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
02/26/1992
Recalls and Field Corrections: February 26, 1992
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: (a) Frozen Razor Clams in 5 pound cans; (b) Minced Razor
Clams, in 7 ounce cans. Recall #F-116/117-2.
Code: (a) All lots produced since 9/1/91; (b) Lot #01118/BMRCL.
Manufacturer: Bell Buoy Crab Company, Seaside, Oregon.
Recalled by: Manufacturer, by telephone November 21-22, 1991.
Firm-initiated recall complete.
Distribution: Washington state, Oregon, California, Virginia, Idaho.
Quantity: (a) 591 cans; (b) 96 cans were distributed.
Reason: Product is contaminated with Domoic Acid.
----
-1-
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.
Product: Mehaffies brand (a) Pineapple Pie; (b) Lemon Pies,
32 ounces. Recall #F-120/121-2.
Code: Pies coded with a pull date that expires 4 days from
the date of manufacture.
Manufacturer: Mehaffies Pie Company, Dayton, Ohio.
Recalled by: Manufacturer, by visit July 11, 1991. Firm-initiated
recall complete.
Distribution: Ohio.
Quantity: Approximately (a) 80 pies; (b) 300 pies were distributed;
none remains on market.
Reason: Product contained undeclared FD&C Yellow No. 5.
----
Product: Birds Eye Brussels Sprouts, in 10 ounce foil wrapped
boxes. Recall #F-122-2.
Code: Lot numbers NI0348 5, NI0348 6, NI0348 7.
Manufacturer: Norcal Crosetti Foods, Inc., Watsonville, California.
Recalled by: Kraft General Foods, Inc., Glenview, Illinois, by letter
January 23, 1992. Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: 1,515 cases (24 boxes per case) were distributed; firm
estimates 30 percent remains on the market.
Reason: Product is contaminated with diesel fuel.
----
Product: Kountry Fresh brand (a) Shelled Peanuts; (b) Roasted
Peanuts, in 16 ounce glass jars. Recall #F-123/124-2.
Code: Sell by 5-5-93B.
Manufacturer: John B. Sanfilippo & Son, Inc., Bainbridge, Georgia.
Recalled by: Manufacturer, by visit on or about January 31, 1992.
Firm-initiated recall ongoing.
Distribution: Alabama.
Quantity: Unknown.
Reason: Product contains high aflatoxin levels.
----
Product: Fresh Asparagus imported from Peru, in unlabeled 11
pound cartons. Recall #F-125-2.
Code: None.
Manufacturer: Frutech International Pompnao Beach, Florida.
Recalled by: Manufacturer, by telephone November 20, 1991, followed
by letter November 21, 1991. Firm-initiated recall
complete.
-2-
Distribution: Florida, Michigan, New York, Georgia.
Quantity: 392 cartons were distributed; firm estimates none
remains remain on the market.
Reason: Product is contaminated with Chlorpyrifos.
----
Product: Blended Margarine and Butter Products:
(a) TW Services, 1 pound containers;
(b) Gold-N-Sweet, 5 pound tubs;
(c) Old Fashion, 20 pound pails;
(d) One + Two (1+2), 1 pound containers, and 5 and
50 pound pails;
(e) Fancy Blend, 30 and 50 pound cubes.
Recall #F-127/131-2.
Code: All lot codes that include the letters "CW".
Manufacturer: Wilsey Foods, Inc., City of Industry, California.
Recalled by: Manufacturer, by telephone November 12, 1991 and by
press release issued by the State of California,
Department of Health Services on November 14-15, 1991.
Firm-initiated recall ongoing.
Distribution: Arizona, California, Hawaii, Nevada, Utah.
Quantity: Approximately 1,660,000 pounds were manufactured;
FDA estimates that little product remains in commerce.
Reason: Product is contaminated with Staphylococcus enterotoxin.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
CORRECTION: Bottled Water, Recall #F-112-2, manufactured by
Cascade Clear Water Company, Sedro Wooley, Washington,
which appeared in the January 29, 1992 Enforcement
Report is a Class III recall.
----
COSMETICS
Class I -
NONE
Class II -
Product: Hand Lotion, non-medicated, in 12 fluid ounce plastic
pump bottles. Recall #F-126-2.
Code: Lot numbers: MG0390, MG1190, MG1290, MG1390, MH0190
MH0290, MH0990, MH1090, MH1790, MH2090, MH2190.
Manufacturer: Midik Corporation, Elkhart, Indiana.
-3-
Recalled by: Bristol-Myers Squibb Company, Evansville, Indiana, by
voice mail message on October 25, 1991, followed by
sales department bulletin dated October 30, 1991, and
by letter October 31, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 84,660 bottles were distributed; firm estimates none
remains on the market.
Reason: Product is contaminated with Pseudomonas Aeruginosa.
----
Class III -
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: LyphoMed brand Nitroglycerin Injection, USP, 5 mg/ml, in
5 ml and 10 ml vials, a Rx injectable for intravenous
infusion after dilution for control of blood pressure
during surgical procedures. Recall #D-214-2.
Code: Lot numbers: 110359 EXP 10/92 (5 ml), 110367 EXP 10/92
(10 ml).
Manufacturer: Lyphomed, Division of Fujisawa USA, Inc., Melrose Park,
Illinois.
Recalled by: Manufacturer, by letter February 7, 1992. Firm-initiated
recall ongoing.
Distribution: Florida, New York, California, New Jersey, Puerto Rico,
India.
Quantity: 24,250 5-ml vials and 15,720 10-ml vials were distributed;
firm estimates none remains on the market.
Reason: Subpotency.
----
Product: Levothroid (Levothyroxin Sodium, USP) Tablets, 100 mcg,
in 100 tablet bottles, a Rx product used as a replacement
for substitution therapy for diminished or absent thyroid
function. Recall #D-216-2.
Code: 05428-1 EXP 4/93.
Manufacturer: Pharmacy Dispensing Quantities, Inc., Fort Scott, Kansas.
(repacker/responsible firm).
Recalled by: Repacker, by letter December 23, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 1,498 bottles were distributed.
Reason: An Inderal 10 mg tablet was found in a bottle of the
product.
----
-4-
Product: OTC Acetaminophen Liquid, cherry and grape flavors, in
4 fluid ounce plastic bottles, with accompanying dosage
cup, indicated for relief of children's fever and pain,
under the K.C. Pharmaceuticals, Leiner Nutritional
Products, and Topco Associates labels. Recall #D-219-2.
Code: Lot numbers 9B21401, 9C21402, 9F21403, 9F21404, 0A025,
0E048, OK018, 0M016, 0N029, 1D033, 1D035, EXP dates range
from 3/91 to 11/92.
Manufacturer: K.C. Pharmaceuticals, Inc., Pomona, California.
Recalled by: Manufacturer, by letter January 10, 1992. Firm-initiated
recall ongoing.
Distribution: California, Illinois.
Quantity: 81,822 bottles were distributed; FDA estimates 8,000
bottles remain on the market.
Reason: Markings on dosage cup not totally compatible with label
dosage instructions.
----
Product: Platelets Pheresis. Recall #B-121-2.
Code: Unit numbers: 21P27268, 21P27270, 21P27273S, 21P27274S,
21P27274T.
Manufacturer: American Red Cross, Portland, Oregon.
Recalled by: Manufacturer, by telephone June 6, 1991, followed by
letter June 21, 1991. Firm-initiated recall complete.
Distribution: Oregon.
Quantity: 5 units.
Reason: Blood products, labeled with incorrect expiration dates,
were distributed.
----
Product: Recovered Plasma. Recall #B-128-2.
Code: Unit #53R77805.
Manufacturer: American Red Cross Blood Services, Baltimore, Maryland.
Recalled by: Manufacturer, by letter June 26, 1991. Firm-initiated
recall complete.
Distribution: Switzerland.
Quantity: 1 unit.
Reason: Blood product drawn from an unsuitable donor was
distributed.
----
Product: Red Blood Cells. Recall #B-130-2.
Code: Unit #1390990.
Manufacturer: Mississippi Blood Services, Inc., Jackson, Mississippi.
Recalled by: Manufacturer, by telephone October 17, 1991, followed
by letter November 14, 1991. Firm-initiated recall
complete.
Distribution: Mississippi.
-5-
Quantity: 1 unit.
Reason: A unit of red blood cells, testing repeatably reactive
for the antibody to hepatitis C virus encoded antigen
(anti-HCV), was distributed.
----
Product: Red Blood Cells. Recall #B-131-2.
Code: Unit #1678135.
Manufacturer: Walson Army Hospital, Ft. Dix, New Jersey.
Recalled by: Manufacturer, by telephone September 26 or 27, 1991.
Firm-initiated recall complete.
Distribution: New York.
Quantity: 1 unit.
Reason: Blood component which tested repeatably reactive for
hepatitis B surface antigen (HBsAg) was distributed for
transfusion.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma; (d) Recovered Plasma. Recall #B-135/138-2.
Code: Unit numbers: 21-54448, 21-58709, 21-62534, 21-64150,
21-66371, 21-68787, 21-69882, 21-75061, 21-85046, 21-87455,
21-90189, 35-17567, 35-20290, 35-22115, 35-25034, 35-37562,
35-39564, 35-45190, 35-57740, 35-58126, 35-69974, 35-72033,
35-77937, 35-78390, 35-79838, 35-87387, 35-94708, 35-99103,
37-01509, 37-01906, 37-05957, 37-06798, 37-13446, 37-24155,
37-29406, 37-31288;
(b) 35-17567, 35-20290, 35-22115, 35-39564, 35-57740,
35-58126, 35-69974, 35-72033, 35-79838, 35-78390, 35-87387,
35-94708, 35-99103, 37-01509, 37-01906, 37-05957, 37-06798,
37-13446, 37-24155, 37-29406, 37-31288;
(c) 21-85046, 35-20290, 35-37562, 35-76782, 37-01906;
(d) 21-54448, 21-58709, 21-62534, 21-64150, 21-66371,
21-68787, 21-69882, 21-75061, 21-87455, 21-90189, 35-17567,
35-22115, 35-25034, 35-39564, 35-45190, 35-57740, 35-58126,
35-69974, 35-72033, 35-77937, 35-78390, 35-79838, 35-87387,
35-94708, 35-99103, 37-01509, 37-05957, 37-06798, 37-13446,
37-24155, 37-29406, 37-31288.
Manufacturer: Michigan Community Blood Center, doing business as
Grand Valley Blood Program, Grand Rapids, Michigan.
Recalled by: Manufacturer, by telephone November 1, 1990, and by
letters of January 2, 7 and 14, 1991. Firm-initiated
recall ongoing.
Distribution: Mississippi, Virginia, New York, California, New Jersey,
Pennsylvania, Michigan.
Quantity: (a) 36 units; (b) 21 units; (c) 5 units; (d) 32 units.
Reason: Blood components, which tested non-reactive for the
antibody to the human immunodeficiency virus type 1
(anti-HIV-1) but were collected from donors who
previously tested repeatably reactive for anti-HIV-1,
were distributed.
----
-6-
Product: Source Plasma. Recall #B-145-2.
Code: Unit #XF9880.
Manufacturer: Indianapolis Blood Plasma, Inc., Indianapolis, Indiana.
Recalled by: Consignee notified firm October 8, 1991. Recall complete.
Distribution: North Carolina.
Quantity: 1 unit.
Reason: Blood product untested for the antibody to the human
immunodeficiency virus type 1 (anti-HIV-1) and hepatitis B
surface antigen (HBsAg) was distributed.
----
Product: Platelets, Pooled. Recall #B-147-2.
Code: Pool #FF63382.
Manufacturer: The Blood Center of Southeastern Wisconsin, Milwaukee,
Wisconsin.
Recalled by: Manufacturer, by telephone July 25, 1991. Firm-initiated
recall complete.
Distribution: Wisconsin.
Quantity: 1 unit.
Reason: Pooled Platelets, which contained platelets collected
from an ineligible donor due to a reported history of
hepatitis b exposure occurring two weeks prior to
donation, were distributed.
----
Class III -
Product: Rx Tylenol with Codeine No. 3 Tablets, in 100 tablet
bottles. Recall #D-215-2.
Code: Lot #HC1632P EXP 3/94.
Manufacturer: McNeil Pharmaceutical Company, Dorado, Puerto Rico.
Recalled by: McNeil Pharmaceutical, Spring House, Pennsylvania,
by letter January 20, 1992. Firm-initiated recall ongoing.
Distribution: New York, Pennsylvania, Florida, Virginia, Maryland,
Georgia, Alabama, West Virginia, South Carolina, Rhode
Island, Connecticut, North Carolina, Maine, Vermont.
Quantity: 13,680 bottles were distributed; firm estimates 1,000
bottles remain on the market.
Reason: Some bottles in correctly labeled unit cartons were
placed in a packer labeled Tylenol with Codeine No. 2
tablets. The outer shipping carton is correctly labeled.
----
Product: Trandate (Labetalol Hydrochloride) Tablets, 100 mg, in
100 tablet bottles, a Rx drug for use in the management
of hypertension. Recall #D-217-2.
Code: Z60300MX EXP MAY94.
Manufacturer: Pharmacy Dispensing Quantities, Inc., Ft. Scott, Kansas
(repacker/responsible firm).
-7-
Recalled by: Repacker, by letter August 13, 1991. Firm-initiated
recall complete.
Distribution: New York, Missouri, Tennessee, South Dakota, Idaho,
Ohio, Pennsylvania, Indiana.
Quantity: 140 bottles were distributed.
Reason: The label correctly declares the product as 100 mg
but the ingredient statement shows the product as 200 mg.
----
Product: Clonidine HCl Tablets, 0.3 mg, in 100 tablet bottles, a
Rx drug indicated for the treatment of hypertension,
under the Best label only. Recall #D-218-2.
Code: Lot numbers 322991 EXP 8/93, 127491 EXP 9/93.
Manufacturer: Par Pharmaceutical, Inc., Spring Valley, New York.
Recalled by: Manufacturer. Firm-initiated recall ongoing.
Distribution: Florida.
Quantity: 72 bottles were distributed.
Reason: Correct tablet number 112 was misprinted as 110 on the
side panel of the Best brand label.
----
Product: (a) Platelets Pheresis; (b) Source Leukocytes.
Recall #B-119/120-2.
Code: Unit numbers: (a) 21P27407, 21P27409; (b) 21F12431.
Manufacturer: American Red Cross, Pacific Northwest Services,
Portland, Oregon.
Recalled by: Manufacturer, by letter June 24, 1991. Firm-initiated
recall complete.
Distribution: Oregon, Washington state.
Quantity: (a) 2 units; (b) 1 unit.
Reason: Blood products, incorrectly tested for the antibody
to the hepatitis C virus (anti-HCV), were distributed.
----
Product: Red Blood Cells. Recall #B-129-2.
Code: Unit numbers: 5161923 through 5161930, 5161932, 5161933,
5161935, 5161936, 5161939, 5161944, 5161946, 5161949,
5161950, 5161951.
Manufacturer: Department of the Navy, Naval Hospital Camp Lejeune,
Camp Lejeune, North Carolina.
Recalled by: Manufacturer, by telephone August 28-29, 1991. Firm-
initiated recall complete.
Distribution: North Carolina, New Jersey.
Quantity: 18 units.
Reason: Red Blood Cells labeled with incorrect expiration
dates were distributed.
----
-8-
Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma;
(d) Fresh Frozen Plasma; (e) Cryoprecipitated AHF.
Recall #B-139/143-2.
Code: Unit numbers: (a) 21-65779, 21-75172, 32-67143, 35-34999,
35-39374, 35-39472, 35-40820, 35-42151, 35-45886, 35-47282,
35-50970, 35-51753, 35-52477, 35-53952, 35-53986, 35-55003,
35-56697, 35-59369, 35-60827, 35-64630, 35-65208, 35-71771,
35-73412, 35-76782, 35-76793, 35-77105, 35-77285, 35-77492,
35-82167, 35-87288, 35-89389, 35-89831, 35-91751, 35-94573,
35-95222, 35-96137, 35-97931, 35-01399, 37-02147, 37-05105,
37-10576, 37-12827, 37-16040, 37-16873, 37-20114, 37-21703,
37-22351, 37-26799, 37-27245, 37-30921, 37-33717, 37-36371,
37-36838, 37-37409, 41-09170, 41-10558, 41-11004, 41-11898,
41-11946, 41-12982, 41-12989, 41-15625;
(b) 32-67143, 35-34999, 35-39374, 35-39472, 35-40820,
35-42151, 35-45886, 35-47282, 35-50970, 35-51753, 35-52477,
35-53952, 35-53986, 35-55003, 35-56697, 35-59369, 35-60827,
35-64630, 35-65208, 35-71771, 35-73412, 35-76782, 35-76793,
35-77105, 35-77285, 35-82167, 35-87288, 35-89389, 35-91751,
35-94573, 35-95222, 35-96137, 37-01399, 37-02147, 37-05105,
37-10576, 37-12827, 37-16040, 37-16873, 37-20114, 37-22351,
37-26799, 37-27245, 37-33717, 37-36371, 37-37409, 41-11004,
41-11898, 41-11946, 41-12989;
(c) 21-65779, 21-75172, 32-67143, 32-67287, 35-39374,
35-39472, 35-40820, 35-45866, 35-50970, 35-51753, 35-52477,
35-53952, 35-53986, 35-56697, 35-60827, 35-64630, 35-65208,
35-71771, 35-73412, 35-76793, 35-77105, 35-77285, 35-77492,
35-82167, 35-89389, 35-89831, 35-91751, 35-94573, 35-95222,
35-96137, 35-97931, 37-01399, 37-12827, 37-16040, 37-16873,
37-21703, 37-22351, 37-26799, 37-27245, 37-30921, 37-33717,
37-36838, 41-09170, 41-10558, 41-11004, 41-11898, 41-11946,
41-12982, 41-12989, 41-15625;
(d) 35-34999, 35-42151, 35-47282, 35-55003, 35-59369,
35-87288, 35-02147, 37-05105, 37-10576, 37-20114, 37-36371,
37-37409;
(e) 35-89831, 35-97931, 35-21703, 37-30921, 37-36838,
41-11004, 41-11898, 41-12982.
Manufacturer: Michigan Community Blood Center, doing business as
Grand Valley Blood Program, Grand Rapids, Michigan.
Recalled by: Manufacturer, by telephone November 1, 1990, and by
letters of January 2, 7, and 14, 1991. Firm-initiated
recall ongoing.
Distribution: Mississippi, Virginia, New York, California, New Jersey,
Pennsylvania, Michigan.
Quantity: (a) 62 units; (b) 50 units; (c) 50 units; (d) 12 units;
(e) 8 units.
Reason: Blood components, which tested non-reactive for the
antibody to the human immunodeficiency virus type 1
(anti-HIV-1) but were collected from donors who
previously tested repeatably reactive for anti-HIV-1,
were distributed.
----
-9-
Product: Source Plasma. Recall #B-144-2.
Code: Unit #52396.
Manufacturer: Sera-Tec Biologicals, Inc., Toledo, Ohio.
Recalled by: Consignee notified firm on or about July 10, 1991.
Recall complete.
Distribution: Michigan.
Quantity: 1 unit.
Reason: Blood products from two different donors were
labeled with identical bleed numbers and released.
----
Product: Red Blood Cells. Recall #B-146-2.
Code: Unit #6035521.
Manufacturer: Community Blood Center, Inc., Appleton, Wisconsin.
Recalled by: Consignee notified firm by telephone December 31, 1991.
Recall complete.
Distribution: Kentucky.
Quantity: 1 unit.
Reason: A unit of Red Blood Cells, labeled with the incorrect
expiration date, was distributed.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
CORRECTION: Recall #Z-295-2, which appeared in the February 12, 1992
Enforcement Report should read:
Product: Externally Assembled Lower Limb Prosthesis, AKA, Above
Knee Prosthesis Appliance/Artificial Leg. Only those
units manufactured using the Teh Lin above the knee wood
block, TWB-4 series are involved. Only units manufactured
from 1/91 through 10/91 may contain this component. This
is a custom device that is labeled: Harry J. Lawall & Son,
Philadelphia, Pennsylvania. Recall #Z-295-2.
Reason: The Teh Lin above the knee wood block, TWB-4 series
component appeared to be fracturing while in use and
may cause a severe malalignment of the leg components.
----
-10-
Class III -
Product: ZMS IM Fixation Tibial Nails, orthopedic implant products
used in fracture fixation of the tibia:
1. Catalog No. 2238-09-40, 9mm diameter and 40cm length
2. Catalog No. 2238-09-42, 9mm diameter and 42cm length
3. Catalog No. 2238-09-44, 9mm diameter and 44cm length
4. Catalog No. 2238-10-40, 10mm diameter and 40cm length
5. Catalog No. 2238-10-42, 10mm diameter and 42cm length
6. Catalog No. 2238-10-44, 10mm diameter and 44cm length
7. Catalog No. 2238-11-40, 11mm diameter and 40cm length
8. Catalog No. 2238-11-42, 11mm diameter and 42cm length
9. Catalog No. 2238-11-44, 11mm diameter and 44cm length
10. Catalog No. 2238-12-40, 12mm diameter and 40cm length
11. Catalog No. 2238-12-42, 12mm diameter and 42cm length
12. Catalog No. 2238-12-44, 12mm diameter and 44cm length
13. Catalog No. 2238-13-40, 13mm diameter and 40cm length
14. Catalog No. 2238-13-42, 13mm diameter and 44cm length
15. Catalog No. 2238-13-44, 13mm diameter and 44cm length
16. Catalog No. 2238-14-40, 14mm diameter and 40cm length
17. Catalog No. 2238-14-42, 14mm diameter and 42cm length
18. Catalog No. 2238-14-44, 14mm diameter and 44cm length
Recall #Z-323/340-2.
Code: Lot numbers:
(1) 78262100; (2) 78262200; (3) 78262300; (4) 77691500;
(5) 77691600; (6) 77691700; (7) 78610600; (8) 78610700;
(9) 78610800; (10) 78734300; (11) 78734200; (12) 78734100;
(13) 77963900; (14) 77964000; (15) 77964100; (16) 7808900;
(17) 708089000; (18) 78089100.
Manufacturer: Zimmer, Inc., Warsaw, Indiana.
Recalled by: Manufacturer, by letter December 23, 1991. Firm-initiated
recall ongoing.
Distribution: Kentucky, New Jersey, Connecticut, Wisconsin, Virginia,
Mississippi, California, South Carolina, Ohio.
Quantity: 76 pieces were distributed.
Reason: The tibial nails have light green stickers that code for
femoral nails instead of the correct black stickers for
tibial nails.
----
VETERINARY PRODUCTS
NONE
-11-