania, New Jersey, Maryland,
Delaware, Virginia, Minnesota, Vermont, New York, Alabama,
Massachusetts, North Carolina, North Dakota, Wisconsin,
Ohio, Tennessee.
QUANTITY 25,902 cases (24 bottles per case were distributed).
REASON The diet lemon flavored iced tea actually contains peach
flavored iced tea which contains high fructose corn syrup.
_______________
PRODUCT (a) Lily Mantcadas, Vanilla Cake, 6 pack, 8 ounces; (b) Lily
Cup Cake, 6 pack, 4 ounces. Recall #F-651/652-5.
CODE All product failing to declare FDC Yellow #5 on label.
MANUFACTURER Lily Bakery, Miami, Florida.
RECALLED BY Manufacturer, by placing stickers on the front of packages
declaring FDC Yellow #5 on packages beginning February 2,
1995. Firm-initiated field correction (relabeling)
complete.
DISTRIBUTION New York, New Jersey, Florida.
QUANTITY Firm estimates none remains on the market.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Blackeyed Pate in 11.5 ounce glass jars, a blackeyed pea
dip. Recall #F-654-5.
CODE All lots manufactured prior to December 23, 1994.
MANUFACTURER Willie B's, Inc., Rockwall, Texas.
RECALLED BY Manufacturer, by telephone January 30 and 31, 1995, followed
by letter February 22, 1995. Firm-initiated recall
complete.
DISTRIBUTION Georgia.
QUANTITY 10,944 jars were distributed; firm estimates none remains on
the market.
REASON Product is in leaking containers and has the potential to
support the outgrowth of Clostridium botulinum toxin but he
probability of such growth is remote.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Cool Whip Non-Dairy Whipped Topping, in 12 ounce tubs.
Recall #F-645-5.
CODE Tub code - 5093W; Case code - 3 APR 95W XX:XX ZZ 5 (where
XX:XX = military time 07:00 to 23:59 and ZZ = 1 to 12.
MANUFACTURER Dean Foods Vegetable Company, Waseca, Minnesota.
RECALLED BY Kraft Foods, Inc., Northfield, Illinois, by fax April 14,
1995. Firm-initiated recall complete.
DISTRIBUTION Kansas, Louisiana, Texas, California, Minnesota, Oregon,
Iowa.
QUANTITY 1,848 cases (12 tubs per case) were distributed.
REASON Product may contain small pieces of plastic or nylon scraper
blade.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Colistin Sulfate USP, for prescription compounding.
Recall #D-162-5.
CODE Lot 5B6204 EXP 1/97.
MANUFACTURER Paddock Laboratories, Inc., Minneapolis, Minnesota
(recaller/relabeler).
RECALLED BY Relabeler, by telephone April 19, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION California, Illinois, Ohio, Missouri, New York, North
Carolina.
QUANTITY 17 bottles were distributed.
REASON Potency is mislabeled. Correct potency is 700 mcg/mg, 21000
units per mg. Label declares it in reverse.
_______________
PRODUCT Dilantin Kapseals (extended Phenytoin Sodium Capsules) 30
mg, in bottles of 100, Rx antiepileptic drug.
Recall #D-168-5.
CODE Lot #52264L EXP 7/96.
MANUFACTURER Warner-Lambert Company, Lititz, Pennsylvania.
RECALLED BY Manufacturer, by letter dated April 20, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 30,964 bottles were distributed.
REASON Product does not meet dissolution specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Isoniazid: (a) 100 mg, in bottles of 100; (b) 300 mg in
bottles of 30, used in the treatment of tuberculosis.
Recall #D-160/161-5.
CODE Lot numbers: (a) 4A6094, 3L6967, 3F6585, 3B6257, 2L6017,
2J6876, 2E6585, 2B6355, 2J6875, 1E6671, 1K6058; (b) 1H6964,
1G6858, 1H6966, 1H6965, 1K6072, 1K6066, 1B6410, 1G6831,
1A6245, 0H6737, 0K6959.
MANUFACTURER Barr Laboratories, Inc., Pomona, New York.
RECALLED BY Paddock Laboratories, Inc., Minneapolis, Minnesota
(repacker), by letter April 25, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 13,248 bottles of 100 mg tablets and 42,037 bottles of 300
mg tablets were distributed; firm estimated that 200 bottles
of the 100 mg tablets and no bottles of the 300 mg tablets
remained on market at time of recall initiation.
REASON Products do not meet dissolution specifications at the 48
and 60 month test intervals.
_______________
PRODUCT Unipen Injection (Nafcillin Sodium), sterile powder,
packaged in 10 gram vials. Recall #D-163-5.
CODE Lot #2940267 EXP 10/97.
MANUFACTURER Wyeth Ayerst Laboratories, West Chester, Pennsylvania.
RECALLED BY Manufacturer, by letter dated April 17, 1995 Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 272 packages of 10 were distributed.
REASON Presence of glass particles.
_______________
PRODUCT Hydrocortisone Powder USP, micronized, non-sterile, in 25
gram bottles, used for prescription compounding.
Recall #D-164-5.
CODE Lot #5B6162.
MANUFACTURER Paddock Laboratories, Inc., Minneapolis, Minnesota
(repacker/relabeler).
RECALLED BY Repacker, by letter April 27, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,927 bottles were distributed.
REASON Some bottles of 25 grams powder are mislabeled as 10 grams.
_______________
PRODUCT Nitrostat Sublingual Tablets (Nitroglycerin Tablets, USP), a
vasodilating agent indicated for the prophylaxis, treatment
and management of patients with angina:
(a) 0.15 mg in bottles of 25 and 100 tablets;
(b) 0.6 mg in bottles of 100. Recall #D-165/166-5.
CODE (a) 09030F, 09030FA, 00170F, 00170FA; (b) 13060F, 13160F.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke Davis, Division of Warner Lambert Company, Morris
Plains, New Jersey, by letter mailed between March 13 and
15, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 120,618 units were distributed.
REASON Products may not meet content uniformity specifications.
______________
PRODUCT Sulfacet-R Lotion (Sodium Sulfacetamide 10%, Sulfur 5%) 8 ml
samples, packaged in cartons of 12 bottles, under the Dermik
Laboratories label. Recall #D-167-5.
CODE Lot numbers: 98423 EXP 6/95, 98631 EXP 8/95, 98888 10/95.
MANUFACTURER Dermik Laboratories, Inc., Collegeville, Pennsylvania.
RECALLED BY Manufacturer, by telephone February 16, 1995, followed by
letter dated February 24, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,427 of lot 98423, 5,598 of lot 98631, 5,436 of lot 98888
bottles were distributed.
REASON Non-uniformity of the sulfur ingredient.
_______________
PRODUCT X-Prep Bowel Evacuant Kits:
(a) X-Prep Bowel Evacuant Kit-1, labeled in part Contents:
X-Prep Liquid *** 2 Senokot-S Tablets *** 1 Rectolax
Suppository *** Distributed by Gray Pharmaceuticals Co.***",
for preparation of the colon for x-ray, endoscopic
examination or for surgery;
(b) X-Prep Kit-2 Bowel Evacuant for Barium Enema, labeled in
part "X-Prep Kit 2 Bowel Evacuant for Barium Enema with ***
Citralax Granules and Rectolax Suppository *** Distributed
by Gray Pharmaceutical Co.", for cleansing of the colon
prior to x-ray, endoscopic examination, or surgery.
Recall #D-169/170-5.
CODE Lot numbers: (a) 5BV, 6ET; (b) 4YL, 6GS.
MANUFACTURER Clay-Park Labs, Inc., Bronx, New York (Bisacodyl 10 mg
Suppository).
RECALLED BY Gray Pharmaceutical, Company, Norwalk, Connecticut, by
letter May 3, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 37,577 kits of lot 5BV and 26,174 kits of lot 6ET; (b)
29,495 kits of lot 4YL and 20,164 kits of lot 6GS were
distributed.
REASON Subpotency of the bisacodyl suppository component.
_______________
PRODUCT Acetaminophen 325 mg Tablets, packaged in various size
blister packs, under the Vangard and Glasgow labels.
Recall #D-171-5.
CODE Lot numbers: 0591-100 EXP 11/96 (Vangard), 100-001 EXP 8/95
and 100-002 EXP 2/96 (Glasgow).
MANUFACTURER OHM Laboratories, Inc., Franklin Park, New Jersey.
RECALLED BY Vangard Labs, Inc., Glasgow, Kentucky, by letter May 1,
1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 926 cases containing 557,000 tablets were distributed.
REASON Product did not meet dissolution specifications through the
expiration date.
_______________
UPDATE Recall #D-110-5, Supac Analgesic Tablets, white uncoated
tablets in 100 and 1,000 count bottles, manufactured by
Mission Pharmacal Company, San Antonio, Texas, which
appeared in the April 12, 1995 Enforcement Report, has been
extended to include 7 additional lots -- 3H39, 4A36, 4E18,
080795, 360995, 420396, 490495.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
========================
_______________
UPDATE Recall #Z-1277-4, Matrx LifeDefense Plus (LDP) Portable
Defibrillator/Monitor/Pacer, which appeared in the October
5, 1994 Enforcement Report, is being extended to include the
following serial numbers: 0035, 0060, 0071, 0075, 0090,
0152, 0188, 0197, 0200, 0203, 0204, 0219, 0246, 0275, 0319,
0428, 0742, 0798, 0842.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Mevatron Linear Accelerators, used in the production of
therapeutic doses of radiation for the treatment of cancer:
(a) Conventional MEVATRON linear accelerators, models 20, K,
KD, MD and MXE;
(b) Digital MX2 MEVATRON linear accelerators; and
(c) Digital MEVATRON linear accelerators (other than MX2),
models KD2, KDS2, KX2, MD2, MDX2 and MXE2.
Recall #Z-339/341-5.
CODE Various serial numbers.
MANUFACTURER Siemens Medical Systems, Inc., Oncology Care Systems,
Concord, California.
RECALLED BY Manufacturer, by letter May 13, 1994. Firm-initiated field
correction complete.
DISTRIBUTION (a) Nationwide and international; (b) Florida, Ohio,
Mississippi, North Dakota, Ohio, and international; (c)
Nationwide and international.
QUANTITY (a) 606 units; (b) 18 units; (c) 204 units were distributed.
REASON (a) During patient positioning, there is a possibility
that the field-defining light mirror may not move into its
proper position. This could potentially result in improper
patient positioning and treatment;
(b) Possibility exists by which operator could insert an
accessory into the accessory holder without achieving proper
latching. An improperly latched accessory could fall out
and cause injury during setup;
(c) Subject to both problems as outlined in (a) and (b)
above.
_______________
PRODUCT Hanks' Balanced Salt Solution (HBSS), for in-vitro
diagnostic use. Recall #Z-710-5.
CODE Catalog numbers: 14175-012 (100 ml), 14175-020 (500 ml),
lot #17N2041 EXP 12/30/96.
MANUFACTURER Life Technologies, Inc., Grand Island, New York
RECALLED BY Manufacturer, by telephone November 18, 1994, and by letter
February 16, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,981 100-ml units and 1,798 500-ml units were distributed.
REASON Possible bacterial contamination.
_______________
PRODUCT Endo-Spor Hospital Type Disinfectant, in 1 gallon plastic
jugs. Recall #Z-720-5.
CODE Lot numbers: 924, 1638, 1723, 1939.
MANUFACTURER Globe Medical, Largo, Florida.
RECALLED BY Manufacturer, by letter June 14 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that as of June 13, 1994 about 3,000 gallons
remained on market.
REASON Incorrect grade of hydrogen peroxide was used in
manufacturing product.
_______________
PRODUCT CADD-TPN Administration Set with Air Eliminating Filters:
(a) Model 21-7014 (0.2 micron filter); (b) Model 21-7015
(1.2 micron filter). Recall #Z-727/728-5.
CODE Lot numbers: (a) 30705 and higher; (b) 30699 and higher.
MANUFACTURER Sims Deltec, Inc., St. Paul, Minnesota.
RECALLED BY Manufacturer, by letter dated March 17, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, New Zealand, Switzerland, South Africa,
Singapore.
QUANTITY (a) 112,455 sets; (b) 246,315 sets.
REASON Air eliminating filters were found to be torn and or
ruptured, and failed to function as labeled.
_______________
PRODUCT Acuity Central Workstation Patient Monitoring System
Software, Version 3.00.00. Recall #Z-730-5.
CODE Version/release number 3.00.00 (replacement is 3.00.01).
Serial numbers: TA00231, TA00261, TA00341, TA00348.
TA00356, TA00357, TA00359, TA00382, TA00383, TA00389,
TA00390, and two non-serialized beta site copies. Also,
four sites were installed with the new version (not software
patched). The serial numbers are: TA00384, TA00385,
TA00386, TA00387. 3 clinical machines at the manufacturing
facility -- serial numbers: CLIN1, CLIN2, CLIN3.
MANUFACTURER Protocol Systems, Inc., Beaverton, Oregon.
RECALLED BY Manufacturer, by telephone or by letter to arrange for
installation of upgrade. The upgrades began on February 21,
1995. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 17 systems in commerce and 3 clinical systems at the
manufacturing facility.
REASON If a user attempts to retrieve patient data between 24 and
24.5 hours after the patient has been disconnected, the
device may reboot, thus causing a short period of time when
connected patients cannot be centrally monitored.
_______________
PRODUCT Drake Willock System 1000 Delivery System for Single Patient
Hemodialysis. Recall #Z-731-5.
-7- CODE Various serial numbers.
MANUFACTURER Althin Medical, Inc., Portland, Oregon.
RECALLED BY Manufacturer, by update mailed beginning March 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Over 4,000 units were distributed.
REASON The pump head is cutting or abrading the blood tubing
causing blood leaks.
_______________
PRODUCT Drake Willock System 1000 Single Patient Delivery System
with Heparin Option for Single Patient Hemodialysis.
Recall #Z-732-5.
CODE Serial numbers 1001 to 3873.
MANUFACTURER Althin Medical, Inc., Portland, Oregon.
RECALLED BY Manufacturer, by letter March 6, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON The heparin pump does not deliver a bolus under certain
conditions.
_______________
PRODUCT T-9 SCOOP Transtracheal Procedure Tray. Recall #Z-733-5.
CODE Lot Numbers: 900801, 901005, 910205, 910304, 910403,
910404, 910503, 910602, 910603, 910701, 910704, 910805,
910904, 911102, 911103, 911201, 911203, 920101, 920103,
920203, 920203X, 920303, 920304, 920403, 920404, 920502,
920503, 920603, 920801, 920904, 920905, 921003, 921004,
921101, 921203, 930102, 930203, 930302, 930303, 930404,
930504, 930604, 930702, 93X801, 930901, 930903, 931001,
931002, 931203, 931204, 940301, 940302, 940307, 940502,
940602, 940605, 940802, and 940905.
MANUFACTURER Transtracheal Systems, Inc., Englewood, Colorado.
RECALLED BY Manufacturer, by letter January 9, 1995. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide, England, The Netherlands, Canada, Belgium,
Norway, Germany.
QUANTITY 4,519 trays were distributed; firm estimated that 200 trays
remained on market at time of recall initiation.
REASON The marking pen on the sterile Procedure Tray had been
evaluated on an earlier Ethylene Oxide Comparative
Resistance Study and was found "unable to sterilize".
_______________
PRODUCT EdenTec Model 4185 Safety Locking Patient Cables, Part #241-
3238, an accessory to the Model 2000 infant apnea monitor.
Recall #Z-741-5.
CODE Lot #36178.
MANUFACTURER CEA Technologies, Colorado Springs, Colorado.
RECALLED BY EdenTec Corporation, Eden Prairie, Minnesota, by letter
March 21, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 201 cables.
REASON A high impedance electrical short in the apnea monitor
patient cable could cause the monitor to fail to alarm
during an apnea event.
_______________
PRODUCT Ophthalmic Laser System, for use in ophthalmic surgery -
posterior capsulotomies. Recall #Z-742-5.
CODE Model 2500/2500LE.
MANUFACTURER Alcon Surgical, Inc., Irvine, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan April 25, 1995. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 291 units were distributed.
REASON Devices that have 200/210 software version were found to
have a defective software design in that a higher than
expected output energy may result if a wire becomes
disconnected.
_______________
UPDATE Recall #Z-697-5 Roentgenography Sets, which appeared in the
May 10, 1995 Enforcement Report, should read:
MANUFACTURER: Becton Dickinson and Company, Franklin Lakes,
New Jersey.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Cell Culture Media, for in-vitro diagnostic use:
(a) Dulbecco's Modified Eagle Medium, Catalog No. 12320-024;
(b) Dulbecco's Modified Eagle Medium, Catalog No. 11960-010;
(c) BGJ Medium, Catalog Nos. 12591-020 and 12591-012;
(d) KaryoMax Colcemid Solution, Catalog No. 15210-016;
(e) RPMI Medium 1640, Catalog No. 11875-069;
(f) RPMI Medium 1640, Catalog No. 11876-018;
(g) RPMI Medium 1640, Catalog No. 11875-051;
(h) Minimum Essential Medium D-Valine;
Catalog No. 12570-024;
(i) Opti-Mem I, Catalog Nos. 31985-021, 31985-013.
Recall #Z-701/709-5.
CODE Lot numbers: (a) 23P5245; (b) 31K4342; (c) 13N1141;
(d) 13P6247; (e) 14P8542; (f) 29K2240; (g) 14K8041;
(h) 24N4043; (i) 21N9740 .
MANUFACTURER Life Technologies, Inc., Grand Island, New York.
RECALLED BY Manufacturer, by letters issued between February 22, 1995
and March 1, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 370 units; (b) 1,434 units; (c) 36 units (100 ml), 254
units (500 ml); (d) 954 units; (e) 884 units; (f) 219 units;
(g) 3,767 units; (h) 366 units; (i) 501 units were
distributed.
REASON Possible bacterial contamination.
_______________
PRODUCT Bactec 12B Media, a Middlebrook 7H12 medium used for the
growth/detection, identification and susceptibility testing
of Mycobacteria spp., in the BACTEC 460TB System.
Recall #Z-737-5.
CODE Lot numbers: D4J4 through D4J14 EXP 11/1/95, E4J1 through
E4J14 EXP 12/1/95, FJ1 through FJ18 EXP 1/1/96, G4J1 through
G3J13 EXP 2/1/96, H4J1 through H4J17 EXP 3/1/96, J4J1
through J4J19 EXP 4/1/96, K4J1 through K4J8 EXP 5/1/96, L4J1
through L4J8 EXP 6/1/96, N4J1 through N4J3 EXP 7/1/96.
MANUFACTURER Becton Dickinson, Sparks, Maryland.
RECALLED BY Manufacturer, by letter March 9, 1995 Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Canada.
QUANTITY 33,934 cases were distributed; firm estimated that 17,000
cases remained on market at time of recall initiation.
REASON The Bacted 12B Media had a delay in the time to detect
various species of Mycobacteria from both patient samples
and quality control organisms. This may result in
inappropriate susceptibility testing results.
MEDICAL DEVICE SAFETY ALERTS:
===========================================
_______________
PRODUCT Ventak PRx AICD (Automatic Implantable Cardioverter
Defibrillators), Models 1700 and 1705.
Safety Alert #N-030/031-5.
CODE All serial numbers.
MANUFACTURER Guidant Corporation, Cardiac Pacemakers, St. Paul,
Minnesota.
ALERTED BY Manufacturer, by letter April 18, 1995.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 6,000 units.
REASON Safety alert letter reminds physicians that they should use
the Model 2850 programmer to interrogate the implanted
devices as the first and last step of every patient follow-
up procedure to verify desired device therapy status, and to
reinforce with patients the need to avoid exposure to strong
magnets and magnetic fields.
SEIZURES:
=================================================================
_______________
PRODUCT "The Stimulator" and associated labeling, including
instructional video tapes, instructional manuals,
testimonial packets, guarantees, and "Secrets of Health"
booklets (95-739-449). (The article delivers a high voltage
electrical spark and is promoted for pain relief (e.g.,
back/joint pain, carpal tunnel syndrome, muscle pain, stiff
or swollen joints, migraine headaches, stress headaches,
sciatica, abdominal pain, allergies, and menstrual cramps).
CHARGES Adulterated - The article is a class III device for which
there is no approved premarket approval application in
effect, nor does the article have an investigational device
exemption. Misbranded - The article was not included in a
required list, nor was a required notice or other
information respecting the device provided.
LOCATION Universal Management Services, Inc., Akron, Ohio.
FILED April 28, 1995; U.S. District Court for the Northern
District of Ohio, Eastern Division; Civ. #5-95-CV-959;
FDC #67076.
SEIZED May 4, 1995 - goods valued at approximately $1.3 million.
_______________
PRODUCT Frozen Lobster Tails (95-711-238).
CHARGE Adulterated - The article consists in whole or in part of
decomposed lobster tails.
LOCATION Preferred Freezer Services, Inc., Miami, Florida.
FILED March 27, 1995; U.S. District Court for the Southern
District of Florida; Civ. #95-616-CIV-UNGARO-BENAGES;
FDC #67075.
SEIZED April 4, 1995 - goods valued at approximately $30,000.
-11-
END OF ENFORCEMENT REPORT FOR MAY 17, 1995. BLANK PAGES MAY FOLLOW.
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