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 contain s information on actions taken in connection with agency regulatory activities.

ENFORCE
07/31/1996

ENFORCEMENT REPORT FOR 07/31/96

July 31, 1996 96-31

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Rosarita brand Traditional Refried Beans, in
40.5 ounce cans. Recall #F-629-6.
CODE M650/R32.
MANUFACTURER Rosarita Foods, Company, Division Hunt-Wesson,
Inc., Mesa, Arizona.
RECALLED BY Hunt-Wesson, Inc., (HW), Fullerton,
California, by telephone on June 3 and 4,
1996, followed by letter dated June 7, 1996,
and press release on June 8, 1996. Firm-
initiated recall complete.
DISTRIBUTION California, Nevada, Arizona.
QUANTITY Approximately 3,000 cans were distributed.
REASON The product has the potential to support the
growth of Clostridium botulinum.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Sunny Delight SMOOTHIE, strawberry flavored
drink, in 64 fluid ounce plastic bottles.
Recall #F-622-6.
CODE Bottles are ink-jetted with code "SEP 26 SF"
which represents the date of expiration -
Brand code 65810, UPC code 50200-01184.
MANUFACTURER Star Specialty Foods, Sulphur Springs, Texas.
RECALLED BY The Procter & Gamble Company, Cincinnati,
Ohio, by electronic mail message sent on July
2, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Alabama.
QUANTITY 1,400 cases (8 bottles per case) were
distributed.
REASON The product contains tangerine and lime juices
which are not declared on the label.

_______________
PRODUCT Canned Mushrooms: (a) Rosa Sliced Mushrooms,
in 4 and 8 ounce cans; (b) Rosa Pieces and
Stems in 4, 8, and 16 ounce cans.
Recall #F-623/624-6.
CODE All lots.
MANUFACTURER Rosa Food Products Company, Inc.,
Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by lketter dated June 28, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION New Jersey, Pennsylvania, Delaware.
QUANTITY Undetermined.
REASON The products are contained in rusted and
detinning cans.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Encron 10 Capsules, a high lipase pancreatin
enteric coated microsphere capsule, in bottles
of 100. Recall #D-211-6.
CODE Lot #50711 EXP dates of 10/96 and 10/97.
MANUFACTURER Pegasus Laboratories, Pensacola, Florida
(repacker/responsible firm).
RECALLED BY Repacker, by telephone on or about May 16,
1996, followed by letter on May 22, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 5,980 bottles were distributed.
REASON Incorrect declaration of potency and
expiration date by repacker.

_______________
PRODUCT UDL Albuterol Sulfate Syrup, 2 mg/5mL, in 10
unit dose cups of 5 mL each, used for the
relief of bronchospasm. Recall #D-212-6.
CODE Lot #601020.
MANUFACTURER MOVA Pharmaceuticals, Caquas, Puerto Rico.
RECALLED BY UDL Laboratories, Inc., Largo, Florida
(repacker), by letter dated July 15, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.

-2-QUANTITY 355 cases of 50 unit dose cups were
distributed.
REASON Presence of Pseudomonas cepacia.

_______________
PRODUCT Valproic Acid Capsules, USP, 250 mg, packaged
in bottles of 100, anticonvulsant, under the
following labels: Chase, Pharmaceutical
Basics, Parmed, Major, Moore Drug Exchange,
Aligen, and Martec. Recall #D-213-6.
CODE Lot# 214639 EXP 8/96 (Chase Laboratories,
Inc., Pharmaceutical Basics, Inc., Parmed
Pharmaceuticals, Major Pharmaceuticals)
Lot# 147339 EXP 3/96 (Chase Laboratories,
Inc., Pharmaceutical Basics, Inc., Parmed
Pharmaceuticals, Moore Drug Exchange, Aligen
Drug Exchange, Martec Pharmaceutical Inc.,
Lot# 214739 EXP 8/96 (Chase Laboratories,
Inc., Major Pharmaceuticals, Moore Drug
Exchange.
MANUFACTURER Chase Laboratories, Inc., Newark, New Jersey.
RECALLED BY Manufacturer, by letters sent December 14 and
16, 1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Amount Shipped: 8,837 bottles of lot #214639,
9,619 bottles of lot #147339; 9,385 bottles of
lot #214739.
REASON Product does not meet disintegration test
specifications.

_______________
PRODUCT Carbamazepine Chewable Tablets, 100 mg,
packaged in bottles of 100, antiepileptic.
Recall #D-214-6.
CODE Lot numbers: 23825L and 23925L EXP 2/97.
MANUFACTURER Warner Lambert Company, Lititz, Pennsylvania.
RECALLED BY Warner Chilcott, Inc., Morris Plains, New
Jersey, by letter dated July 8, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY A total of 6,384 bottles of lot #23825L and
6,352 bottles of lot #23925L were distributed.
REASON Product does not meet content uniformity
specifications.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Imipramine Hydrochloride Tablets, USP, 10 mg,
in bottles of 100 and 1,000, Rx
antidepressant, distributed under Par's,
United Research Laboratories, Martec, and
Parmed labels. Recall #D-209-6.
-3-CODE Control #C28494 EXP 9/96.
MANUFACTURER Par Pharmaceutical, Inc., Spring Valley, New
York.
RECALLED BY Manufacturer, by letter sent on July 11, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 1,250 bottles of 100 and 279 bottles of 1,000
were distributed.
REASON Product does not meet dissolution
specifications through expiration date.

_______________
PRODUCT Nitrostat Sublingual Tablets (nitroglycerin
tablets USP), 0.3 mg, in bottles of 100,
indicated for the prophylaxis and treatment of
patients with angina pectoris.
Recall #D-210-6.
CODE Lot #00115F EXP 12/96.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis Division of Warner Lambert
Company, Morris Plains, New Jersey, by letter
on July 3, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 23,123 bottles were distributed.
REASON Potency not assured through expiration date.

_______________
PRODUCT Synthroid, Levothyroxine Sodium Tablets USP,
75 mcg, in bottles of 100, used for thyroid
replacement therapy. Recall #D-215-6.
CODE Lot #J075166 EXP 3/98.
MANUFACTURER AmeriSource Health Services, Columbus, Ohio
(repacker/responsible firm).
RECALLED BY Repacker, by electronic mail on July 16, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,608 bottles were distributed.
REASON Incorrect declaration of the mg strength.
Microgram strength is correct.
_______________
PRODUCT Minocinr (Minocycline Hydrochloride) 50 mg
Capsules, packaged in bottles of 5 (physician
samples) and unit doses of 10 x 10s, Rx
antibiotic. Recall #D-216-6.
CODE Control Numbers and EXP dates: 388-302 7/97,
399-320 11/97, 401-301 9/97, 426-431 11/97,
426-606 11/97, 426-428 11/97, 427-718 11/97,
436-038 11/97.
MANUFACTURER Wyeth-Ayerst/Lederle Laboratories, Pearl
River, New York.

-4-RECALLED BY Wyeth-Ayerst International, Inc., Division of
Wyeth-Ayerst Lederle Laboratories, St. Davids,
Pennsylvania, by letter July 23, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Hong Kong, Jordan, Malaysia, Singapore.
QUANTITY 39,818 packages were distributed.
REASON Product does not meet dissolution
specifications through expiration date.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-469-6.
CODE Unit #29130-5168.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letter dated June 7, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who
traveled to a malarial endemic area, was
distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-517-6.
CODE Unit #K06442.
MANUFACTURER Central California Blood Center, Fresno,
California.
RECALLED BY Manufacturer, by telephone on September 18,
1995. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, collected from a donor with a
medical history of malignant melanoma, was
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-518/519-6.
CODE Unit numbers: M24743, M31623, X68573, X79896,
X84251; (b) M24743.
MANUFACTURER Central California Blood Center.
RECALLED BY Manufacturer, by letter dated September 6,
1995. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY (a) 5 units; (b) 1 unit.
REASON Blood products, collected from a donor with a
history of melanoma cancer, were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-521-6.
CODE Unit #E25350.

-5-MANUFACTURER Central California Blood Center, Fresno,
California.
RECALLED BY Manufacturer, by letters dated September 15
and 22, 1995. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood products, collected from a donor
diagnosed with chronic myeloid leukemia
(cancer), were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-543/544-6.
CODE Unit #1188743.
MANUFACTURER Central Kentucky Blood Center, Lexington,
Kentucky.
RECALLED BY Manufacturer, by letter dated May 12, 1995.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor who
traveled to a malarial endemic area, were
distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-553-6.
CODE Unit #2104694.
MANUFACTURER LifeSource Blood Services, Glenview, Illinois.
RECALLED BY Manufacturer, by telephone on February 22,
1996. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, collected from directed donor
who did not meet the criteria for homologous
use, donor taking the drug, Proscar was
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Cryoprecipitated AHF; (e)
Red Blood Cells for further manufacture; (f)
Recovered Plasma. Recall #B-558/563-6.
CODE Unit numbers: (a) 1082926, 1077841, 1557789,
1067115, 7377316, 1028580, 1026584, 1025496,
1024380, 1022621, 1018843, 1017703, 1014955;
(b) 1067115, 7377316, 1025496, 1024380,
1022621, 1018843, 1017703, 1014955;
(c) 1067115, 7377316, 1018843, 1014955;
(d) 1028580, 1026584, 1017703; (e) 1090390;
(f) 1090390, 1082926, 1077841, 1557789,
1025496, 1024380, 1022621, 1028580, 1026584,
1017703.

-6-MANUFACTURER LifeSource Blood Services, Glenview, Illinois.
RECALLED BY Manufacturer, by letters dated February 1 and
6, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Illinois, Maryland, New York, Florida,
California, Switzerland.
QUANTITY (a) 13 units; (b) 8 units; (c) 4 units; (d) 3
units; (e) 1 unit; (f) 10 units.
REASON Blood products, which tested negative for
antibody to the human immunodeficiency virus
type 1 (anti-HIV 1), but collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot
negative, were distributed.

_______________
UPDATE Recall #B-469-6, Platelets, Unit #11313-1663,
which appeared in the July 10, 1996
Enforcement Report is being rescinded. The
information reported for this product is the
same as that reported for Recall #B-352-6.
Recall #B-469-6 will be reassigned to another
product.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Recovered Plasma. Recall #B-520-6.
CODE Unit numbers: M24743, M31623, X68573, X79896,
X84251.
MANUFACTURER Central California Blood Center, Fresno,
California.
RECALLED BY Manufacturer, by letter dated September 6,
1995. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 5 units.
REASON Blood products, collected from a donor with a
history of melanoma cancer, were distributed.

_______________
PRODUCT Recovered Plasma. Recall #B-522-6.
CODE Unit #E25350.
MANUFACTURER Central California Blood Center, Fresno,
California.
RECALLED BY Manufacturer, by letters dated September 15
and 22, 1995. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood products, collected from a donor
diagnosed with chronic myeloid leukemia
(cancer), were distributed.

-7-_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Platelets, Pheresis. Recall #B-531/533-6.
CODE Unit numbers: (a) 1221732, 1221751, 1221752,
4109744, 4109745, 4109748, 6196768, 6196769,
6196772, 6196776, 6196778, 6796779, 6196781,
6196782, 6196787, 6196789, 6196803, 6196807,
6196816, 6196819, 6288631, 6288655, 9126200,
9126201, 1221730, 1221737, 1221738, 1221739,
1221740, 1221743, 4806939, 4806942, 4806945,
5222014, 6196786, 6288668, 6288673, 4806943,
4806944
(b) 1221737, 6288668; (c) 3500165.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone on April 15, 1996,
and by letter April 26, 1996. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY (a) 39 units; (b) 2 units; (c) 1 unit.
REASON Blood products, incorrectly tested for
antibodies to the human immunodeficiency virus
types 1 and 2 (anti-HIV-1/2), were
distributed.

_______________
PRODUCT Red Blood Cells, Irradiated. Recall #B-564-6.
CODE Unit #2103914.
MANUFACTURER LifeSource Blood Services, Glenview, Illinois.
RECALLED BY Manufacturer, by telephone on January 5, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, labeled with an extended
expiration date, was distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I ==========
_______________
PRODUCT Allied Healthcare Bear Cub Infant Ventilator,
Model No. BP 2001, indicated for positive
pressure support of newborn and some pediatric
patients. Recall #Z-935-6.
CODE All units containing filters (Part #52000-
0209) shipped between May 1994 and May 1996
and between June 7, 1996 and June 11, 1996.
MANUFACTURER Allied Healthcare Products, Inc., Ventilation
Products Division (formerly Bear Medical
Systems, Inc.), Riverside, California.
RECALLED BY Manufacturer, by letter dated May 21, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 7,973 filters were distributed.

-8-REASON Disconnection of the purge line filter could
result in an undetected high airway pressure
caused by a combination of filter
disconnection and occlusion of the proximal
pressure line. Further, disconnection of the
PEEP/Pressure limit valve assembly filter
would stop flow of positive pressure gas. In
addition, replacement filters shipped as part
of the firm's primary recall effort, were
subsequently found to have been improperly
welded. These replacement filters can
separate during use, with the same adverse
effects as for the aforementioned filter
disconnections.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Synchron CX Quantum IV Version 4.0 Software,
for use on the CX 4CE/CX5CE/CX7 and
CX4/CX5/CX7 Delta Analyzer Systems.
Recall #Z-961-6.
CODE All version 4.0 Software.
MANUFACTURER Beckman Instruments, Inc., Brea, California.
RECALLED BY Manufacturer, by letter March 29, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 534 units were distributed.
REASON An infrequent error condition in the Synchron
CX Quantum IV (version 4.0) software may cause
a reporting error due to specimen short
sampling on the CX3 or ISE side, only. Under
certain infrequent circumstances on
instruments using Quantum IV software, sample
detection system may be compromised leading to
an incorrect, low result for one or more CX3
or ISE chemistries.

_______________
PRODUCT Maxi Slings accessories to the Maxilift
Electric Patient Lift:
(a) Large Green Border, Catalog Nos. A102124
and 102124;
(b) Extra-Large Blue Border, Catalog Nos.
A102133 and 102133. Recall #Z-978/979-6.
CODE All slings indicate on the label the product
was manufactured in Eslov, Sweden, between
February 1992 and December 1993.
MANUFACTURER Arjo AB, Eslov, Sweden.
RECALLED BY Arjo Manufacturing Company, Aurora, Nebraska,
by letters of May 31, 1996 and July 10, 1996.
Firm-initiated recall ongoing.

-9-DISTRIBUTION Nationwide.
QUANTITY 3,377 slings were distributed.
REASON The slings may beak during use, potentially
causing the patient to fall and sustain
injury.

_______________
PRODUCT Hewlett Packard Compact Patient Monitors:
(a) Model No. 78352C, Adult - Used in low risk
or short stay surgical centers;
(b) Model No. 78354C, Adult - Suitable for
medium risk or the ICU RR, or ER;
(c) Model No. 78834C, Neonate.
Recall #Z-985/987-6.
CODE Serial Numbers: (a) 3313G09294 to 3551G19231;
(b) 3314G03169 to 3543G05770;
(c) 3315G03918 to 3544G05315.
MANUFACTURER Hewlett Packard GmBH, Boblingen, Germany.
RECALLED BY Hewlett Packard Company, Andover,
Massachusetts, by letter on May 11, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Mexico, Brazil, Venezuela.
QUANTITY 387 units were distributed.
REASON The ECG board may not be able to
withstand electrostatic discharge, which may
result in a false heart rate being displayed
on the monitor, or the monitor's cardioversion
synchronization may not function.

_______________
PRODUCT Electrophysiology Catheters,used for mapping
of cardiac structures:
(a) Various electrode catheters (fixed curve
and deflectable tip catheters).
(b) A20 Diagnostic deflectable tip catheter
(c) Cordis Webster star TM catheter.
Recall #Z-992/994-6.
CODE All catheters bearing sterilization lot
numbers 800 and up and shipped through April
3, 1996.
MANUFACTURER Cordis Webster, Inc., Baldwin Park,
California.
RECALLED BY Manufacturer, by letter dated April 10, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 110,000 catheters were distributed; firm
estimated that 6,000 catheters remained on
market at time of recall initiation.
REASON The catheters are contained in pouches with
defective seals, which may compromise their
sterility.

-10-_______________
PRODUCT Bard Clean-Cath Ultra Size 16" Male/Female
Catheter, 14 FR. Recall #Z-999-6.
CODE Catalog #4A4287, Lot numbers 02BG9651 and
02CG9651.
MANUFACTURER Benlan, Inc., Oakville, Ontario, Canada
(contract manufacturer).
RECALLED BY C.R. Bard, Inc., Bard Medical Division,
Covington, Georgia, by letter sent June 3,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 24,100 units were distributed.
REASON The sterility of the device was compromised
due to improper sealing of the distal end of
the primary package.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT (a) Dade Fibrinogen Degradation (FDP)
Detection Set; (b) Dade Latex Anti-Fibrinogen
Suspension Kit, in-vitro diagnostic product
uses an immunological reacton to determine the
presence of FDP/fdp in serum or urine.
Recall #Z-990/991-6.
CODE (a) Catalog No. B4233-10, Lot Nos. FDPK-364,
FDPK-365, FDPK-366, FDPK-367;
(b) Catalog No. B4233-11, Lot Nos. LAF-285.
MANUFACTURER Dade International of Puerto Rico, Aguada,
Puerto Rico.
RECALLED BY Dade International, Inc., Miami, Florida, by
letter May 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,607 packages were distributed.
REASON Lot number LAF (a component of the FDPK set
and also sold separately) gave a false
position reaction for the negative controls.

_______________
PRODUCT Generators MPG 65/80/100 Installed with
Prestilix 1690S Remote Controlled R&F Systems:
(a) Model No. 45559622;
(b) Model No. 36002678;
(c) Model No. 36005598;
(d) Model No. 2100179. Recall #Z-995/998-6.
CODE All serial numbers installed with Prestilix
1690S Systems.
MANUFACTURER GE Medical Systems, Loncin, Belgium.

-11-RECALLED BY General Electric Company, Medical Systems
Division, Waukesha, Wisconsin, by issuing
field modification instructions on January 24,
1996. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide.
QUANTITY 11 units were distributed in the United
States.
REASON When the exposure time is less than 37
milliseconds, the spot film device sometimes
double exposes film.

-12-

END OF ENFORCEMENT REPORT FOR JULY 31, 1996. BLANK PAGES MAY FOLLOW.

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