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
08/07/1990
FDA Enforcement for the week of August 8, 1990
FDA ENFORCEMENT REPORT
FOR AUGUST 8, 1990
August 8, 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: Cold Smoked Salmon in vacuum packed flexible bags
which are unlabeled and uncoded. Recall #F-574-0.
Code: Uncoded.
Manufacturer: Josephson's Smokehouse, Astoria, Oregon.
Recalled by: Manufacturer, by telephone May 9, 1990. Firm-initiated
recall complete.
Distribution: Oregon, Utah.
Quantity: Firm estimates none remains on market.
Reason: Product is contaminated with Listeria monocytogenes.
----
-1-
Product: "Pride of Virginia" Potato Salad in 12 oz. plastic
containers. Recall #F-575-0.
Code: "4/16".
Manufacturer: Pride of Virginia Meats, Inc., Lynchburg, Virginia.
Recalled by: Manufacturer by visit April 12-13, 1990. Firm
initiated recall complete.
Distribution: Virginia.
Quantity: 125 gallons of potato salad was distributed.
Reason: Product contaminated with Listeria monocytogenes.
----
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.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: (a) Isopropyl Alcohol labeled as "Isopropyl Rubbing
Alcohol";
(b) Biofiran Tincture labeled as "Biofiran Tintura";
(c) Biofiran Solution labeled as "Biofiran";
(d) Ethyl Alcohol labeled as "Ethyl Rubbing Alcohol;
(e) Denatured Alcohol (Methanol) labeled as "Solvente
Industrial";
(f) Ammonium water labeled as "Agua de Amonia";
(g) Glycerine USP Solution labeled as "Glicerina U.S.P.";
(h) Povidone Iodine Solution labeled as "Metadine Scrub";
(i) Povidone Iodine Solution labeled as "Metadine
Solution";
(j) Hydrogen Peroxide Solution labeled as "Hydrogen
Peroxide" Recall #D-320/329-0.
Code: None used.
-2-
Manufacturer: Duqui, Inc., Barrio Palmas, Catano, Puerto Rico.
Recalled by: Manufacturer by telephone beginning July 3, 1990
followed by letter July 5, 1990. Firm initiated recall
ongoing.
Distribution: Puerto Rico, Virgin Islands.
Quantity: (a) 2,231/gallons, 1,218/1/2 gallon containers;
(b) 12/1 oz. bottles; (c) 474/gallons.; (d) 84/16 oz.
bottles; (e) 89/gallons.; (f) 12/8 oz. bottles;
(g) 24/1 oz. bottles; (h) 56/gallons.; (i) 48/gallons.;
(j) 4,056/16 oz. bottles were distributed.
Reason: Subpotency of the isopropyl alcohol product and current
good manufacturing practice deficiencies for all products.
----
Product: Pentaerythritol Tetranitrate Sustained Release Tablets
80 mg., an Rx drug used in the prophylactic treatment of
angina pectoris (pain associated with coronary artery
disease) in bottles of 100's and 1000's under the
following labels: Rugby, Goldline, Schein, Geneva Generic
Vita-Rx, Bioline, Dixon's, Shane Major, H.L. Moore,
Genetco, Recall #D-331-0.
Code: Lot #781128, Exp. date 2/92.
Manufacturer: Bolar Inc., Humacao, Puerto Rico.
Recalled by: Bolar Pharmaceutical Co., Inc., Copaigue, New York
by letter July 11, 1990. Firm initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,583/100 bottles; 312/1000 bottles were distributed;
firm estimates approximately 10% remains on the market.
Reason: Product failed dissolution specifications.
----
Class III -
Product: Kasdenol, contains "Clorpactin WCS-60" brand of
Monxychorosene, packaged in 10 cc glass bottles, an
OTC product used as a germicidal mouth was and gargle,
and for the relief of bleeding gums, cleansing the mouth;
deodorizing the mouth and for the improvement of oral and
dental hygiene, Recall #D-318-0.
Code: Lot #60-8902, Exp. date 12/90.
Manufacturer: United Guardian, Inc., Hauppauge, New York.
Recalled by: Manufacturer, by letter June 13, 1990. Firm initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 4,224 bottles were distributed.
Reason: Product below specification for available chlorine.
----
-3-
Product: Hydrocortisone Cream 0.5% in 1 ounce tubes, an OTC topical
steroid drug, Recall #D-319-0.
Code: Lot #5513, Exp. date 1/93.
Manufacturer: Pharmafair, Inc., Hauppauge, New York.
Recalled by: Manufacturer, by letter July 2, 1990. Firm initiated
recall ongoing.
Distribution: California, Pennsylvania.
Quantity: 8,532/1 ounce tubes were distributed.
Reason: Subpotency.
----
Product: Nasalcrom (cromolyn sodium nasal solution, USP, an
Rx drug used for the prevention and treatment of the
symptoms of allergic rhinitis, packaged in a 13 ml.
bottle attached to a pump and actuator, Recall #D-330-0.
Code: Lot #ALF48W, Exp. date 10/91.
Manufacturer: Fisons PLC, Pharmaceutical Division, Crewe Chechshire,
England.
Recalled by: Fisons Pharmaceuticals, Rochester, New York, by letter
July 3, 1990. Firm initiated recall ongoing.
Distribution: Nationwide.
Quantity: 32,058 units were distributed.
Reason: The Rynacrom portion of the lot was packaged with an incorrect
package insert.
----
Product: Imferon (iron dextran injection, USP packaged in 2 ml
ampules, 10 ampules per box, an Rx drug used for
intramuscular or intravenous use in patients with
documented iron deficiency in whom oral administration
is unsatisfactory or impossible, Recall #D-332-0.
Code: Lot #MW300A, Exp. date 1/95.
Manufacturer: Fisons PLC, Pharmaceutical Division, Crewe Chechshire,
England.
Recalled by: Fisons Pharmaceuticals, Rochester, New York by letter
July 3, 1990. Firm initiated recall ongoing.
Distribution: Nationwide, Puerto, Rico.
Quantity: 24,880 units were distributed.
Reason: Product does not meet USP requirements for particulate
matter.
----
-4-
Product: Hydrochlorothiazide 25 mg. tablets, USP in 100 and 1000
tablet bottles, an Rx drug used as a diuretic, under
the following labels: Major Pharmaceuticals; Goldline;
Recall #D-333-0.
Code: Lot #2083-175, Exp. date 4/92.
Manufacturer: Zenith Laboratories Inc., Northvale, New Jersey.
Recalled by: Manufacturer, by telephone May 30, 1990, with follow-up
letter June 20, 1990. Firm initiated recall ongoing.
Distribution: Florida, California, Illinois, Michigan.
Quantity: 432/100 bottles, 3,287/1000 bottes were distributed.
Reason: Incorrect identification number on tablets.
----
Product: Hexatussin Syrup; each 5 ml. contains Hydrocodone,
Bitartrate 2.5 mg., Phenylephrine HCl 5 mg., Pyrilamine
Maleate 6 mg., Chlorpheniramine Maleate 2 mg., Phenindamine
Tartrate 5 mg., Ammonium Chloride 50 mg., and Alcohol
5%, an Rx drug Schedule III oral liquid drug used for the
symptomatic relief of cough and nasal congestion, under
the following labels: PBI Hexatussin Syrup; Posituss Syrup,
Recall D-337-0.
Code: Lot #'s 17903A, 17903C, 17903E, 17903F, Exp. date 3/91.
Manufacturer: Pharmaceutical Basics, Inc., Morton Grove, Illinois.
Recalled by: Manufacturer, by letter Jul7 23, 1990. Firm initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 9,288 bottles were distributed.
Reason: The Phenindamine Tartrate ingredient is subpotent.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Sunbronze STSSW28TTS Sunlamp. Recall #Z-744-0.
Code: Serial #'s 351, 354 thru 356, 362, 368, 369, 380, 416.
Manufacturer: European Sun Systems, Inc., St. Louis, Missouri.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan July 12, 1990. Firm-initiated field
correction complete.
Distribution: Indiana.
Quantity: 9 units were distributed; firm estimates all units
were corrected.
Reason: Noncompliance with performance standard for sunlamp
products.
----
-5-
Class III-
Product: One Time Sterile Medical Trays as follows: (a) Dressing
Change Tray, Product No. S7881; (b) CVC Dressing Tray
Product No. S7842; (c) Sterile Custom TPN Tray,
Product No. S7858; (d) Sterile Custom TPN Tray,
Product No. S7879; (e) Sterile TPN/CVP Dressing Change
Tray, Product No. 61248; (f) Sterile TPN/CVP Subclavian
Dressing Tray (W/Tegaderm) Product No. 61249, Recall
#Z-753/758-0.
Code: Lot #'s: (a) 190165, Exp. date 01/93; (b) 190105 thru 190107
Exp. date 10/92; (c) 190111, Exp. date 10/92; (d) 190127,
Exp. date 10/92; (e) 190050, Exp. date 11/92; (f) 189404,
Exp. date 10/92.
Manufacturer: Acme United Corporation, Goldsboro, North Carolina.
Recalled by: Manufacturer by letter June 21, 1990. Firm initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 987 trays (20 trays per case) were distributed.
Reason: Product may contain a crack in the blister package which may
compromise sterility.
----
Product: Ohmeda 4700 OxiCap Monitor, is a microprocessor control
device designed to (1) monitor arterial oxygen saturation
(Sa02) for detection of hypoxemia; (2) monitor end-tidal
carbon dioxide (etCO2) for detection of changes in the
adequacy of ventilation; (3) monitor the percent of
delivered inspired oxygen to ensure that the patient is
receiving the prescribed amount, Recall #Z-759-0.
Code: All serial numbers.
Manufacturer: Ohmeda, Louisville, Colorado.
Recalled by: Manufacturer by letter April 27, 1990. Firm initiated
recall ongoing.
Distribution: Nationwide, international.
Quantity: Approximately 2,500 units were distributed.
Reason: The device may "lock-up" and display test pattern values
for oximeter parameters when initially turned on.
----
Product: (a) Bard Woven Phillips Follower Urethral Catheter, 12 fr.;
(b) Bard Woven Phillips Follower Urethral Bougie 12 fr.;
(c) Urethral Catheter GIFT (Gamete Intra Fallopian
Transfer) Set 19 fr., Recall #Z-761/763-0.
Code: (a) Catalog No. 021512, Lot #03AA2078; (b) Catalog No. 024012
Lot #03AA2082; (c) Catalog No. 021519, Lot #03AA3005.
Manufacturer: Bard Urological Division, Covington, Georgia.
Recalled by: Manufacturer by letter and telephone May 17, 1990.
Firm initiated recall ongoing.
-6-
Distribution: Nationwide, Canada.
Quantity: 130 units were distributed.
Reason: The catalog numbers of the urethral catheters (product nos.
021512 and 021519) may be switched with the catalog number of
the urethral bougie (product no. 024012). The devices look
very similar except the catheter has a hollow lumen and the
follower bougie is solid.
----
Product: Diascam brand glucose test strips individually wrapped in
boxes of 25's, Recall #Z-766-0.
Code: Lot #633333A, Exp. date 4/90.
Manufacturer: Behringwerke AG, Federal Republic of Germany (strips).
Recalled by: Home Diagnostics, Inc., Eatontown, New Jersey by letter
October 26, 1989. Firm initiated recall complete.
Distribution: Nationwide, West Germany, United Kingdom, Italy, Israel,
Turkey.
Quantity: 3,315 boxes were distributed (25 per box).
Reason: The device may contain strips which are discolored and could
result in falsely low glucose readings.
----
Product: Sharplan C02 Surgical Laser System Model Nos. 1050 and 1075.
Recall #Z-767/768-0.
Code: All lots.
Manufacturer: Laser Industries, Ltd., Tel Aviv, Israel.
Recalled by: Sharplan Lasers Inc., Allendale, New Jersey by letter
April 18, 1990. Firm initiated recall ongoing.
Distribution: Nationwide.
Quantity: 45 units were distributed.
Reason: Potentential for low-power instability of the device in the
super pulse mode at a setting below 5 watts.
----
Product: Rapimat Urine Control, Level 1, Kit, Recall #Z-765-0.
Code: Lot #13880.
Manufacturer: I.C.L. (also known as Hycor Biomedical Inc.), Garden Grove
California.
Recalled by: Behring Diagnostics Inc., Somerville, New Jersey by
telephone June 21, 1989 follow-up letter dated July 19,
1989. Firm initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 305 units were distributed.
Reason: Some kits contained the package insert for Rapimat Urine
Control Level II (abnormal) instead of the package insert
for Level I (normal) controls.
----
-7-
VETERINARY PRODUCTS
CLASS I-
NONE
CLASS II-
NONE
----
CLASS III-
Product: Tylan (Tylosin) Plus Vitamins, oral antibiotic solution
packaged in 250 gram bottles for use in swine for the
control and treatment of swine dysentery (bloody scours)
caused by pathogens sensitive to tylosin, Recall #V-052-0.
Code: Lot #'s 3DZ17B, Exp. date 1/1/91; 2PN38A, Exp. date 12/1/90;
3AX10B, Exp. date 9/1/90; 3AJ75A Exp. date 8/1/90;
2NZ32A Exp. date 8/1/90; 2NL19A Exp. date 7/1/90.
Manufacturer: Elanco Products Company (division of Eli Lilly & Co.),
Indianapolis, Indiana.
Recalled by: Manufacturer by letter June 14, 1990. Firm initiated recall
ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: 56,591 bottles were distributed.
Reason: Subpotency or super-potency of tylosin ingredient.
----