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
03/16/1994

Recalls and Field Corrections: Foods -- Class II -- 03/16/1994

MARCH 16, 1994 94-11

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Peak brand Garden Fresh Kale, packaged in 10 ounce bags.
Recall #F-303-4.
CODE All lots distributed prior to 11/20/93.
MANUFACTURER The Horton Fruit Company Louisville, Kentucky.
RECALLED BY Manufacturer, by telephone November 24, 1993. Firm-
initiated recall complete.
DISTRIBUTION Kentucky, Virginia.
QUANTITY Approximately 7,800 cartons (12 packages per carton) were
distributed; firm estimates none remains on the market.
REASON Product contained permethrin for which there is no
acceptable tolerance level.

_______________
PRODUCT Reese's Milk Chocolate Peanut Butter Cups, 1.6 ounces,
packed in intermediate boxes of 36 and shipped in one of two
size shippers (12 x 36 or 6 x 36). Recall #F-310-4.
CODE Lot 70KLV.
MANUFACTURER Hershey Chocolate USA, Stuarts Draft, Virginia.
RECALLED BY Hershey Chocolate USA, Hershey, Pennsylvania, by fax
February 1, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 613 cases of regular shippers (12 x 36) and 808 cases of
vendor shippers (6 x 36) were distributed.
REASON Plastic pieces found in product.

_______________
PRODUCT Fruit Jelly Candy assorted flavors packaged in cellophane
bags, 145 g net weight. Recall #F-311-4.
CODE Consume before Feb 02 1994.
MANUFACTURER China Shenzhen Agar-Agar Industry Company, Shenzhen, China.
RECALLED BY Hing Wah Food Products Ltd., Jersey City, New Jersey, by
visit. Firm-initiated recall was completed on June 7, 1993.
DISTRIBUTION New York.
QUANTITY 76 cases (36 packages per case) were distributed; firm
estimates none remains on the market.
REASON Product contained undeclared FD&C Yellow No. 5.

_______________
PRODUCT Chocolate Candy Pop with multicolored non-pareil sprinkles
on a stick in cellophane wrap, 1 ounce size.
Recall #F-315-4.
CODE None.
MANUFACTURER Gertrude Hawk Candy Shops, Inc., Dunmore, Pennsylvania.
RECALLED BY Manufacturer, by verbal instructions on January 14, 1994.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, New York.
QUANTITY 12 boxes, each containing 24 units were distributed. All
involved product has been returned and correctly labeled.
REASON Product contained undeclared FD&C Yellow No. 5.

_______________
PRODUCT Haddon House brand Crystallized Young Ginger Slices, 3
ounces. Recall #F-316-4.
CODE None.
MANUFACTURER Unknown. Product of Taiwan.
RECALLED BY Haddon House Food Products, Inc., Medford, New Jersey, by
letter dated November 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 368 cases (24 packages per case) were distributed.
REASON Product contains undeclared sulfites.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Canned Chunk Light Tuna in water, in 6-1/2 ounce cans.
Recall #F-312-4.
CODE TATCW/BFPC.
MANUFACTURER Thai Agrifods, Thailand.
RECALLED BY Cadierno Corporation, Guaynabo, Puerto Rico, by letter
September 23, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Puerto Rico, Virgin Islands.
QUANTITY Approximately 103 cases (12 cans per case) were distributed.

-2-REASON Samples analyzed by FDA show product does not meet the
requirements for standard fill weight for canned tuna.

_______________
PRODUCT Nutri System Artificially Flavored Apple Spice Muffins, 2
ounce packages containing 3 muffins. Recall #F-313-4.
CODE MAR2894, MAR2994, MAR3094, APR1494, APR2994.
MANUFACTURER Pewter Pot Muffin Company, Inc., Waltham, Massachusetts.
RECALLED BY Nutri System, Horsham, Pennsylvania, by telephone November
30, 1993, and by letters dated December 10, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide (recall codes mainly in North Carolina).
QUANTITY Firm estimates little, if any, product remains on the
market.
REASON Product is contaminated with mold.

_______________
PRODUCT Pathmark Fat Free Ranch Non-fat Dressing in 8 ounce bottles.
Recall #F-314-4.
CODE JAN 31 94, FEB 13 94, MAR 12 94, MAY 06 94, MAY 19 94, JUN
15 94.
MANUFACTURER Martin Gillet & Company, Inc., Baltimore Maryland.
RECALLED BY Manufacturer, by letter August 24, 1993. Firm-initiated
recall complete.
DISTRIBUTION New Jersey, New York, Connecticut, Pennsylvania, Delaware.
QUANTITY 331 cases were distributed.
REASON Product is contaminated with yeast.

_______________
PRODUCT Whole Dried Fennel Seeds, in 14 ounce plastic bottles, 7/8
ounce plastic cans, and 4 pound plastic bottles.
Recall #F-317-4.
CODE Lot numbers: 3L17 (14 oz), 3H17 (7/8 oz), 3H31 (4 lb).
MANUFACTURER C.F. Sauer Company, Inc., Richmond, Virginia.
RECALLED BY Manufacturer, by visit January 21, 1994. Firm-initiated
recall complete.
DISTRIBUTION Southeastern United States including Virginia, North
Carolina, South Carolina.
QUANTITY 13 cases (72 7/8-ounce units per case), 195 cases (6 14-
ounce units per case), 4 cases (4 4-pound units per case)
were distributed.
REASON Product is contaminated with insects.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT All lots of all OTC and Rx drug products repacked by Omega
Laboratories. The labels for each of the repacked drugs
will bear a statement reading, "Packaged by Omega
Laboratories, Mobile, AL". Recall #D-185-4.
CODE All lots.
MANUFACTURER Multiple manufacturers and distributors.

-3-RECALLED BY Unisource, Inc., doing business as Omega Laboratories, Inc.,
Mobile, Alabama, by telephone February 17, 1994, followed by
letter February 18, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto, Bermuda, England, Hong Kong.
QUANTITY Undetermined.
REASON Current good manufacturing practice deficiencies and
labeling deficiencies.

_______________
PRODUCT Forest Levothroid Tablets (levothyroxine sodium tablets,
USP), (a) 88 mcg (b) 112 mcg strengths, packaged in 21, 31,
and 100 tablet bottles, Rx for the replacement or
substitution therapy for diminished or absent thyroid
function. Recall #D-188/189-4.
CODE Lot numbers: (a) FP0326 EXP 1/95, 100's, FP0329 EXP 1/95,
30's, FP0324 EXP 1/95, 21's; (b) FP0327 EXP 2/95, 100's,
FP0330 EXP 2/95, 30's, FP0325 EXP 1/95, 21's.
MANUFACTURER Rhone Poulenc Rohrer, Manati, Puerto Rico.
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis, Missouri, by letter
December 1, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 11,660 21-tablet bottles; 10,436 100-tablet bottles,
9,981 30-tablet bottles; (b) 11,705 21-tablet bottles, 9,731
100-tablet bottles, 9,979 30-tablet bottles were
distributed.
REASON Subpotency.

_______________
PRODUCT Oxygen Cylinders, USP, in E, D, and C sized aluminum
cylinders. Recall #D-195-4.
CODE Serial number range on cylinders: 623 to 1716.
MANUFACTURER Pat Grimes, Inc., Fredericksburg, Virginia.
RECALLED BY Manufacturer, by telephone beginning February 3, 1994,
followed by letter dated February 28, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Virginia.
QUANTITY Approximately 297 cylinders were distributed.
REASON Current good manufacturing practice deficiencies.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Methocarbamol Tablets (a) 500 mg; (b) 750 mg, Rx for the
relief of acute, painful musculoskeletal conditions, under
the Schein label in bottles of 100 and 500, and under the
Danbury Pharmacal label in bottles of 500.
Recall #D-186/187-4.
CODE Lot numbers: (a) 1833C EXP 10/95, 11267C EXP 9/95, 11268C
EXP 9/95, 11269C EXP 9/95, 11270C EXP 9/95, 11271C EXP
10/95, 11825C EXP 10/95; (b) 11481C EXP 9/95, 11482C EXP
9/95, 11600C EXP 9/95, 11630C EXP 9/95.
MANUFACTURER Danbury Pharmacal, Carmel, New York.

-4-RECALLED BY Danbury Pharmacal, Brewster, New York, by letter February
17, 1994. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 16,817 100-tablet bottles and 4,675 500-tablet bottles were
distributed.
REASON Some package inserts were incompletely printed.

_______________
PRODUCT Magnesium Citrate Effervescent Laxative, 4 grams in granule
form, used for cleansing of the intestine (colon) before x-
ray and endoscopic examination. Recall #D-190-4.
CODE All lots.
MANUFACTURER PACO Pharmaceutical Services, Inc., Lakewood New Jersey
(packager).
RECALLED BY E-Z-EM, Inc., Westbury, New York (responsible firm), by
letter February 18, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Iceland, Sweden, Portugal, Ireland,
Switzerland, the Philippines.
QUANTITY 18,127 cases were distributed.
REASON Current good manufacturing practice deficiencies.

_______________
PRODUCT E-Z-Gas II Effervescent Granules Antacid/Antiflatulent,
(citric acid formula), in 4 g packets. Recall #D-191-4.
CODE All lots.
MANUFACTURER Ultra Seal Corporation, Highland, New York (packager).
RECALLED BY E-Z-EM, Inc., Westbury, New York (responsible firm), by
letter January 28, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Iceland, Sweden, Portugal, Ireland,
Switzerland, the Philippines.
QUANTITY 83,029 cases (50 packets per case) were distributed.
REASON Current good manufacturing practice deficiencies.

_______________
PRODUCT E-Z-Gas II Effervescent Granules Antacid/Antiflatulent
(tartaric acid formula), in 4 g packets. Recall #D-192-4.
CODE All lots.
MANUFACTURER E-Z-EM, Inc., Westbury, New York.
RECALLED BY Manufacturer, by letter January 28, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Iceland, Sweden, Portugal, Ireland,
Switzerland, the Philippines.
QUANTITY 3,560 cases (50 packets per case) were distributed.
REASON Current good manufacturing practice deficiencies.

_______________
PRODUCT Hydrocortisone USP Micronized, bulk powder, Rx steroid.
Recall #D-193-4.
CODE Lot #020HW and 021HW.
MANUFACTURER Upjohn Company, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter April 15, 1993. Firm-initiated
recall complete.

-5-DISTRIBUTION Undetermined.
QUANTITY 234.2 kilograms of lot 020HW and 168.2 kilograms of lot
021HW.
REASON Product was adulterated with mineral oil.

_______________
PRODUCT Aminophylline Injection, USP, 500 mg/20 ml, 20 ml single
dose vial, Rx smooth muscle relaxant. Recall #D-194-4.
CODE Lot #2312 EXP 5/95.
MANUFACTURER American Regent Laboratories, Inc., subsidiary of Luitpold
Pharmaceuticals, Inc., Shirley, New York.
RECALLED BY Manufacturer, by letter January 28, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 65,875 vials were distributed.
REASON Product does not meet specifications for ethylenediamine
content.

RECALLS AND FIELD CORRECTIONS: MEDICAL DEVICES -- CLASS II
===============

_______________
PRODUCT 9.5 French CV Catheter with Groshong Valve, Percutaneous
Placement Procedure Tray. Recall #Z-346-4.
CODE Product Code 7726954, lot #36LD6137.
MANUFACTURER Bard Access Systems, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by telephone November 22-23, 1993, and by
letter November 24, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 201 units.
REASON The firm found upon testing that the guidewires were
exhibiting a greater than acceptable level of pyrogens.

_______________
PRODUCT Howmedica Kinemax Plus Total Knee System, used for total
knee replacement orthopedic implant surgery:
Catalog No. Component
(a) 6480-0-150 Femoral, Stabilizer, non-beaded, medium;
(b) 6480-0-300 Femoral, Stabilizer, non-beaded,
extra extra large;
(c) 6471-5-271 Femoral, Condylar, non-porous, beadless,
large-right, 71 mm
(d) 6479-0-150 Femoral, Condylar, non-beaded, medium;
(e) 6479-1-250 Femoral, Condylar, beaded, extra large.
Recall #Z-351/355-4.
CODE Lot numbers: (a) CAAWB; (b) BRGKA; (c) AEWDB; (d) ALVAC,
ALVAD; (e) CFPZA, CFPZB.
MANUFACTURER Howmedica, Division of Pfizer Hospital Products group, Inc.,
Rutherford, New Jersey.
RECALLED BY Manufacturer, by telephone October 27, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.

-6-QUANTITY 60 units.
REASON Product was correctly labeled on the outside carton,
however, the device inside had a stick-on label marked
"Duracon".

_______________
PRODUCT Howmedica Duracon Universal Tibial Baseplate, Porous, Large-
2, Rose, Artificial Knee Component. Recall #Z-356-4.
CODE Catalog #6632-3-230, lot #AECXA.
MANUFACTURER Howmedica, Division of Pfizer Hospital Products Group, Inc.,
Rutherford, New Jersey.
RECALLED BY Manufacturer, by telephone June 29, 1993. Firm-initiated
recall complete.
DISTRIBUTION Alabama, Florida, Louisiana, Maine.
QUANTITY 12 pieces were distributed; firm estimates none remains on
the market.
REASON The packaging was labeled as a Duracon Universal Tibial
Baseplate but contained a Kinemax Baseplate.

_______________
PRODUCT Howmedica Kinemax Modular Tibial Baseplate, non-beaded,
medium tibial component, a sterile prosthesis.
Recall #Z-357-4.
CODE Catalog #6476-3-310, lot #BRAUA.
MANUFACTURER Howmedica, Division of Pfizer Hospital Products Group, Inc.,
Rutherford, New Jersey.
RECALLED BY Manufacturer, by telephone June 28, 1993. Firm-initiated
recall complete.
DISTRIBUTION Canada.
QUANTITY 5 pieces were distributed; firm estimates none remains on
the market.
REASON The Kinemax Tibial Baseplate was labeled as a Duracon
Universal Tibial Baseplate.

_______________
PRODUCT Webster Laboratories Fixed Curve Electrode Catheters and
Electrophysiology deflectable Catheters, used for
electrophysiology mapping of cardiac structures.
Recall #Z-398-4.
CODE The three digit sterilization code numbers are 670 through
688. Any catalog number beginning with the letter "F" or
the prefix "OF" and any catalog number in series 1080, 1084,
1085, 1086, 1087, 1088. Any catalog number beginning with
letter "D" or "OD" and any catalog number series 1078, 1079,
and 1097.
MANUFACTURER Webster Laboratories, Inc., Baldwin Park, California.
RECALLED BY Manufacturer, by letter June 25, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 4,750 units were distributed; firm estimates none remains on
the market.
-7-REASON There is a potential for some of the sealing material to be
transferred to the shaft of the catheter during the sealing
process, which may rub off during use of the catheter.

_______________
PRODUCT Datascope System 90 KNF Intra-Aortic Balloon Pump (IABP) for
use as a patient aid during pre-intra or post-operative open
heart surgery: (a) Catalog #0998-00-0010, IABP; (b) Catalog
#0998-00-0058, IABP. Recall #Z-399/400-4.
CODE Serial numbers below 3990.
MANUFACTURER Siliconix, a member of the Temic Group, Santa Clara,
California; Midwest Components, Inc., Muskegon, Michigan.
RECALLED BY Datascope Corporation, Instrumentation Division, Paramus,
New Jersey, by letter dated April 29, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, Canada, The Netherlands.
QUANTITY 1,780 were distributed.
REASON Through monitoring of service repair history and consumer
complaints, Datascope identified replacement trends
involving the power supply board and the power distribution
board. Systems subject to power board supply failures may
exhibit an inability to power up. Those subject to the
power distribution board failures may exhibit an inability
to operate from AC power.

_______________
PRODUCT Spirit, Model SP2030, coronary balloon dilatation catheter,
a percutaneous transluminal coronary artery catheter.
Recall #Z-401-4.
CODE Lot numbers: 30719B2, 30814B2, 30817B2.
MANUFACTURER Medtronic Interventional Vascular, Inc., San Diego,
California.
RECALLED BY Manufacturer, by letter November 15, 1993. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 278 units.
REASON Some labeling indicates balloon diameters are 2.0 mm instead
of 3.0 mm. This could cause inappropriate use of the
device.

_______________
UPDATE Recall #Z-733/734-3, Infusion Sets, manufactured by
Micropette, Inc., Juncos, Puerto Rico, which appeared in the
March 2, 1994 Enforcement Report should read: Firm-
initiated recall complete. This recall was completed on
November 1, 1993.

RECALLS AND FIELD CORRECTIONS: MEDICAL DEVICES -- CLASS III
==============
_______________
UPDATE Recall #Z-770-3, Matrx Centurion Mixer, which appeared in
the February 23, 1994 Enforcement Report should read:

-8- CODE: All serial numbers lack a prescription device label;
and domestic serial numbers 13314 and higher and
international serial numbers 24819 and higher contain a
typographical error on page 8 of the operations manual.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I
============
_______________
PRODUCT Phase II Horse Feed, in 50 pound bags. Recall #V-031-4.
CODE 10/20/93 - date of production.
MANUFACTURER Molinos de Puerto Rico, Inc., Hatillo, Puerto Rico.
RECALLED BY Manufacturer, by visit on or about December 16, 1993. Firm-
initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 1,840 50-pound bags were distributed.
REASON Possible cross-contamination of horse feed with monensin.

MEDICAL DEVICE SAFETY ALERTS:
=============================================
_______________
PRODUCT Matrx LifeDefense Plus (LDP) Portable
Defibrillator/Monitor/Pacer, used to provide emergency
electric (DC) defibrillation, ECG waveform monitoring and
both demand and fixed transcutaneous pacing functions.
Safety Alert #N-035-4.
CODE All serial numbers.
MANUFACTURER NEC Tochigi, Ltd., Tochigi Prefecture, Japan.
ALERTED BY Matrx Medical, Inc., Orchard Park, New York (responsible
firm), by letters dated February 1994.
DISTRIBUTION Nationwide and international.
QUANTITY 1,378 units.
REASON An error code "001" which disables the defibrillator. The
firm believes the cause of this failure to be high-impedance
discharges of the defibrillators.

-9-

END OF ENFORCEMENT REPORT FOR MARCH 16, 1994. BLANK PAGES MAY
FOLLOW.
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