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
09/16/1992
RECALLS AND FIELD CORRECTIONS: September 16, 1992
FOODS -- CLASS I
92-38
PRODUCT Pewter Baby Cups 2-1/2" high with hand, boy & girl cups.
Recall #F-522/523-2.
CODE Not coded.
MANUFACTURER Shirley Pewter Company, Williamsburg, Virginia.
RECALLED BY Manufacturer, by Fax June 15, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Virginia and South Carolina, retail stores, tourist sales and
catalog sales may be nationwide.
QUANTITY Approximately 650 cups.
REASON Products contain leachable lead.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
PRODUCT Clozaril (Clozapine) 100 mg SandoPak (unit dose pack), 100
tablets, a Rx anti-psychotic drug. Recall #D-497-2.
CODE All lots on the market as of 7/31/92.
MANUFACTURER Sandoz Pharmaceuticals Corporation, East Hanover, New Jersey.
RECALLED BY Manufacturer, by letters dated July 24 and 31, 1992.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates 1,000 SandoPaks remain on the market.
REASON Some blister cavities of the unit dose strips contained two
tablets instead of one.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Various Rx and OTC drug products requiring refrigerated storage
conditions:
(a) Repository Corticotropin Injection, USP, ACTH, in 5 ml
vials:
(i) 40 units/ml, Major item #179606;
(ii) 80 units/ml, Major item #184143;
(b) Major Naphazole A Ophthalmic Solution, Naphazoline
Hydrochloride 0.025% and Pheniramine Maleate 0.3%
Ophthalmic Solution, USP (Sterile), in 15 ml dropper container,
Major item #135418;
(c) Major Sulfacetamide Sodium Ophthalmic Solution, USP, 10%
(Sterile), in 15 ml bottle, Major item #129155;
(d) Acetaminophen Suppositories:
(i) Mapap Pediatric Rectal Suppositories, Acetaminophen 120 mg,
12 suppositories per box, Major item #127449, M-11 on box;
(ii) G & W Acephen Acetaminophen Rectal Suppositories,
Acetaminophen 325 mg, 12 suppositories per box, Major item
#184200;
(iii) Mapap Rectal Suppositories, Acetaminophen 650 mg, 12
suppositories per box, Major item #127464, M-11 on box;
(e) G & W Truphylline Aminophylline Suppositories, 500 mg, 10
suppositories per box, Major item #184150;
(f) Major Phenameth Promethazine HCl Suppositories, 50 mg, 12
and 25 suppositories per box, Major item #153866;
(g) Major Erythromycin Ethylsuccinate Oral Suspension, in 1
pint bottles:
(i) 200 mg/5 ml: Major item #140293;
(ii) 400 mg/5 ml: Major item #140301;
(h) Major Erythromycin Estolate Oral Suspension, USP, in 1 pint
bottles, store in refrigerator to preserve taste:
(i) 125 mg/5 ml: Major item #140319;
(ii) 250 mg/5 ml: Major item #140335. Recall #D-482/494-2.
CODE Ellis Division Ormond Beach, FL, Woburn, MA and Winston Salem,
NC locations: All products, all lots within expiration date;
Murray Division, Murray, KY and Houston, TX locations: items
a, b, c, g, h; all lots within expiration date;
Crown Division Chicago, IL and Omaha, NE locations: items b,
e, f (12's): All lots;
item c, lot #0693 and 0398 only;
item g - ii, lot #0020 only;
item a - i, all lots, Omaha customers only;
Michigan Division, Auburn Hills, MI location:
item b, lot 0874 only;
item d - ii, all lots;
item h - ii, lot #13097 only;
Ultra Division, Seattle, WA and San Diego, CA locations:
items b, f: all lots;
item c, all lots for Seattle and lot 9764 only for San Diego.
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MANUFACTURER (a) Organics/LaGrange, Chicago, Illinois;
(b, c, g) Pharmafair, Inc., Tampa, Florida;
(b, c) Bausch & Lomb Pharmaceuticals, Clearwater, Florida;
(d, e, f) G & W Laboratories, Inc., South Plainfield, New
Jersey;
(g, h) Barre-National, Inc., Baltimore, Maryland.
RECALLED BY Major Pharmaceuticals, Chicago, Illinois (responsible firm), by
letter August 25, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 189 vials of 40 u/ml and 417 vials of 80 u/ml repository
corticotropin; 10,540 bottles of Naphazole A; 48,011 bottles of
Sulfacetamide; 1,108 125-mg, 420 325-mg, & 1,119 650-mg boxes
of acetaminophen suppositories; 214 boxes of aminophylline
suppositories; 801 x 12 and 121 x 25 boxes of promethazine
hydrochloride suppositories; 713 200-mg and 562 400-mg
bottles of erythromycin ethylsuccinate; and 168 125-mg
and 495 250-mg bottles of erythromycin estolate were
distributed which had not been refrigerated. The firm
estimates that 10% of the product remains on the market.
REASON The products were not held at the labeled storage temperatures,
which could affect the products' potency and/or physical
properties.
PRODUCT Rx small volume parenterals in prefilled syringes:
(a) Heparin Lock Flush Solution, USP, 100 units/ml, in 3 ml
syringes, catalog #10773 and 5 ml syringes, catalog #10775,
with the 3 ml syringe also packaged in the Lok-Pak-N Heparin
Lock Flush Procedure Pack, catalog #11873;
(b) Sodium Chloride Injection, USP, 0.9%, Preservative Free, in
2 ml syringe, catalog #11272, packaged in the Lok-Pak-N Heparin
Lock Flush Procedure pack, catalog #11771. Recall #D-495/496-2.
CODE Lot numbers: (a) 91M003B (5 ml), 91M004D (3 ml), 91M004C (Kit
#11873); (b) 91M002 (2 ml), 91M001B (kit #11771.
MANUFACTURER Smith & Nephew SoloPak, Franklin Park, Illinois.
RECALLED BY Smith & Nephew SoloPak, Elk Grove Village, Illinois, by letters
dated August 18, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 55,560 3-ml syringes, 115,200 3-ml syringes in kits, and
92,280 5-ml syringes; (b) 163,320 2-ml syringes in kits were
distributed; firm estimates that 10 percent of the product
remains on the market.
REASON Lack of assurance of sterility.
PRODUCT Ritalin (Methylphenidate Hydrochloride), 20 mg, 100 tablets, an
Rx product for oral administration as a central nervous system
stimulant. Recall #D-498-2.
CODE Lot numbers: 1B005856 EXP 11/96, 2B005856 EXP 11/96, 1B006379
EXP 12/96.
MANUFACTURER Ciba-Geigy Corporation, Pharmaceutical Division, Summit, New
Jersey.
-3-
RECALLED BY Manufacturer, by letter July 14, 1992, followed by telephone.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 28,476 units of lot 1B005856, 6,814 units of lot 2B005856, and
33,354 units of lot 1B006379 were distributed; firm estimates
20,500 units remain on the market.
REASON An incorrect National Stock Number (NSN) intended for
Ritalin-SR 20 mg was an error printed on the Ritalin 20 mg
label.
PRODUCT Various Lyphomed Rx injectable drug products:
(a) Aminophylline Injection, USP, 25 mg/ml, in 20 ml vials;
(b) Atropine Sulfate Injection, USP, 0.5 mg/ml, in 1 ml vials;
(c) Cyanocobalamin Injection, USP, 1,000 mcg/ml, in 1 ml vials;
(d) Diazepam Injection, USP, 5 mg/ml, in 2 ml vials;
(e) Heparin Lock Flush Solution, 10 USP units/ml, in 1 ml vials;
(f) Heparin Sodium Injection, USP, 10,000 USP units/ml, in 1 ml
vials;
(g) Lidocaine Hydrochloride Injection, USP, 2%, 20 mg/ml, in 2
ml vials;
(h) Mannitol Injection, USP, 25%, 250 mg/ml, in 50 ml vials;
(i) Multilyte-20 Multi-Electrolyte Concentrate, in 25 ml vials;
(j) Phenytoin Sodium Injection, USP, 50 mg/ml, in 2 ml and 5 ml
vials;
(k) Potassium Chloride for Injection Concentrate, USP,
Preservative Free, 2 mEq/ml, in 10 ml vials, and in 20 ml vials;
(l) Potassium Chloride for Injection Concentrate, USP, 2
mEq/ml, preserved, in 20 ml vials;
(m) Pyridoxine Hydrochloride Injection, USP, 100 mg/ml, in 1 ml
vials;
(n) Sodium Chloride Injection, USP, 23.4%, in 30 ml vials;
(o) Sterile Water for Injection, USP, in 5 ml vials, 50 ml
vials, and 100 ml vials;
(p) Thiamine Hydrochloride Injection, USP, 100 mg/ml, in 2 ml
vials. Recall #D-503/518-2.
CODE Lot numbers: (a) 320114, 320290, 320291; (b) 311244;
(c) 311250, 320371; (d) 320324; (e) 311199, 311210, 311307,
320024, 320120, 320186, 320158, 320168, 320208, 320214, 320354,
(f) 311213, 311299, 311302, 320105, 320111, 320195, 320451;
(g) 311238; (h) 310131, 310133, 310132, 310968, 320012, 320011;
(i) 320344; (j) 311288, 320044, 320129; (k) 311277, 320078,
311248, 320072, 320312; (l) 311340; (m) 311245, 320155; (n)
320403, 320185; (o) 311366, 320172, 311258, 320322;
(p) 320159, 320331.
MANUFACTURER Lyphomed, Division of Fujisawa USA, Inc., Grand Island, New
York.
RECALLED BY Lyphomed, Division of Fujisawa USA, Inc., Melrose Park,
Illinois, by letter August 28, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, The Bahamas, Nicaragua, Hong Kong, Peru, Malta.
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QUANTITY Vials distributed Estimated to remain on market
(a) 87,100 43,450
(b) 56,250 11,250
(c) 233,150 47,295
(d) 88,790 48,660
(e) 1,927,625 269,868
(f) 1,448,150 260,667
(g) 42,350 4,930
(h) 124,775 36,491
(i) 8,750 4,275
(j) 108,182 59,540
(k) 292,800 38,521
(l) 53,150 6,798
(m) 77,325 31,199
(n) 86,475 24,213
(o) 116,325 29,994
(p) 119,975 48,306
REASON The vials have a low fill volume.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Ben-Aqua Gel 5% (Benzoyl Peroxide 5%), in 4 ounce tubes.
Recall #D-499-2.
CODE Lot #H282 EXP 12/93.
MANUFACTURER Syosset Laboratories Company, Inc., Syosset, New York.
RECALLED BY Manufacturer, by letter August 6, 1992, followed by telephone
August 7, 1992. Firm-initiated recall ongoing.
DISTRIBUTION California, New Mexico, Minnesota, New York, New Jersey.
QUANTITY 918 units were distributed.
REASON Some tubes have leakage at the crimp.
PRODUCT Triamcinolone Acetonide Cream, 0.1%, 80 gram size.
Recall #D-500-2.
CODE Lot #H208 EXP 10/93.
MANUFACTURER Syosset Laboratories Company, Inc., Syosset, New York.
RECALLED BY Manufacturer, by letter August 13, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Florida, Illinois.
QUANTITY 1,208 tubes were distributed.
REASON Some tubes have leakage at the crimp.
PRODUCT (a) Thorazine (Chlorpromazine Hydrochloride) Concentrate 30
mg/ml, in 4 fluid ounce bottles; (b) Thorazine Syrup, 10 mg/5
ml in 4 fluid ounce bottles. Recall #D-501/502-2.
CODE Lot numbers: (a) X1-1T47 EXP 6/30/95;
(b) X3-OT72 EXP 11/30/93, X4-OT72 EXP 11/30/93, X5-OT72 EXP
11/30/92, X6-1T72 EXP 9/30/94, X7-1T72 EXP 9/30/94, X8-1T72 EXP
9/30/94, 2-2T72 EXP 2/28/95, 3-2T72 EXP 3/31/95.
MANUFACTURER Smithkline Beecham Pharmaceuticals Company, Cidra, Puerto Rico.
RECALLED BY Manufacturer, by letter mailed August 11, 1992. Firm-initiated
recall ongoing.
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DISTRIBUTION Nationwide.
QUANTITY (a) 4,120 bottles were distributed; firm estimates none remains
on the market; (b) 35,905 bottles were distributed; firm
estimates 4,000 bottles remain on the market.
REASON (a) Product does not meet pH specifications; (b) Potency not
assured if continuously stored at upper temperature limit.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Patient Circuit Body used with Neonatal High Frequency
Oscillatory Ventilators:
(a) Model 3100, part #766898; (b) Model 3100A, part #766895.
Recall #Z-1254/1255-2.
CODE Lot numbers: (a) 56920091; (b) 55728191.
MANUFACTURER Surgical Technologies, Inc., Brea, California.
RECALLED BY Sensormedics Corporation, Yorba Linda, California, by
interoffice memorandum dated January 10, 1992. Firm-initiated
recall complete.
DISTRIBUTION Colorado, Ohio, Michigan, California, South Carolina,
Pennsylvania, Maryland, Massachusetts, New York, Florida, Utah,
Washington state, Texas, Georgia, Tennessee, Iowa, Virginia,
Idaho.
QUANTITY Approximately (a) 80 2-unit boxes; (b) 60 4-unit boxes were
distributed.
REASON The patient circuit may separate at either end of the rigid
inspired tube or at the patient "wye", due to insufficient glue
and ultra-violet curing.
PRODUCT Above Knee Prosthetic Wood Block, "TWB-4", used as a component
of an artificial leg. Recall #Z-1259-2.
CODE Not coded.
MANUFACTURER Teh Lin, Taiwan.
RECALLED BY Daw Industries, Inc., San Diego, California, by telephone
December 31, 1991, and by letter January 23, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 166 units were distributed.
REASON The TWB-4 component was showing movement which could lead to
failure of the finished device.
PRODUCT Barrier Ultra Protection and Extra Protection Surgical Gowns
1. Reorder Nos. 0579 and 7-0579;
2. Reorder Nos. 20-9579 and 27-9579;
3. Reorder Nos. 0575 and 7-0575;
4. Reorder Nos. 0576 and 7-0576;
5. Reorder Nos. 0580 and 7-0580;
6. Reorder Nos. 20-9675 and 27-9675;
7. Reorder Nos. 20-9676 and 27-9676;
8. Reorder Nos. 20-9680 and 27-9680;
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9. Reorder Nos. 0230 and 7-0230;
10. Reorder Nos. 0244 and 7-0244;
11. Reorder Nos. 0263 and 7-0263;
12. Reorder Nos. 0284 and 7-0284;
13. Reorder Nos. 1041 and 7-1041;
14. Reorder Nos. 1062 and 7-1062;
15. Reorder Nos. 1156 and 7-1156;
16. Reorder Nos. 1223 and 7-1223;
17. Reorder Nos. 1237 and 7-1237;
18. Reorder Nos. 1238 and 7-1238;
19. Reorder Nos. 1239 and 7-1239;
20. Reorder Nos. 1263 and 7-1263;
21. Reorder Nos. 1267 and 7-1267;
22. Reorder Nos. 1269 and 7-1269;
23. Reorder Nos. 1273 and 7-1273;
24. Reorder Nos. 1291 and 7-1291;
25. Reorder No. 1051. Recall #Z-1263/1287-2.
CODE Lot Numbers with first four digits of 1811 through 3651 and
0012 through 1182;
MANUFACTURER Johnson & Johnson Medical, Inc., El Paso, Texas.
RECALLED BY Johnson & Johnson Medical, Inc., Arlington, Texas, by letter
July 20, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 218,168 cases (2,957,531 gowns) were distributed; firm
estimates 10,100 cases remain on the market.
REASON The gown liner can tear during donning and use, compromising
its integrity and function as an impervious barrier, resulting
in strike through.
PRODUCT Hulka Uterine Mobilizer, used for mobilizing the uterus.
Recall #Z-1288-2.
CODE Product #433-245, lot #31-609.
MANUFACTURER G.F. Instrumente, Heidelberg, Germany.
RECALLED BY Zinnanti Surgical Instruments, Chatsworth, California, by
letter April 9, 1990. Firm-initiated recall complete.
DISTRIBUTION Texas, Arizona.
QUANTITY 7 units were distributed; firm estimates none remains on the
market.
REASON The uterine sound part at the tip of the tenaculem may break
off and be retained inside the patient.
PRODUCT Inferno Moist Heat Therapy Unit, eight hot pack capacity, Model
917, a water bath used to heat up and maintain the hot packs at
a desired temperature. Recall #Z-1289-2.
CODE Serial numbers range from 183133 to 183137.
MANUFACTURER Polar Ware Company, Shoboygen, Wisconsin.
RECALLED BY Ferno Washington, Wilmington, Ohio, by telephone January 29,
1992. Firm-initiated recall complete.
DISTRIBUTION Oregon, Florida, Texas, Tennessee, Canada.
QUANTITY 5 units were distributed; firm estimates none remains on the
market.
-7-
REASON The capillary tube of the primary thermostat can come into
contact with a terminal on the safety thermostat, causing a
short circuit.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Calibration Gas 2 Cylinder used to calibrate a cutaneous gas
system (CGS) sensor. Recall #Z-1256-2.
CODE Part #550902, lot #WK12L79.
MANUFACTURER Puritan Bennett, City of Industry, California.
RECALLED BY SensorMedics Corporation, Yorba Linda, California, by letter
January 16, 1992. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, California, Maryland, Ohio, South Carolina,
Hawaii, Utah, Georgia, North Carolina, Colorado, Tennessee,
Kansas, Washington state, Florida.
QUANTITY 130 units were distributed.
REASON The calibration gas may have been blended incorrectly. The
incorrect mixture will cause a "Cal Gases May be Reversed"
message to be displayed on the station when trying to calibrate
a Cutaneous Gas System (CGS) Sensor.
PRODUCT Tandem-R Pap Kit, an immunoradiometric assay indicated for the
quantitative measurement of prostatic acid phosphatase (PAP) in
serum. Recall #Z-1260-2.
CODE Catalog #3073, Kit lot numbers: 290789 EXP 6/22/92, 290936 EXP
7/13/92, 290998 EXP 7/28/92, 291009 EXP 7/28/92, 291110 EXP
8/11/92. Zero diluent component lot #260333 EXP 3/20/93.
MANUFACTURER Hybritech, Inc., San Diego, California.
RECALLED BY Manufacturer, by letters of July 29, 1992 and August 5, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,139 kits were distributed.
REASON The firm neglected to put enough preservative in the calibrator
which has led to fungus growth in the vials.
PRODUCT Hemaflex Absorbable Collagen Hemostat rectangular textured pad,
2.5 cm x 5 cm (small), indicated for use in surgical procedures
(other than neurological, urological and ophthalmological
surgery) as an adjunct to hemostasis when control of bleeding
by ligature or other conventional methods is ineffective or
impractical. Recall #Z-1261-2.
CODE Catalog #2201-10, lot #19111C EXP 12/94.
MANUFACTURER Bioplex Medical B.V., a subsidiary of Bioplex Corporation,
Vaals, Holland.
RECALLED BY Bioplex Corporation, a subsidiary of Datascope Corporation,
Montvale, New Jersey, by letter March 31, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 693 pieces were distributed.
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REASON The outer pouch may not contain the lot numbers or expiration
date.
MEDICAL DEVICE SAFETY ALERTS
PRODUCT Aluminum Pump used on an Acidified Bicarbonate Dialysis
System. Safety Alert #M-092-2.
CODE All codes.
MANUFACTURER Community Dialysis Centers, Laguna Hills, California.
ALERTED BY Manufacturer, by letter July 31, 1992.
DISTRIBUTION Community Dialysis Centers.
QUANTITY Unknown.
REASON Patients may have been exposed to bicarbonate dialysate which
came into contact with a pump containing aluminum components.
This may result in elevated aluminum in patients' blood.
PRODUCT Medex C-Fusor Pressure Infusors, inflatable polyurethane cuffs
which are placed around solution bags to produce counter
pressure on arterial monitoring or central pressure lines. The
device may also be used to rapidly infuse blood products or IV
solutions:
(a) Catalog #MX4805; (b) Catalog #MX4806; (c) Catalog #MX4810;
(d) Catalog #MX4811; (e) Catalog #5104366; (f) Catalog
#5000359. Safety Alert #M-093/098-2.
CODE All lots.
MANUFACTURER Medex, Inc., Hilliard, Ohio.
ALERTED BY Manufacturer, by letter February 10, 1992.
DISTRIBUTION Nationwide and international.
QUANTITY 19,300 units were distributed.
REASON It came to the firm's attention that some customers used the
devices by removing the inflation bulb which is sold with the
device and by connecting the pressure infusor to a compressed
air line at the facility. The firm advised users they should
discontinue use of this method because the infusor may balloon
to the point of failure resulting in complete rupture of the
infusor's bladder.
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END OF ENFORCEMENT REPORT FOR SEPTEMBER 16, 1992. BLANK PAGES MAY
FOLLOW.
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