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
06/01/1994
Recalls and Field Corrections: Foods -- Class I -- 06/01/1994
June 1, 1994 94-22
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Keebler Fudge Shoppe Fudge 'n Caramel Shortbread Cookies, 11
ounces. Recall #F-403-4.
CODE Lot #L261.
MANUFACTURER Emerald Industries, Inc., Florence, Kentucky.
RECALLED BY Keebler Company, Elmhurst, Illinois, by issuing press
release on March 1, 1994, and by letter March 2, 1994.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 2,686 cases (12 packages per case) were distributed.
REASON Product contains peanuts or peanut containing ingredients
which are not declared on the label.
_______________
PRODUCT Smoked Salmon, in chunks of various sizes. Recall #F-407-4.
CODE None.
MANUFACTURER Multiple Products, Inc., doing business as The Fish Outlet,
Bow, Washington.
RECALLED BY Manufacturer, by letter February 10, 1994, and by telephone
February 17, 1994. Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY Approximately 300 pounds.
REASON Product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Seafood salads: (a) Diamond Island Maine Lobster Salad, in
5 ounce and 2 pound plastic containers; (b) Diamond Island
Maine Shrimp Salad, in 5 ounce and 2 pound plastic
containers. Recall #F-408/409-4.
CODE All lots.
MANUFACTURER Diamond Island Seafood, Portland, Maine.
RECALLED BY Manufacturer, by telephone and fax February 9, 1994. Firm-
initiated recall complete.
DISTRIBUTION Massachusetts, Maine.
QUANTITY (a) 60 5-ounce containers, and 6 2-pound containers; (b) 36
5-ounce containers were distributed.
REASON Product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Sea Garden Crabmeat, fresh all lump, in 16 ounce plastic
tub. Recall #F-410-4.
CODE None.
MANUFACTURER Sea Garden Seafoods, Inc., Valona, Georgia.
RECALLED BY Manufacturer, by telephone December 23, 1993. Firm-
initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 90 pounds were picked; firm estimates none remains on the
market.
REASON Product is contaminated with Listeria monocytogenes.
_______________
PRODUCT (a) Nova Salmon Bits; (b) White Fish Salad, both are packed
in 8 ounce rigid plastic containers. Recall #F-411/412-4.
CODE Sell by date 0315.
MANUFACTURER Blue Ribbon Smoked Fish, Brooklyn, New York.
RECALLED BY Manufacturer, by letter March 9, 1994. Firm-initiated
recall complete.
DISTRIBUTION New York.
QUANTITY Approximately 100 pounds of both products were distributed;
firm estimates none remains on the market.
REASON Product is contaminated with Listeria monocytogenes.
_______________
PRODUCT French Vanilla Ice Cream, in 3 gallon bulk containers.
Recall #F-413-4.
CODE None.
MANUFACTURER Taylor Milk Company, Ambridge, Pennsylvania.
RECALLED BY Tri-Point Ice Cream Sales Company, Ambridge, Pennsylvania,
by letter March 24, 1994. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, West Virginia, Ohio.
QUANTITY Undetermined.
REASON Product contains eggs and eggs are not declared on the
label.
-2- RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Fleishmann's Cream Yeast (Saccharomyces cerevisiae), bulk,
used in manufacture of bread products. Recall #F-405-4.
CODE Lot or mash numbers 75009, 16148, 75043, 75041, 16141,
16143, 16151, 16161, 16158 were co-mingled and distributed
in six lots.
MANUFACTURER Burns Philip Food, Inc., Oakland, California.
RECALLED BY Manufacturer, by telephone April 1, 1994. Firm-initiated
recall complete.
DISTRIBUTION Arizona, California.
QUANTITY Approximately 26,020 gallons were distributed.
REASON Product is contaminated with glass.
_______________
PRODUCT Hospitality brand Crisp Rice Cereal, packaged in 35 ounce
bags. Recall #F-406-4.
CODE DEC0994S & T through DEC1994S &T.
MANUFACTURER Gilster-Mary Lee Corporation, Perryville, Missouri.
RECALLED BY Gilster-Mary Lee Corporation, Chester, Illinois, by
telephone on or about January 28, 1994. Firm-initiated
recall complete.
DISTRIBUTION Texas, Arizona.
QUANTITY 852 cases (8 bags per case) were distributed.
REASON Product is contaminated with glass.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT LaCroix brand Bottled Spring Water in 0.5 and 1.5 liter
bottles. Recall #F-404-4.
CODE 1773QC, 1793QC, 1823QC, 1983QC, 1993QC, 2073QC, 2083QC,
2093QC, 2213QC, 2363QC, 2373QC, 2523QC, 2633QC, 2653QC,
2683QC, 2803QC.
MANUFACTURER North American Water Group, Liberty, Illinois (bottler).
RECALLED BY Winterbrook Beverage Group, Bellevue, Washington, by fax and
by telephone February 9, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 9,268 1.5-liter cases and 5,419 0.5-liter cases were
distributed.
REASON Product is contaminated with mold.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT OTC antacid products: (a) Extra Strength Antacid/Antigas
Oral Liquid, in 12 fluid ounce plastic bottles; (b) Myla-
Care Antacid/Anti-gas Oral Liquid, in 12 fluid ounce
bottles; (c) Antacid Oral Suspension, Antacid Oral Liquid
suspension, in 12 fluid ounce plastic bottles. Private
labels and product names: Valumed, Mylagel (Moore Medical
-3- Corp.); Pic N' Save, Antacid/Anti-Gas Suspension (National
Merchandise Co.); Valumed, Mylagel (Moore Medical Corp.);
WGI, Genlanta (Bart Pharmacal, Inc.); Myla-Kare, (Qualitest
Products, Inc.) Pic N' Save, Antacid/Antigas Suspension
(National Merchandise Co.); Antacid Oral Suspension
(Qualitest Products, Inc.) WGI, Almagma (Bart Pharmacal,
Inc). Recall #D-285/287-4.
CODE (a) Lot #40021 EXP 1/96 (Altaire label only);
(b) Lot #30335 EXP 12/95 (Altaire label only);
Lot #30231 EXP 10/95 (Private labels only);
Lot #30321 EXP 12/95 (Altaire and private labels);
Lot #30336 EXP 12/95 (Altaire and private labels);
(c) Lot #30312 (Altaire label only);
Lot #30304 (private labels only).
MANUFACTURER Altaire Pharmaceuticals, Inc., Holbrook, New York.
RECALLED BY Manufacturer, by telephone April 11, 1994, and by letters of
April 11 and 15, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 37,233 units were distributed; firm estimated 2,870 bottles
of product remained on the market at time of recall.
REASON Bacterial contamination.
_______________
PRODUCT Medical Oxygen USP, delivered to patients for home use, in E
size cylinders. Recall #D-291-4.
CODE All lots.
MANUFACTURER Roadrunner Oxygen and Medical Supply, Inc., Tucson, Arizona.
RECALLED BY Manufacturer, by letter April 15, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Arizona.
QUANTITY Not available.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Ban-Tuss HC, (hydrocodone Bitartrate 10 mg, Phenylephrine
HCl 30 mg, Phenylpropanolamine Hydrochloride 20 mg,
Pyrilamine Maleate 20 mg, Pheniramine Maleate 20 mg), in
gallon bottles, used as an anti-tussive, under the H.N.
Norton Co/Luchem label. Recall #D-288-4.
CODE Lot #7384.
MANUFACTURER H.N. Norton Company, Shreveport, Louisiana.
RECALLED BY Manufacturer, by telephone and letter May 5, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 420 gallon bottles were distributed; firm estimated 133
gallons remained on the market at time of recall.
REASON Potency not assured through expiration date.
-4- _______________
PRODUCT Chemdal Expectorant, (Codeine Phosphate 10 mg,
Phenylpropanolamine Hydrochloride 12.5 mg, Guaifenesin 100
mg), in pint bottles, under the H.N. Norton/Chemdal and
Qualitest/Quendal labels. Recall #D-289-4.
CODE Lot #6169.
MANUFACTURER H.N. Norton Company, Shreveport, Louisiana.
RECALLED BY Manufacturer, by telephone and by letter April 25, 1994.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 4,220 bottles were distributed.
REASON Subpotency of codeine phosphate ingredient.
_______________
PRODUCT Urimar-T 100's Rx tablets, indicated for the relief of local
symptoms which accompany urinary tract infections caused by
diagnostic procedures. Recall #D-290-4.
CODE All product with lot #A10M, EXP 8/95.
MANUFACTURER Manufacturing Chemists, Inc., Indianapolis, Indiana.
RECALLED BY Marnel Pharmaceutical, Inc., Lafayette, Louisiana, by
written notice May 11, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,216 bottles of 100 tablets were distributed.
REASON Tablets may be cracked.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF; (d) Fresh Frozen Plasma; (e) Recovered Plasma.
Recall #B-243/247-4.
CODE Unit numbers: (a) 1132AR, 1138BR, 381546, 440739, 620927,
631700; (b) 381546, 440739, 620927, 631700; (c) 1138BR;
(d) 631700; (e) 1132AR, 381546, 440739, 620927.
MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, Colorado.
RECALLED BY Manufacturer, by letters in April and May 1993. Firm-
initiated recall complete.
DISTRIBUTION California, Colorado, Missouri, New York, Florida.
QUANTITY (a) 6 units; (b) 4 units; (c) 1 unit; (d) 1 unit;
(e) 4 units.
REASON Blood products, which tested non-reactive for hepatitis B
surface antigen (HBsAg), but were collected from donors who
reported a history of hepatitis, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-284/285-4.
CODE Unit #4432579.
MANUFACTURER Sarasota Community Blood Bank, Sarasota, Florida.
RECALLED BY Manufacturer, by telephone August 5, 1993, followed by
letter August 10, 1993. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component.
-5- REASON Blood products, which were collected from a donor who had
visited an area designated as endemic for malaria, were
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma.
Recall #B-286/288-4.
CODE Unit numbers: (a) 31F05493, 31L78068; (b) 31F05493;
(c) 31F05493.
MANUFACTURER The American National Red Cross, Buffalo, New York.
RECALLED BY Manufacturer, by letters of September 2 and 9, 1992, and
December 7, 1992. Firm-initiated recall complete.
DISTRIBUTION New York, South Carolina.
QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit.
REASON Blood products, collected from a donor who either reported
medication with methotrexate or reported a history of
cancer, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Red Blood Cells, Leukocytes
Removed; (c) Recovered Plasma. Recall #B-297/299-4.
CODE Unit numbers: (a) H25342, M64917, M64931; (b) M64935;
(c) M64917, M64931, M64935.
MANUFACTURER Tacoma Pierce County Blood Bank, Tacoma, Washington.
RECALLED BY Manufacturer, by telephone February 1 and 2, 1994, and April
14, 1994, followed by letters dated February 28, 1994, March
1, 1994, and April 14, 1994. Firm-initiated recall
complete.
DISTRIBUTION California, Washington state, Missouri.
QUANTITY (a) 3 units; (b) 1 unit; (c) 3 units.
REASON Blood products, that tested initially reactive for HBsAg,
were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Recovered Plasma. Recall #B-289-4.
CODE Unit #31L78068.
MANUFACTURER The American National Red Cross, Buffalo, New York.
RECALLED BY Manufacturer, by letter September 11, 1992. Firm-initiated
recall complete.
DISTRIBUTION Switzerland.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who reported a history
of cancer, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Red Blood Cells, Leukocytes
Removed; (c) Platelets; (d) Platelets, Pheresis; (e) Fresh
Frozen Plasma; (f) Recovered Plasma. Recall #B-300/305-4.
-6- CODE Unit numbers: (a) H25318, H25326, H25330, H25601, H25344,
H25353, H25354, L03926, L03932, L03934, L03940, L04330,
M64916, M64918, M64932, M64936; (b) M64929;
(c) H25318, L03926, L03932, L03934; (d) H25327, H25355;
(e) H25318, H25326, H25344, H25354, L03926, L03932, L03934;
(f) H25353, L04330, M64916, M64918, M64929, M64932, M64936,
M66543.
MANUFACTURER Tacoma Pierce County Blood Bank, Tacoma, Washington.
RECALLED BY Manufacturer, by telephone February 1 and 2, 1994, followed
by letters dated February 28, 1994, and March 1, 1994.
Firm-initiated recall complete.
DISTRIBUTION California, Washington state, Missouri.
QUANTITY (a) 16 units; (b) 1 unit; (c) 4 units; (d) 2 units;
(e) 7 units; (f) 8 units.
REASON Blood products, that either tested initially reactive for
HBsAg or negative for HBsAg, but were collected from donors
who previously tested initially reactive for HBsAg, were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Ames Brand Glucostix Reagent Strips:
(a) Glucostix bottles of 50, product code 2627;
(b) Glucostix bottles of 100, product code 2628;
(c) Glucostix bottles of 25, product code 2629;
(d) Gluco Meter II, II w/ memory, M, & QA kits w/
glucostix;
(e) Glucofilm bottles of 25, product code 2585;
(f) Glucofilm bottles of 50, product code 2582;
(g) Glucofilm bottles of 100, product code 2583;
(h) Glucometer 3, QA, & M+ 1 kit and kits w/
glucofilm. Recall #Z-689/696-4.
CODE All codes.
MANUFACTURER Miles, Inc., Diagnostics Division, Elkhart, Indiana.
RECALLED BY Miles, Inc., Diagnostic Div., Mishawaka, Indiana, by, letter
February 1, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Over 1 million.
REASON Lower than expected results can be obtained from areas of
high altitude, which may be due to the barometric pressure
and lower oxygen content at higher altitudes.
_______________
PRODUCT Pulmanex Pulmonary Manual Resuscitators, neonatal,
pediatric, infant and adult sizes, used to provide emergency
mechanical ventilation. Recall #Z-792-4.
CODE All units with lot numbers 348079 through 352058.
MANUFACTURER Bird Life Design (BLD), Dallas, Texas.
RECALLED BY Manufacturer, by telephone April 22 and 25, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
-7- QUANTITY 39,297 units were distributed.
REASON Packaging may not include a mask or elbow accessories
resulting in a inoperable critical device.
________________
PRODUCT Adult, Pediatric, and Infant Resuscitators:
(a) Adult Resuscitators Model numbers: K4000EA, K4001,
K4020, K4020EA, K4021, K4021EA;
(b) Pediatric Resuscitators Model numbers: K4130, K4130EA,
K4133, K4133, K4133EA, K4143EA;
(c) Infant Resuscitators Model numbers: K4230, K4230EA,
K4235, K4235EA, K4245, K4245EA. Recall #Z-794/796-4.
CODE (a) 34048, 34049, 34047, 34056, 34046, 34050
(b) 34053, 34028, 34030, 34051, 34032, 34057
(c) 34054, 34037, 34029, 34055, 34052, 34027.
MANUFACTURER Kirk Specialty Systems (KSS), Carrollton, Texas.
RECALLED BY Manufacturer, by telephone followed by letter March 28,
1994. Firm-initiated recall complete.
DISTRIBUTION Arkansas, Florida, Indiana, Missouri, New Jersey, New York,
Ohio, Oregon, Pennsylvania, Texas, Washington state.
QUANTITY 443 units were distributed; firm estimates none remains on
the market.
REASON The carbon dioxide color indicator strip may show an
insufficient or slower than expected color change in the
presence of carbon dioxide.
_______________
PRODUCT Dual Lumen Catheters, intended for use in vascular access,
primarily in hemodialysis. Recall #Z-841-4.
CODE Lot numbers: AT111, AT180, AT110, AS530, AT181, AT182,
AT186.
MANUFACTURER Neostar Medical Technologies, Inc., King of Prussia,
Pennsylvania.
RECALLED BY Manufacturer, by telephone April 5 or 6, 1994, followed by
letter dated April 15, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Austria, England, Pakistan, The Netherlands.
QUANTITY All but 10 units.
REASON There appeared to be compromised seals and some evidence of
seal creep on the product that had been processed using an
impulse sealer. Because of the potential for compromised
seals in the involved lots there is a lack of assurance of
sterility.
_______________
PRODUCT Medcomp Mini-Kit Trays, containing either duo-flow XTP
double lumen catheter and accessories or femoral vein
catheter and accessories, and are used for hemodialysis with
the double lumen catheter being used for temporary vascular
access in the hemodialysis, apheresis hemofiltraton or
plasmapheresis treatments and the femoral vein catheter
being used for use in attaining short term vascular access
for hemodialysis in the femoral veins:
-8- (a) Medcomp Mini-Kit Tray, Catalog No. XTP114MT.
(b) Medcomp Mini-Kit Tray, Catalog No. XTP116CT.
(c) Medcomp Mini-Kit Tray, Catalog No. XTP116MT,
(d) Medcomp Mini-Kit Tray, Catalog No. XTP116MT,
(e) Medcomp Mini-Kit Tray, Catalog No. XTP118MT,
(f) Medcomp Mini-Kit Tray, Catalog No. XTP118MT,
(g) Medcomp Mini-Kit Tray, Catalog No. MCFK100PA,
(h) Medcomp Mini-Kit Tray, Catalog No. MCFK64,
(i) Medcomp Mini-Kit Tray, Catalog No. SSL122OM,
(j) Medcomp Mini-Kit Tray, Catalog No. TRAY #128,
(k) Medcomp Mini-Kit Tray, Catalog No. TRAY #141,
(l) Medcomp Mini-Kit Tray, Catalog No. TRAY #254.
Recall #Z-842/853-4.
CODE Lot Numbers: (a) M418280; (b) M416050; (c) M416770,
M417440; (d) M417620, M416410, M418000, M418610;
(e) M416040, M417290, M418560, M418570, M419280;
(f) M417960, M418240, M418440; (g) M415930;
(h) M416280; (i) M413830; (j) M416530; (k) M416540, M418200,
M418960; (l) M415330.
MANUFACTURER Medical Components, Harleysville, Pennsylvania.
RECALLED BY Manufacturer, by telephone and by Fax April 15, 1994,
followed by letter April 18, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION New Jersey, Florida, Tennessee, Kansas, and international.
QUANTITY 615 units.
REASON 1mm to 5mm holes found in the trays due to a low sheet
temperature of the tray material and a difficult draw ratio.
_______________
PRODUCT Sterile Laparotomy Sponges:
(a) 4" X 8" Lap Sponges, Product No. 9-408E;
(b) 4" X 18" Lap Sponges, Product Nos.: 0-418,
1-418, 1-418-1, 5-418, 6-418, 8-418, 9-418,
9-418B-N, 9-418E, 21-418, 200-418, 1-418NH,
1-418PB, 5-419, 6-419, 5-419R, 0-418R, 1-418R,
5-418R, 200-418R, 31-554, 31-641, 1-418F;
(c) 8" X 36" Lap Sponges, Product Nos.: 0-836, 0-836-1,
1-836, 1-836-1, 5-836, 6-836, 9-836, 32-219, 200-836,
1-836NH, 1-836PB, 5-837, 6-837, 5-837R, 0-836R, 1-836R,
5-836R, 200-836R, 31-897;
(d) 12" X 12" Lap Sponges, Product Nos.: 0-1212, 1-1212,
5-1212, 6-1212, 8-1212, 9-1212, 9-1212E, 9-1212V, 200-1212,
1-1212NH, 5-1212NH, 5-1213NH, 5-1213, 6-1213, 5-1213R,
0-1212R, 1-1212R, 5-1212R, 9-1212R, 200-1212R;
(e) 18" X 18" Lap Sponges, Product Nos.: 0-1818,
1-1818, 1-1818-2, 1-1818-B, 5-1818, 6-1818,
8-1818, 9-1810-V, 9-1818, 9-1818B-N, 9-1818E,
9-1820-V, 21-1818, 25-1818, 200-1818,
1-1818NH, 5-1818NH, 200-1818NH, 5-1819NH,
5-1819, 8-1819, 26-1818PB, 0-1819R, 5-1819R,
6-1819R, 6-1818MR, 0-1818R, 1-1818R,
1-1818R-N, 5-1818R, 6-1818R, 200-1818R, 31-943;
-9- (f) 18" X 36" Lap Sponges, Product Nos.: 1-1836,
1-1836-3, 1-1836-5, 6-1836, 9-1836E, 32-099.
Recall #Z-855/860-4.
CODE All lots distributed since 01/01/91, and bearing lot numbers
greater than 12683 and less than 17013.
MANUFACTURER Qualtex, Inc., Rose Hill, Virginia.
RECALLED BY DeRoyal Industries, Inc., Powell, Tennessee, by letters sent
on or about April 8, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico.
QUANTITY Firm estimated that no more than 2,500 cases of all products
remained in commerce at the time of recall initiation.
REASON Devices may be non-sterile due to possible microbiological
contamination.
_______________
UPDATE Recall #Z-711/719-4, Cobe Spectra Apheresis System - Pump
Rotor, which appeared in the May 18, 1994, Enforcement
Report should read:
(a) Catalog #950000-000
(b) Catalog #950000-001
(c) Catalog #950000-002
(d) Catalog #950000-003
(e) Catalog #950000-004
(f) Catalog #950000-005
(g) Catalog #950000-006
(h) Catalog #950000-008. Recall #Z-711/718-4.
SEIZURES:
=================================================================
_______________
PRODUCT "Jogging in a Jug" and accompanying promotional literature
(94-650-492, et al).
CHARGES New drug - There is no approved application in effect for
such article. Misbranded - The article's labeling fails to
bear adequate directions for use, and it is not exempt from
such requirements since it is an unapproved new drug.
LOCATION Third Option Laboratories, Inc., Muscle Shoals, Alabama.
FILED May 18, 1994; U.S. District Court for the Northern
District of Alabama, Northern Division; Civil #CV-94-U-1209-
NW; FDC #66906.
SEIZED May 19, 1994 - goods valued at approximately $77,000.
_______________
PRODUCT Liquid Medical Oxygen and components (94-610-670).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture, processing,
packing, and holding do not conform to and are not operated
and administered in conformity with current good
manufacturing practice requirements.
-10- LOCATION Homedco, Peoria, Illinois.
FILED May 11, 1994; U.S. District Court for the Central District
of Illinois; Civil #94-1217; FDC #66953.
SEIZED May 13, 1994 - goods valued at approximately $75,000.
-11-
END OF ENFORCEMENT REPORT FOR JUNE 1, 1994. BLANK PAGES MAY FOLLOW.
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