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.

January 8, 1997 97-2

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Snack mixes in 25 pound boxes: (a) Melrose
Mix; (b) Oriental Mix; (c) Snack Mix with
Pretzels. Recall #F-161/163-7.
CODE Dates of manufacture stamped on bulk box
label: 5-1-96 to 11-4-96.
MANUFACTURER Texas Pecan Company, Dallas, Texas.
RECALLED BY Manufacturer, by letter on December 20, 1996.
Products were relabeled on November 4, 1996.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY Melrose Mix - 4450 lbs.
Oriental Mix - 3500 lbs.
Snack Mix with Pretzels - 5000 lbs.
REASON Products contain undeclared FD&C Yellow No. 5
and FD&C Yellow No. 6.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Trasylol (aprotinin injection) sterile
solution for intravenous infusion, packaged in
200 ml stoppered glass vials, used during
coronary artery bypass graft surgery.
Recall #D-073-7.
CODE Lot 6CCY EXP 11/97, 6FAH EXP 11/97, 6HAG EXP
12/97.
MANUFACTURER Bayer A.G. Leverkusen, Germany.
RECALLED BY Bayer Corporation, West Haven, Connecticut, by
letter on December 17 and 23, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 15,442 vials of lot 6CCY, 7,392 vials of lot
6FAH, and 9,882 vials of lot 6HAG were
distributed.
REASON Lack of adequate assurance of sterility.
Aluminum skirt holding vial may not be
adequately crimped in place.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Viramune (nevirapine) Tablets, 200 mg,
packaged in bottles of 100, and in unit dose
blisters of 10 cards, 10 tablets per card, Rx,
used in combination with other antiretroviral
agents for the treatment of HIV-1 infected
adults who have experienced clinical and/or
immunologic deterioration. Recall #D-061-7.
CODE Lot numbers: NS816A EXP 12/98, NS816AX EXP
12/98, NS852A EXP 1/99, NS852B EXP 7/98.
MANUFACTURER Boehringer Ingelheim Pharmaceuticals, Inc.,
Ridgefield, Connecticut.
RECALLED BY Roxane Laboratories, Inc., Columbus, Ohio
(distributor), by letter on November 22, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 13,043 bottles of 100 tablets and 380 cartons
of 10x10 blister packs were distributed; firm
estimated that 50 percent of product remained
on market at time of recall initiation.
REASON Dissolution failure (average of 74%; SPEC is
NLT 75%).

_______________
PRODUCT Oxygen, Compressed USP, transfilled into D or
E compressed medical gas cylinders.
Recall #D-062-7.
-2-CODE The following lot numbers were transfilled
during the period of 1/4/96 through 10/16/96:
3376004 33760046 3376036 3376061
6526031 3376050 33753555 3376067
3376073 3376095 6525285 65253204
3376088 3376073 3376116 3376138
3376113 3372599 3376131 3376158
3376179 0546151 0546172 6525320
3376201 3376205 0546219 3376240
3376233 3376249 3376264 3376270.
MANUFACTURER Hammer Medical Supply, Inc., Clive, Iowa.
RECALLED BY Hammer Medical Supply, Inc., Des Moines, Iowa,
by visit beginning on or about October 24,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Iowa.
QUANTITY Approximately 400 cylinders were in the field
at time of recall initiation.
REASON Lack of complete and accurate label
information (e.g. incorrect lot number).

_______________
PRODUCT PanMist S, Guaifenesin Orange-Flavored Syrup,
produced by Sage Laboratories, Inc. from
December, 1995 through April, 1996, and
packaged under the Pan American Laboratories
Label.
Recall #D-063-7.
CODE Lot numbers: SL410SU, SL411SU, SL412SU, S5002,
S5106, S6015, S6031, SL413SU, S5001, S5113.
MANUFACTURER Sage Pharmaceuticals, Inc., Shreveport,
Louisiana.
RECALLED BY Manufacturer, by fax on November 22, 1996,
followed by letter sent on November 25, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Louisiana.
QUANTITY Lot Number Packaging Size Number Bottles
SL410SU Pint Bottles 1536
SL411SU Pint Bottles 1512
SL412SU Pint Bottles 1505
S5002 Pint Bottles 1554
S5106 Pint Bottles 1260
S6015 Pint Bottles 1560
S6031 Pint Bottles 1560
10487 TOTAL
SL413SU 15 ml Sample Bottles 42552
S5001 15 ml Sample Bottles 50544
S5113 15 ml Sample Bottles 46368
139464 TOTAL.
REASON Guaifenesin may precipitate.

-3-_______________
PRODUCT Intal Inhalers, cromolyn sodium, 200 metered
dose size and 112 metered dose size, Rx, used
for management of bronchial asthma.
Recall #D-064-7.
CODE DT6G EXP 5/97 (200 metered size); CK9G EXP
5/97 EXP 5/97, CK10G EXP 6/97 (112 metered
size).
MANUFACTURER 3M Health Care (Riker Labs), Loughborough,
England.
RECALLED BY Rhone Poulenc Rorer, Collegeville,
Pennsylvania, by letter followed by
telephone. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 197,835 units were distributed.
REASON Product failed leakage rate test at the 12-
month stability testpoint due to faulty stem
diaphragm in valve.

_______________
PRODUCT Rhone-Poulenc Rorer's (a) Regroton Tablets
(Chlorthalidone, 50 mg and Reserpine, 0.25
mg); Demi-Regroton Tablets (Chlorthalidone 25
mg and Reserpine 0.125 mg), used for the
management of hypertension.
Recall #D-065/066-7.
CODE Lot numbers EXP Date
(a) MN 1399 6/30/00
MN 0845 4/30/99
MN 0653 11/30/98
MN 0489 6/30/98
MN 0179 3/31/97
MN 0178 3/31/97
MN 0084 3/31/97
MN 1611 6/30/97
(b) MN 1286 3/31/00
MN 0654 6/30/98
MN 0490 6/30/98
MN 0249 2/28/97
MN 0082 2/28/97.
MANUFACTURER Rhone Poulenc Rorer Pharmaceutical, Inc.,
Manati, Puerto Rico.
RECALLED BY Rhone Poulenc Rorer Pharmaceuticals, Inc.,
Collegeville, Pennsylvania., by letter,
followed by telephone. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 192,932 bottles were distributed.
REASON Reserpine is from an unapproved supplier.

-4-_______________
PRODUCT Cimetidine Tablets, USP, 800 mg, an oral Rx
drug used in the short-term treatment of
active duodenal ulcers or active benign
gastric ulcers, maintenance therapy for
duodenal ulcer patients at reduced dosage
after healing of active ulcers, erosive
gastroesophageal reflux disease, and the
treatment of pathological hypersecretory
conditions, packaged under the following
labels and package sizes:
i) Novopharm, in 100, 500, and 1000 tablet
bottles;
ii) Warrick Pharmaceuticals, in 100, 500, and
1000 tablet bottles. Recall #D-067-7.
CODE Lot #101981 EXP 7/98 (Note: the lot number has
various suffixes, dependent on the bottle
size).
MANUFACTURER Novopharm Ltd., Scarborough, Ontario, Canada.
RECALLED BY Novopharm USA, Inc., Schaumburg, Illinois, by
letter dated November 22, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,549 bottles of 100 tablets, 519 bottles of
500 tablets and 91 bottles of 1000 tablets
were distributed; firm estimated that very
little, if any product remained on market at
time of recall initiation.
REASON Product fails dissolution at the 3-month
stability timepoint.

_______________
PRODUCT Cytovene (Ganciclovir) Capsules, 250 mg, in
180 count bottles, used for management
treatment of cytomegalovirus virus.
Recall #D-068-7.
CODE Lot #B0088 (packaged lot B0418).
MANUFACTURER Syntex Puerto Rico, Inc., Humacao, Puerto
Rico.
RECALLED BY Hoffmann-La Roche, Inc., Nutley, New Jersey,
by telephone on July 29, 1996, followed by
letter August 1996, and telephone. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 8,000 bottles were distributed; firm estimates
none remains on the market.
REASON Product fails dissolution at the 6-month
stability timepoint (64%; SPEC is NLT 70%).

-5-_______________
PRODUCT 0.15% Potassium Chloride in 5% Dextrose and
0.45% Sodium Chloride Injection, USP, in 1000
ml infusion bags, used for the prevention or
treatment of potassium depletion.
Recall #D-069-7.
CODE J6D410 and J6D414 EXP dates 10/98.
MANUFACTURER McGaw, Inc., Irvine, California.
RECALLED BY Manufacturer, by letter dated June 18, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 44,364 units were distributed.
REASON Container label may not bear the following
red-boxed information which highlights the
concentration of potassium: "20 mEq K+/liter".

_______________
PRODUCT Zestoretic (Lisinopril & Hydrochlorothiazide)
12.5 mg Tablets, used for the management of
hypertension. Recall #D-070-7.
CODE 3657W EXP 11/1/97, 3604W EXP 11/1/97, 4135 EXP
5/1/98, 4136W EXP 11/1/98.
MANUFACTURER IPR Pharmaceuticals, Carolina, Puerto Rico.
RECALLED BY Zeneca Pharmaceuticals, Wilmington, Delaware,
by letter. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Firm estimated that 3,200 cases (307,200
blisters) remained on market at time of recall
initiation.
REASON The rear blister pack label incorrectly states
the hydrochlorothiazide potency as 25 mg. The
correct potency of 12.5 mg is also stated in
several other spots on the label.

_______________
PRODUCT Nitrostat Sublingual Tablets (Nitroglycerin
Tablets USP), Rx, indicated for the acute
relief of an attack or prophylaxis of angina
pectoris due to coronary artery disease: (a)
0.4 mg bottles of 25; (b) 0.3 mg bottles of
100. Recall #D-071/072-7.
CODE Lot numbers: 00645F EXP 3/97 (bottles of 25);
10325F EXP 1/97 (bottles of 100).
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner Lambert
Company, Morris Plains, New Jersey, letter
dated December 6, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 23,369 bottles of 25 tablets and 22,413
bottles of 100 tablets were distributed.
-6-REASON Lot 00645F failed content assay at the 18-
month stability timepoint. Lot 10325F may not
meet assay specifications through its shelf-
life.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-154-7.
CODE Unit numbers: 53FR54013, 53FR54015,
53FR54016.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by telephone on August 21, 1996.
Firm-initiated recall complete.
DISTRIBUTION Maryland and District of Columbia.
QUANTITY 3 units were distributed.
REASON Blood products were stored at an unacceptable
temperature.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-160/161-7.
CODE Unit #40FE26117.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letters dated April 19, 1996,
and May 1 and 31, 1996. Firm-initiated recall
complete.
DISTRIBUTION Illinois and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV 1), with no Western
blot performed.

_______________
PRODUCT Red Blood Cells. Recall #B-176-7.
CODE Unit #42FH38315.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated June 30, 1995.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with
a history of cancer.

_______________
PRODUCT Recovered Plasma. Recall #B-189-7.
CODE Unit numbers: 30H95505, 30G96070, 30H19540,
30G10284, 30G14890, 30H47468.

-7-MANUFACTURER American Red Cross Blood Services, Ashley,
Pennsylvania.
RECALLED BY Manufacturer, by letter dated July 19, 1995.
Firm-initiated recall complete.
DISTRIBUTION New York and Switzerland.
QUANTITY 6 units were distributed.
REASON Blood products tested negative for antibody to
the human immunodeficiency virus type 1 (anti-
HIV-1), were collected from a donor who
previously tested repeatedly reactive for
anti-HIV-1.

_______________
PRODUCT (a) Red Blood Cells; (b) Red Blood Cells,
expired; (c) Platelets; (d) Fresh Frozen
Plasma; (e) Cryoprecipitated AHF; (f) Single
Donor Plasma; (g) Recovered Plasma.
Recall #B-190/196-7.
CODE Unit numbers: 42FY13174, 2FJ39490, 42FY14464,
42L84260, 42X16113, 42Q54651, 42FK36355,
F2FJ25215, 42FY13570, 42T57814, 42L42153,
42FP10240, 42T84632, 42FZ16704, 42FJ35562,
42FJ20057, 42Q11776, 42W32247, 42S96138,
42Y32607, 42FY18011, 42X72864, 4249570,
42R96523, 42FH21494, 42FX27494, 42L07263,
42FY22239.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter sent on December 7,
1995, and January 22, 1996. Firm-initiated
recall complete.
DISTRIBUTION Ohio, Missouri, Minnesota, Florida,
California, Switzerland.
QUANTITY (a) 25 units; (b) 1 unit; (c) 8 units; (d) 1
unit; (e) 4 units; (f) 1 unit; (g) 25 units
were distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot
indeterminate.

_______________
PRODUCT Red Blood Cells. Recall #B-197-7.
CODE Unit numbers: 49J27331, 49K74362, 49K74363,
49K74364, 49K74367, 49K74372, 49K74379,
49K74380, 49K74395, 49K74405, 49K74407,
49K74409, 49K74411, 49K78897, 49K78944,
49K82062, 49K86476.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.

-8-RECALLED BY Manufacturer, by letter dated January 4, 1996.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 17 units were distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1) were subjected to
additional retesting which was negative; or
tested negative for anti-HIV-1, but were
collected from donors who previously tested
repeatedly reactive for anti-HIV-1.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-198/199-7.
CODE Unit #21F46599.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letters dated January 16 and
17, 1996. Firm-initiated recall complete.
DISTRIBUTION Oregon and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1) were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1.

_______________
PRODUCT (a) Red Blood Cells and Red Blood Cells
Deglycerolized; (b) Cryoprecipitated AHF;
(c) Recovered Plasma. Recall #B-200/202-7.
CODE Red Blood Cells, Cryoprecipitated AHF, and
Recovered Plasma Unit #21G94955; Red Blood
Cells, Deglycerolized, and Recovered Plasma,
Unit #21K93391.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letters dated January 16 and
19, 1996. Firm-initiated recall complete.
DISTRIBUTION Oregon and Switzerland.
QUANTITY (a) 1 unit each; (b) 1 unit; (c) 2 units of
each component were distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1) were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1.

_______________
PRODUCT Platelets. Recall #B-203-7.
CODE Unit #11313-5867.
MANUFACTURER United Blood Services, El Paso, Texas.
-9-RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated July 23, 1996. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed
REASON Blood product was prepared from a unit of
Whole Blood with an extended collection time.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Single
Donor Plasma. Recall #B-204/206-7.
CODE Unit #2956113.
MANUFACTURER Gulf Coast Regional Blood Center, Houston,
Texas.
RECALLED BY Manufacturer, by fax on May 31, 1996. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
admitted to high risk behavior within the last
12 months.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-207/209-7.
CODE Unit #42J64956.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letters of December 8, 1995,
July 5 and 10, 1996. Firm-initiated recall
complete.
DISTRIBUTION Ohio and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1) were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot
indeterminate.

_______________
PRODUCT (a) Red Blood Cells;(b) Platelets; (c)
Recovered Plasma. Recall #B-210/212-7.
CODE Unit #042L56615.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter on November 20, 1995.
Firm-initiated recall complete.
DISTRIBUTION Ohio, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
received a tattoo within 12 months of
donation.
-10-_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-213/214-7.
CODE Unit numbers: 49F81437, 49X30113, 49W13973.
MANUFACTURER American National Red Cross, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by letters dated March 20, 1996,
May 20, 1996, and June 26, 1996. Firm-
initiated recall complete.
DISTRIBUTION Texas, Oklahoma.
QUANTITY 3 units of each component were distributed.
REASON Blood products were collected from donors who
traveled to an area designated as endemic for
malaria.

_______________
PRODUCT Platelets, Pheresis. Recall #B-215-7.
CODE Unit #29133-9163.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letter on July 25, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area designated as endemic for
malaria.

_______________
PRODUCT (a) Red Blood Cells; (b) Red Blood Cells,
Leukocytes Removed; (c) Platelets.
Recall #B-216/218-7.
CODE Unit numbers: (a) 11314-0898; (b) 11313-5659;
(c) 11313-5659.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated August 28, 1996. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
traveled to areas designated as endemic for
malaria.

_______________
PRODUCT AS-1 Red Blood Cells. Recall #B-219-7.
CODE Unit #23132-8322.
MANUFACTURER United Blood Services, Billings, Montana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated September 9, 1996. Firm-
initiated recall complete.
DISTRIBUTION Montana.
QUANTITY 1 unit was distributed.

-11-REASON Blood product was collected from a donor who
traveled to an area designated as endemic for
malaria.

RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS III ========
_______________
PRODUCT Staphytect-OD Latex Staphylococcus Aureus
Test, for in-vitro diagnostic use,
Stock #50050. Recall #Z-196-7.
CODE Lot #103006 EXP 8/31/97.
MANUFACTURER Unipath Limited, Basingstoke, Hants, England.
RECALLED BY Orion Diagnostica, Inc., Somerset, New Jersey,
by telephone from October 18-22, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Illinois, Indiana, Missouri, Maryland, New
York, Pennsylvania, Texas, Washington state,
Wisconsin.
QUANTITY 48 kits were distributed.
REASON The reagents in the kit are deteriorating,
leading to false positive reactions with
Staphylococcus epidermidis, ATC 12228 and some
auto-agglutination.

-12-

END OF ENFORCEMENT REPORT FOR JANUARY 8, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for