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
12/14/1994
Recalls and Field Corrections: Foods -- Class II -- 12/14/1994
DECEMBER 14, 1994 94-50
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
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PRODUCT Sunnydale Farms Pina Colada Drink, in 1/2 gallon cartons.
Recall #F-132-5.
CODE Sell by Nov 16, Sell by Nov 23.
MANUFACTURER Sunnydale Farms, Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by telephone November 1 and 2, 1994, followed
by letter November 2, 1994. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 679 cases (12 cartons per case) were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
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PRODUCT Absolutely American Sparkling Water in 12 fluid ounce
bottles: (a) Strawberry flavor; (b) Peach flavor;
(c) Wild Cherry flavor; (d) Raspberry flavor.
Recall #F-128/131-5.
CODE All lots manufactured prior to May 12, 1994 with NT in the
first line of the production code.
MANUFACTURER Southwest Canners, Inc., Nacogdoches, Texas (manufacturing
plant).
RECALLED BY Sports Beverage, Inc., Plano, Texas, by letter May 19, 1994.
Firm-initiated recall complete.
DISTRIBUTION Alabama, Florida, Georgia.
QUANTITY Firm estimates none remains on the market.
REASON Product was contaminated with crickets.
_______________
PRODUCT Ghigi brand pasta bowties, in 16 ounce cellophane packages.
Recall #F-127-5.
CODE Lot numbers: L084 and L034.
MANUFACTURER Corzio Svlluppo, Morciano, Italy.
RECALLED BY Ingles Supermarkets, Black Mountain, North Carolina, by
memorandum dated August 8, 1994. Firm-initiated recall
complete.
DISTRIBUTION Southeast United States.
QUANTITY 203 cartons containing 12 packages each were distributed;
firm estimates none remains on the market.
REASON Product is contaminated with insect fragments.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
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PRODUCT Imipramine Hydrochloride Tablets, USP, 25 mg, packaged in
plastic bottles of 100, 250, and 1,000, Rx used in the
treatment of depression and childhood enuresis, under the
following labels: Par, Aligen, Goldline, Major, Martec,
Parmed. Recall #D-034-5.
CODE Lot #F11193 EXP 3/95.
MANUFACTURER Par Pharmaceuticals, Inc., Spring Valley, New York.
RECALLED BY Manufacturer, by letter and by telephone November 28, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 26,658 bottles were distributed; firm estimates almost none
of the product remains on the market.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Syn-Rx Tablets, unit dose blister packages consisting of 28
controlled-release dark blue AM tablets that contain 60 mg
pseudoephedrine HCl and 600 mg guaifenesin and 28 controlled
light green PM tablets containing 600 mg guaifenesin, and in
blister packages of 4 tablets, two AM and two PM tablets, as
physicians samples, Rx used in the treatment of sinusitis,
bronchitis, and asthma.
Recall #D-035-5.
CODE Lot numbers 4G30801 and 4G30802S (physician sample).
MANUFACTURER Packaging Coordinators, Inc., (PCI), Philadelphia,
Pennsylvania (repacker/responsible firm).
RECALLED BY Adams Laboratories, Inc., Fort Worth, Texas, by memorandums
of November 21 and 22, 1994, and by letters. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 12,224 of 14-day treatment packages, and a
minimal amount of 253,470 packages of physician samples
remained in distribution at time of recall initiation.
REASON Tablets intended for use in AM were packaged in the PM slots
and visa versa.
-2- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
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UPDATE Recall #B-046/055-5 which appeared in the November 30, 1994
should be corrected as follows: Platelets, units 15F84931,
15G32171, 15H42035, 15J33393, 15J44455, 15K15839, and
20KK02437 should be removed from B-049-5 and the total
number of units changed to 53 instead of 60 as previously
stated. Red Blood Cells, unit 15K15839 (B-047-5) should be
changed to 15KG15839, and Recovered Plasma, unit 15K15839
(B-055-5) should be changed to 15KG15839.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
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PRODUCT Lifecare PLV-102 Portable Volume Ventilator.
Recall #Z-144-5.
CODE Lot Numbers: VV940217; VV940218; VV940114; VV940117;
VV940119; VV940120; VV940122; VV940123; VV940109; VV940220;
VV940228; VV940229; VV940230; VV940219; VV940107; VV940112;
VV940132; VV940134; VV940136; VV940137; VV940201; VV940202;
VV940203; VV940204; VV940231; VV940239; VV940108; VV940111;
VV940113; VV940118; VV940115; VV940116; VV940206; VV940210;
VV940124; VV940125; VV940126; VV940127; VV940128; VV940131;
VV940106; VV940110; VV940121; VV940216; VV940222; VV940226;
VV940130; VV940211; VV940212; VV940213; VV940214; VV940215;
VV940223; VV940224; VV940225; VV940207; VV940129 plus one
unidentified unit.
MANUFACTURER Lifecare, Lafayette, Colorado.
RECALLED BY Manufacturer, by telephone, followed by letter May 3, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Florida, Virginia, Taiwan, Korea, Egypt, Brazil,
Philippines.
QUANTITY 58 units were distributed.
REASON Defective crimp joints on connectors on wire harness
assemblies, if broken could interrupt electrical continuity
in the 12 VDC ground circuit, this could cause unit to stop
and alarm go off. However, ventilator failure may cause
apnea or hypoventilation leading to permanent severe
neurologic injury.
_______________
UPDATE Recall #Z-152/159-5, which appeared in the December 7, 1994
Enforcement Report has been updated to include additional
lot numbers, an additional recall letter, expanded
distribution and quantity. The following is the complete
text of that recall:
PRODUCT Blood Cardioplegia Delivery Sets, indicated for mixing
cooling, and warming of oxygenated blood/cardioplegic
solution and delivering it to the patient:
(a) Model BCD ADV1, individually packaged in trays, 6 per
carton;
-3- (b) Model BCD ADV4, individually packaged in trays, 6 per
carton;
(c) Model BCD ADV C (with shunt), individually packaged in
trays, 6 per carton;
(d) Model D721 (BCD ADV 1 labeled for Dideco Italy),
individually packaged in trays, 6 per carton;
(e) Model D724 (BCD ADV 4 labeled for Dideco, Italy),
individually packaged in trays, 6 per carton;
(f) Model Mono 4116 (kit with BCD ADV 1 and other devices);
(g) Model Mono 3744 (kit with BCD ADV 1 and other devices);
(h) Model SCPS 3898 (kit with BCD ADV 1 and other devices).
Recall #Z-152/159-5.
CODE Lot numbers: (a) 9400234500; (b) 9400246200, 9400220700;
(c) 9400229500; (d) 9400247100, 9400226500; (e) 9400226600,
9400226700, 9400226400; (f) 9400273600; (g) 9400271200; (h)
9400256500, 9400297300.
MANUFACTURER Halkey Roberts Corporation, St. Petersburg, Florida.
RECALLED BY Sorin Biomedical, Inc., Irvine, California, by letters of
October 11, 1994, and November 28, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Alabama, California, Florida, Georgia, Louisiana, Michigan,
North Carolina, Pennsylvania, Tennessee, Texas, Washington
State, West Virginia, Arkansas, Arizona, Indiana, Minnesota,
Missouri, Nevada, New York, Ohio, South Dakota, Utah,
Virginia, Canada, Italy, Japan, The Netherlands, India.
QUANTITY 6,144 units were distributed.
REASON Due to a defective clamp on the crystalloid line, leakage
may occur, resulting in a variation of infused potassium
concentration in the crystalloid solution.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Reply Glucose Reagent, used to screen blood glucose levels
and is used on the Reply Clinical Chemistry Analyses.
Recall #Z-030-5.
CODE Lot numbers: RE179312 and RE179402.
MANUFACTURER Medical Analysis Systems, Inc., Camarillo, Canada.
RECALLED BY Olympus America, Inc., Clinical Instruments Division, Lake
Success, New York, by letter September 2, 1994, followed by
telephone. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 448 units of lot RE179402, and 431 units of lot RE179312
were distributed.
REASON The Glucose Reagent used in the Reply Clinical Chemistry
Analyzer was subpotent and will achieve an upper linearity
of 600 mg/dL instead of the labelled 700 mg/dL.
-4- _______________
PRODUCT NEV-100 Ventilators. Recall #Z-150-5.
CODE Lot numbers: NV920706, NV920707, NV920709, NV920710,
NV920718, NV920729, NV920730, NV920801, NV920804, NV920819,
NV920820, NV920823, NV920824, NV920825, NV920826, NV920903,
NV920904, NV920908, NV920909, NV920912, NV920914, NV920917,
NV920932, and NV920935.
MANUFACTURER Lifecare, Lafayette, Colorado.
RECALLED BY Manufacturer, by company bulletin dated August 1, 1994, and
by letter August 2, 1994. Firm-initiated field correction
complete.
DISTRIBUTION Minnesota, Texas, Ohio, New Jersey, Georgia, Massachusetts,
California, Arizona, Japan, Germany, China.
QUANTITY 24 units.
REASON The NEV-100 ventilator can possibly lose its internal
software program and fail to operate should the ventilator
experience a rapid succession on/off power failure or user
turning the unit on/off in rapid succession during start up.
_______________
PRODUCT 80/2 LBO Controller for Cycler Sets:
(a) Catalog #75-1112-4 - 2 Liter Cycler;
(b) Catalog #75-1122-3 - 3 Liter Cycler.
Recall #Z-161/162-5.
CODE None.
MANUFACTURER National Medical Care, McAllen, Texas.
RECALLED BY National Medical Care, Rockleigh, New Jersey, by telephone
in August 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 238 units.
REASON Cyclers lacked traceability of component parts.
_______________
PRODUCT Inflatable Penile Implant Accessory Kits and Urinary
Sphincter Prosthesis Accessory Kits:
(a) Part number 72401850, AMS 700 Inflatable Penile
Prosthesis Product Line Accessory Kit;
(b) Part Number 72401685, AMS 800/AMS Securo-T Artificial
Urinary Sphincter Prosthesis Accessory Kit.
Recall #Z-163/164-5.
CODE All devices labeled with manufacturing dates after
June 7, 1994.
MANUFACTURER American Medical Systems, Inc., Minnetonka, Minnesota.
RECALLED BY Manufacturer, by letter October 19, 1994. Recall consisted
of providing additional directions for use to avoid a
potential problem. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 2,120 kits; (b) 1,225 kits.
REASON Sutureless window connectors in the product kits may make an
improper connection or the collet prongs of the connector
may break off during the connection process.
-5- _______________
PRODUCT Novametrix Low Point Calibration Gas 5% Co2 Balance
Nitrogen, Part #8364-00, size SD Cylinder. Recall #Z-165-5.
CODE Lot #231934.
MANUFACTURER Scott Medical Products, Plumsteadville, Pennsylvania (gas).
RECALLED BY Novametrix Medical Systems, Wallingford, Connecticut, by
telephone September 30, 1994, and by fax to international
accounts. Firm-initiated recall ongoing.
DISTRIBUTION California, Louisiana, Missouri, Ohio, Pennsylvania, Italy,
Japan, Germany.
QUANTITY 74 cartons (4 units per carton) were distributed.
REASON Product is not correctly labeled, there is a discrepancy
with the Low Point Calibration Gas from lot number 231934
concerning the gas contents of the cylinder. The cylinders
are labeled to contain 5% CO2 with the balance Nitrogen, but
are in reality 5% CO2 with the balance Oxygen.
_______________
PRODUCT Stratus Digoxin Fluorometric Enzyme Immunoassay which is an
automated procedure for the quantitative determination of
digoxin levels in serum and plasma samples.
Recall #Z-170-5.
CODE Catalog #B5700-10, lot numbers: SXDI-180 through SXD6-680.
MANUFACTURER Baxter Diagnostic of PR, Inc., Aguada, Puerto Rico.
RECALLED BY Baxter Diagnostic, Inc., Miami, Florida, by letter dated
September 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Italy, Brazil, Mexico, France, Singapore.
QUANTITY 6,375 units were distributed.
REASON Defective calibrators (lots SXDI-180 through SXD6-680)
caused high control recovery values.
SEIZURES:
=================================================================
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PRODUCT Maple Syrup, Sorghum, and Honey (94-736-103).
CHARGES Adulterated - A sweetener resembling corn syrup has been
substituted wholly or in part for maple syrup, honey, and
sorghum syrup. Misbranded - The articles' labeling is false
and misleading because it represents and suggests that the
food consists entirely of maple syrup, honey, or sorghum
syrup, which representations and suggestions are contrary to
fact; the articles are offered for sale under the name of
another food, namely pure maple syrup, honey, and sorghum
syrup; the food purports to be and is represented as maple
syrup (58 and 18 case lots) and sorghum syrup (30 and 10
case lots of sorghum syrup), foods for which definitions and
standards of identity have been prescribed by regulation,
but the articles fail to meet that standard in that the
articles consist wholly or in large part of a sweetener
resembling corn syrup.
LOCATION Eagle Creek Farms, Marysville and Arlington, Washington.
-6- FILED October 24, 1994; U.S. District Court for the Western
District of Washington; Civil #C94-1587; FDC #67022.
SEIZED November 17, 1994 - goods valued at approximately $9,114.
_______________
PRODUCT Frozen Yellow-Fin Tuna Loins (95-737-665).
CHARGE Adulterated - The article consists in part of a decomposed
substance by reason of the presence of decomposed fish.
LOCATION Cityice Cold Storage Company, Seattle, Washington.
FILED November 23, 1994; U.S. District Court for the Western
District of Washington; Civil #C94-1745WD; FDC #67033.
SEIZED December 1, 1994 - goods valued at approximately $80,000.
-7-
END OF ENFORCEMENT REPORT FOR DECEMBER 14, 1994. BLANK PAGES MAY
FOLLOW.
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