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
08/25/1993
Recalls and Field Corrections: Foods -- Class I -- 08/25/1993
AUGUST 25, 1993
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
=========================
_______________
PRODUCT Snow/Centollon Crabmeat, cooked, frozen, in 5 pound boxes.
Recall #F-488-3.
CODE 176 on cases received from Chile.
MANUFACTURER Pesquera Torres Del Paine, Santiago, Chile.
RECALLED BY Interamerican Trading and Products Corporation, Miami,
Florida, by letter June 7, 1993. Firm-initiated recall
complete.
DISTRIBUTION Florida, Minnesota.
QUANTITY 660 pounds were distributed.
REASON The product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Various sandwiches containing roast beef or turkey, under
Mrs. Drake's and or Good 'n Fresh labels:
(a) Sliced Turkey Sandwich, 3-1/2 ounces;
(b) Turkey, Lettuce and Tomato Sandwich, 5 ounces;
(c) Roast Beef Sandwich, 3-3/4 ounces, 4-1/2 ounces;
(d) Roast Beef Dressed Sandwich, 3-1/2 ounces ;
(e) Roast Beef and Gravy Sandwich, 6 ounces;
(f) Roast Beef, Lettuce, and Tomato Sandwich, 5 ounces;
(g) Turkey Sandwich, 3-3/4 ounces;
(h) Triple Treat Sandwich, 3-3/4 ounces.
Recall #F-562/569-3.
CODE Products coded on or before 5/15/93.
MANUFACTURER Mrs. Drake's Sandwiches, New Orleans, Louisiana.
RECALLED BY Manufacturer, by memorandum May 17, 1993. Firm-initiated
recall complete.
DISTRIBUTION Louisiana.
QUANTITY Undetermined.
REASON The product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Fresh Crabmeat, in 16 ounce plastic containers with plastic
snap-on lids: (a) Jumbo Lump Crabmeat; (b) Backfin
Crabmeat; (c) Claw Crabmeat. Recall #F-570/572-3.
CODE 1383.
MANUFACTURER Craven Crab Company, Inc., New Bern, North Carolina.
RECALLED BY Manufacturer, by letter May 28, 1993. Firm-initiated recall
complete.
DISTRIBUTION North Carolina, Maryland, Pennsylvania.
QUANTITY (a) 279 pounds; (b) 615 pounds; (c) 9 pounds were
distributed.
REASON Products were contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
========================
_______________
PRODUCT New Direction Nutritional Beverage Powders: (a)
Chocolate/Fiber Nutritional Beverage in 2.05 ounce packets,
7 packets per box, 12 boxes per case; (b) Vanilla
Nutritional Beverage, in 1.76 ounce packets, 7 packets per
box, 12 boxes per case. Recall #F-526/527-3.
CODE (a) 77659T300 DEC 94; (b) 77658T300 DEC 94.
MANUFACTURER Maple Island, Inc., Stillwater, Minnesota.
RECALLED BY Ross Laboratories, Inc., Columbus, Ohio, by telephone and by
letter June 28, 1993. Firm-initiated recall ongoing.
DISTRIBUTION (a) Nationwide; (b) Alabama, California, Illinois, Maryland,
Minnesota, North Carolina, New Jersey, Oklahoma,
Pennsylvania, Washington state.
QUANTITY (a) 476 cases; (b) 251 cases were distributed.
REASON FDA analyses found a sample of the New Direction
Chocolate/Fiber Nutritional Beverage Powder to be
contaminated with Salmonella and both products were
manufactured under conditions whereby they may have become
contaminated by Salmonella.
_______________
PRODUCT Gerber 2nd Foods brand Oatmeal with applesauce and bananas
baby food, in 4 ounce glass jars. Recall #F-560-3.
CODE 20JAN95/469F**** (**** represents the time of manufacture).
MANUFACTURER Gerber Products Company, Fremont, Michigan.
RECALLED BY Manufacturer, by letter April 29, 1993, and by visits of May
4 and 7, 1993. Firm-initiated recall complete.
DISTRIBUTION Connecticut, Indiana, Illinois, Kentucky, Massachusetts,
Michigan, Minnesota, North Dakota, New York, Ohio,
Pennsylvania, Rhode Island, Vermont, Wisconsin.
-2- QUANTITY 25,590 cases were distributed.
REASON Product contained glass particles.
_______________
PRODUCT Jubilee Trail Mix, Dried Fruit Mix, in 16 pound boxes.
Recall #F-561-3.
CODE AUG 10 1992 and AUG 25 1992 stamped on boxes. Product
#30831.
MANUFACTURER Jason & Son, Rancho Cordova, California.
RECALLED BY Manufacturer. All remaining product was returned to firm on
or about November 23, 1992. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 49 were distributed; Recall is complete and product has been
relabeled.
REASON Product contains undeclared sulfites.
RECALLS AND FIELD CORRECTION: DRUGS -- CLASS II
=========================
_______________
PRODUCT Scandonest 3% Plain (Mepivacaine Hydrochloride) Injection,
USP, a dental anesthetic in cartridges packed in vacuum
cans, 50 cartridges per can. Recall #D-322-3.
CODE Lot # 2B3138 EXP 6/95.
MANUFACTURER Specialities Sepodont, Paris, France.
RECALLED BY Deproco, Inc., New Castle, Delaware, by telephone August 9
and 10, 1993, followed by letter August 11, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 142,000 cartridges were distributed.
REASON Some cans labeled Scandonest Cartridges contain Isocaine 2%
cartridges.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
=======================
_______________
PRODUCT (a) Ether, USP; (b) Ether for Anesthesia, USP.
Recall #D-319/320-3.
CODE Lot numbers and sizes: (a) D45626 -- 1 L., 4 L., 320 lbs;
F39638 -- 4 L.; G10601, G22655, G27659 -- 1 L., 4 L;
(b) D45629 -- 250 ml, 1 L.; D50631 -- 250 ml;
E16604 -- 150 ml, 250 ml, 1 L; E28605 -- 250 ml, 1 L,
E38640 -- 1 L, E45633 -- 150 ml, 250 ml, 1 L; E51627 -- 150
ml, 250 ml, 1 L; F03623 -- 150 ml, 250 ml, 1 L, F39641 --
150 ml, 250 ml, 1 L; F52610 -- 150 ml, G05648 -- 1 L,
G10604 -- 1 L, G22658 -- 150 ml, 250 ml, 1 L;
Ethyl Ether for Anesthesia, Fisher label: 905778 -- 150 ml,
1 L, 905790 -- 150 ml, 1 L; 912843 -- 150 ml, 1 L,
913432 -- 1 L, 913819 -- 150 ml, 1 L; 914018 -- 150 ml, 1 L,
915663 -- 150 ml, 1 L, 920052 -- 1 L, 922858 -- 150 ml, 1 L,
922860 -- 150 ml, 1 L, 923072 -- 150 ml, 925548 -- 150 ml,
-3- 925549 -- 150 ml; 925550 -- 150 ml. Under the labels J.T.
Baker and Fisher Scientific.
MANUFACTURER J.T. Baker, Inc., Jackson, Tennessee (repacker/responsible
firm).
RECALLED BY J.T. Baker, Inc., Phillipsburg, New Jersey, by letter August
6, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, international.
QUANTITY (a) 415 packages (all sizes); (b) 7,566 packags (all sizes)
remained in commerce at the time of recall initiation.
REASON Products do not meet USP peroxide specification.
_______________
PRODUCT Enteric Coated Aspirin Tablets, 325 mg, (5 gr) in 100, 200,
and 1000 size bottles, under the following labels: J.J.
Balan, C.S. Ruckstuhl Co., Inc., Reyman Drug Co., Inc.
Recall #D-321-3.
CODE Lot numbers: IB-1021 EXP 2/94, HF-1045 EXP 6/93, HD-1033 EXP
4/93, HD-1032 EXP 4/93, HC-1020 EXP 3/93.
MANUFACTURER Royce Laboratories, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter February 23, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 2,000,000 tablets from each lot were distributed.
REASON Product does not meet dissolution specification.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
====================
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Platelets;
(d) Cryoprecipitated AHF; (e) Fresh Frozen Plasma; (f) Red
Blood Cells for Further Manufacture; (g) Platelets for
Further Manufacture; (h) Source Leukocytes for Further
Manufacture; (i) Recovered Plasma. Recall #B-361/369-3.
CODE (a) 31C65806 and 31E49329;
(b) 31C00215, 31C01348, 31C01437, 31C02593, 31C03496,
31C04682, 31C04715, 31C05582, 31C05848, 31C06778, 31C09120,
31C09937, 31C11953, 31C12338, 31C14941, 31C17896, 31C18513,
31C18830, 31C20723, 31C21119, 31C22901, 31C23680, 31C26033,
31C50147, 31C50160, 31C51901, 31C52720, 31C53356, 31C54698,
31C55238, 31C55442, 31C56483, 31C57060, 31C57564, 31C58308,
31C60467, 31C64054, 31C65077, 31C66985, 31C67645, 31C68818,
31C69793, 31C70340, 31C71810, 31C73428, 31C75015, 31C75022,
31C76455, 31C76481, 31C78195, 31C78593, 31C81410, 31C82623,
31C83297, 31C83935, 31C84986, 31C86640, 31C87242, 31C89148,
31C90821, 31C91584, 31C92940, 31C94669, 31C95197, 31C96411,
31C98286, 31C98733, 31C99989, 31E00821, 31E00853, 31E03707,
31E05023, 31E09243, 31E16576, 31E17330, 31E22416, 31E24282,
31E25172, 31E28746, 31E29578, 31E35043, 31E36969, 31E40086,
31E44819, 31E51957, 31E56507, 31E58705, 31E61365, 31E64117,
31E66182, 31E69776, 31E72786, 31E74498, 31E78280, 31E80171,
31E82789, 31E83019, 31E85450, 31E87921, 31E88847, 31E92205,
-4- 31E94519, 31F02595, 31F03328, 31F03920, 31F05195, 31F05744,
31F06529, 31F74946, 31F74947, 31F76711, 31F76854, 31F77316,
31F77466, 31F78263, 31F78481, 31F79010, 31F80586, 31F81625,
31F82225, 31F83000, 31F83614, 31F84515, 31F88640, 31F89273,
31F89922, 31F90588, 31F91275, 31F91960, 31F92571, 31F93222,
31F93980, 31F94657, 31F95335, 31F96139, 31F96862, 31F97494,
31F98239, 31F98831, 31F99486, 31G00215, 31G01182, 31G01284,
31G03604, 31G12518, 31G15194, 31G16220, 31G20921, 31G23614,
31G27569, 31G28814, 31G28826, 31G28833, 31G28841, 31GC16575,
31GC19394, 31GE07375, 31GE07869, 31GF10695, 31GF17093,
31GF17669, 31GF17677, 31H03167, 31H03270, 31H03919,
31H04308, 31H06253, 31H06298, 31H07622, 31H08364, 31H09185,
31H10149, 31H10578, 31H10583, 31H10618, 31H10625, 31H18987,
31H19032, 31H19875, 31H24083, 31H26519, 31H31844, 31H31848,
31H31863, 31H32928, 31H37882, 31H43823, 31H54311, 31H54375,
31H54390, 31H65984, 31H66681, 31H66714, 31H66726, 31H66843,
31H69422, 31H69432, 31H71160, 31H72620, 31H72649, 31H75458,
31H75475, 31H77008, 31H77020, 31H78352, 31H83922, 31H86338,
31H87782, 31H90843, 31H91046, 31H92780, 31H92785, 31H92789,
31H92796, 31H92817, 31H92824, 31H94100, 31H94119, 31H98665,
31H98737, 31J23765, 31J24931, 31J25131, 31J25207, 31J26153,
31J26400, 31J26481, 31J27216, 31J28569, 31J29037, 31J29796,
31J30104, 31J31066, 31J31179, 31J32324, 31J33442, 31J33837,
31J34520, 31J35379, 31J35779, 31J37023, 31J38511, 31J39122,
31J39874, 31J41845, 31J43125, 31J47314, 31J49497, 31J51981,
31J53736, 31J56743, 31J60167, 31K01054, 31K02649, 31K07638,
31K10391, 31K16426, 31K16488, 31K33813, 31K35254, 31K38699,
31K38711, 31K41248, 31K46625, 31K47311, 31K47513, 31K47520,
31K47538, 31K48983, 31K54799, 31K83942, 31K83947, 31K83948,
31K84142, 31K92522, 31K93243, 31K93756, 31K96794, 31K99533,
31K99535, 31K99677, 31L36223, 31L36224, 31L37427, 31L37436,
31L45082, 31L45553, 31L49108, 31L63003, 31L63815, 31L63827,
31L65055, 31L70884, 31L74993, 31L76662, 31L76670, 31L76680,
31L76685, 31L76697, 31L77577, 31M50064, 31M54392, 31M58505,
31M63279, 31M88028, 31N02127, 31N04611, 31N20442, 31N24221,
31N26153, 31N34244, 31N36002, 31N36952, 31R07311, 31R07574,
31R10856, 31R12296, 31R13302, 31R15262, 31R19974, 31R23871,
31R27133, 31R28189, 31R28202, 31R28214, 31R28223, 31R37623,
31R38759, 31R41081, 31R43855, 31R46715, 31R46717, 31R46743,
31R46755, 31R46774, 31R46898, 31R52922, 31R54527, 31R55362,
31R56022, 31R56509, 31R56516, 31R56517, 31R57643, 31R60838,
31R61318, 31R67403, 31R68649, 31R68719, 31R71813, 31R71865,
31R73662, 31R84271, 31R85106, 31R85156, 31R86501, 31R92347,
31R92766, 31R92778, 31R92779, 31R92787, 31R96018, 31R97517,
31R99490, 31R99516, 31R99519, 31R99818, 31S01427, 31S03396,
31S07240, 31S62935, 31S63622, 31S64456, 31S64461, 31S73501,
31S78540, 31S90134, 31S98725, 31T26119, 31T36539, 31T41069,
31T43069, 31V00939, 31V01635, 31V04669, 31V05289, 31V05792,
31V14485, 31W31503, 31W40613, 31W58539, 31W72356, 31X02796,
31X03864, 31X04228, 31X04602, 31X04782, 31X05170, 31X05536,
31X06089, 31X06145, 31X06616, 31X07186, 31X07738, 31X08397,
31X08551, 31X09031, 31X09266, 31Y00128, 31Y06087, 31Y07629,
-5- 31Y07948, 31Y10680, 31Y10681, 31Y16163, 31Y16218, 31Y19640,
31Y22953, 31Y25416, 31Y28071, 31Y35312, 31Y45573, 31Y47013,
31Y49864;
(c) 31C01437, 31C03496, 31C04715, 31C06778, 31C09120,
31C09937, 31C12338, 31C14941, 31C16108, 31C18513,
31C18830,31C20723, 31C21119, 31C22901, 31C23680, 31C25307,
31C26033, 31C30889, 31C33329, 31C35028, 31C52720, 31C56483,
31C60467, 31C66985, 31C68818, 31C69793, 31C73428, 31C75015,
31C76455, 31C76481, 31C81410, 31C83297, 31C84986, 31C87242,
31C89148, 31C91584, 31C92940, 31C96411, 31C96441, 31C98286,
31C98733, 31E00821, 31E05023, 31E24282, 31E25172, 31E28746,
31E35043, 31E36969, 31E40086, 31E44819, 31E56507, 31E58705,
31E61365, 31E69776, 31E74498, 31E83019, 31E85450, 31E87921,
31E88847, 31E92205, 31E94519, 31F02595, 31F03328, 31F03920,
31F05195, 31F05744, 31F06529, 31F76711, 31F76854, 31F77466,
31F79010, 31F80586, 31F81625, 31F82225, 31F83000, 31F83614,
31F84515, 31F88640, 31F89922, 31F90588, 31F91275, 31F91960,
31F93980, 31F96139, 31F98831, 31F99486, 31G12518, 31G20921,
31G27569, 31GC16575, 31GC19394, 31GE07375, 31GE07869,
31GF10695, 31GF17093, 31GF17652, 31H04308, 31H19032,
31H24083, 31H31844, 31H31848, 31H37882, 31H54311, 31H54375,
31H54390, 31H71160, 31H77008, 31H90843, 31J43125, 31J47314,
31J48475, 31J49497, 31J60167, 31K10391, 31K33813, 31K35254,
31K93243, 31L45553, 31L49108, 31L63003, 31L63815, 31L63827,
31L65055, 31L70884, 31L76670, 31L76680, 31L76685, 31L76697,
31L77577, 31M63279, 31M65382, 31M88028, 31N02127, 31N04611,
31N19228, 31N26153, 31N36002, 31R23871, 31R41081, 31R61318,
31R84271, 31R85106, 31R85156, 31R92766, 31R92779, 31R92787,
31R96018, 31S01427, 31S07240, 31S64461, 31S73501, 31S78540,
31S90134, 31S98725, 31T36539, 31T43069, 31V00939, 31V01635,
31V04669, 31W72356, 31X03864, 31X04782, 31X05170, 31X06145,
31X06616, 31X08397, 31X08551, 31X09031, 31X09266, 31Y07629,
31Y19640, 31Y45573;
(d) 31C01348, 31C05848, 31C09120, 31C09937, 31C11953,
31C12338, 31C17896, 31C20723, 31C22901, 31C25307, 31C50160,
31C53356, 31C57060, 31C58308, 31C64054, 31C65077, 31C70340,
31C71810, 31C82623, 31C86640, 31C90821, 31C94669, 31C95197,
31C96411, 31C96441, 31C98733, 31E29578, 31E51957, 31E56507,
31E61365, 31E64117, 31E72786, 31E80171, 31E83019, 31E87921,
31F03328, 31F03920, 31F05744, 31F06529, 31F75235, 31F75239,
31F77316, 31F78481, 31F84515, 31F92571, 31F93222, 31F94657,
31F97494, 31F98239, 31F99486, 31G15194, 31G23614, 31G27569,
31G28841, 31GC16575, 31GC19394, 31GE07375, 31GE07869,
31GF17669, 31H03167, 31H03919, 31H06253, 31H06298, 31H07622,
31H08364, 31H09185, 31H10578, 31H10618, 31H10625, 31H18987,
31H19875, 31H31844, 31H31848, 31H31863, 31H32928, 31H92817,
31H92824, 31J33442, 31J33837, 31J34520, 31J37023, 31J38511,
31J39122, 31J49497, 31J56743, 31K02649, 31K33813, 31K35254,
31K47513, 31K47520, 31K47538, 31K54799, 31K92522, 31K99533,
31K99535, 31L36223, 31L36224, 31L74993, 31L76670, 31L76680,
31L76685, 31L76697, 31M58505, 31M88028, 31N19228, 31N20442,
31N24221, 31N34244, 31N36002, 31R07311, 31R07574, 31R10856,
-6- 31R12296, 31R15262, 31R27133, 31R38759, 31R60838, 31R73662,
31R86501, 31R92347, 31R97517, 31R99490, 31R99516, 31R99519,
31S01427, 31S03396, 31S07240, 31S64456, 31T26119, 31V00939,
31V04669, 31V05792, 31W31503, 31W72356, 31X04228, 31X06089,
31X08397, 31Y10680, 31Y10681, 31Y25416, 31Y28071;
(e) 31C03496, 31C04715, 31C06778, 31C30889, 31C33329,
31C69793, 31C81410, 31C87242, 31C90773, 31C92940, 31E00821,
31E24282, 31E25172, 31E36969, 31E44819, 31E58705, 31E74498,
31E94519, 31F05195, 31F83000, 31F91960, 31F95335, 31G01182,
31GF17093, 31H03270, 31H24083, 31H54390, 31H77008, 31H83922,
31H98737, 31J26400, 31J30104, 31K01054, 31K10391, 31K48983,
31K96794, 31K99677, 31L45082, 31L63815, 31L63827, 31L70884,
31M63279, 31N04611, 31R67403, 31S62935, 31S73501, 31S78540,
31S90134, 31S98725, 31T43069, 31X06616, 31X07186, 31X07738,
31X08551, 31Y06087, 31Y49864;
(f) 31C16108, 31C25307, 31C33329, 31C62138, 31C90773,
31C96441, 31E00852, 31F75235, 31F75239, 31H66700, 31H66703,
31H66709, 31H66745, 31J24114, 31M65382, 31R38421, 31R38436,
31R38595, 31X03265;
(g) 31C01348, 31C78195, 31C88594, 31E22416, 31E66182,
31F89273, 31G16220, 31H26519, 31R10856, 31R12296, 31R92778,
31R92784, 31V14485, 31W40613, 31X07738;
(h) 31E03707, 31E09243, 31E35043, 31R86501, 31R97517,
31R99818, 31T41069, 31X02796, 31X03265, 31X04602, 31X08551,
31Y25416;
(i) 31C00215, 31C01348, 31C01437, 31C02593, 31C04682,
31C05582, 31C05848, 31C09120, 31C09937, 31C11953, 31C12338,
31C14941, 31C16108, 31C17896, 31C18513, 31C18830, 31C20723,
31C21119, 31C22901, 31C23680, 31C25307, 31C26033, 31C28749,
31C35028, 31C50111, 31C50123, 31C50147, 31C50160, 31C51901,
31C52720, 31C53356, 31C54698, 31C55238, 31C55442, 31C56483,
31C57060, 31C57564, 31C58308, 31C58582, 31C60467, 31C62138,
31C64054, 31C65077, 31C66985, 31C68818, 31C70340, 31C71462,
31C71810, 31C73428, 31C75015, 31C75022, 31C76455, 31C76481,
31C78195, 31C78593, 31C82623, 31C83297, 31C83935, 31C84986,
31C86640, 31C88594, 31C89148, 31C90821, 31C91584, 31C94669,
31C95197, 31C96411, 31C96441, 31C98286, 31C98733, 31C99989,
31E00852, 31E00853, 31E03707, 31E05023, 31E09243, 31E16576,
31E17330, 31E21270, 31E22416, 31E28746, 31E29578, 31E35043,
31E40086, 31E51957, 31E56507, 31E61365, 31E64117, 31E66182,
31E69776, 31E72786, 31E78280, 31E80171, 31E83019, 31E85450,
31E87921, 31E88847, 31E92205, 31E96900, 31F02595, 31F03328,
31F03920, 31F05744, 31F06529, 31F74946, 31F74947, 31F75235,
31F75239, 31F76711, 31F76854, 31F77316, 31F77466, 31F78263,
31F78481, 31F79010, 31F80586, 31F81625, 31F82225, 31F83614,
31F84515, 31F85256, 31F85986, 31F86700, 31F87382, 31F88018,
31F88640, 31F89273, 31F89922, 31F90588, 31F92571, 31F93222,
31F93980, 31F94657, 31F96139, 31F96862, 31F97494, 31F98239,
31F98831, 31F99486, 31G00215, 31G01284, 31G03604, 31G12518,
31G15194, 31G16220, 31G20921, 31G23614, 31G27569, 31G28814,
31G28826, 31G28833, 31G28841, 31GC16575, 31GC19394,
31GE07375, 31GE07869, 31GF10695, 31GF17669, 31H03167,
-7- 31H03919, 31H06253, 31H06298, 31H07622, 31H08364, 31H09185,
31H10149, 31H10578, 31H10618, 31H10625, 31H18987, 31H19032,
31H19875, 31H26519, 31H31844, 31H31848, 31H31863, 31H32928,
31H37882, 31H43823, 31H54311, 31H54375, 31H65984, 31H66681,
31H66700, 31H66703, 31H66709, 31H66714, 31H66726, 31H66745,
31H66843, 31H69422, 31H69432, 31H71160, 31H72620, 31H72649,
31H75458, 31H75475, 31H77020, 31H78352, 31H86338, 31H87782,
31H90843, 31H91046, 31H92780, 31H92785, 31H92789, 31H92796,
31H92817, 31H92824, 31H94100, 31H94119, 31H98665, 31J23765,
31J24114, 31J24931, 31J25131, 31J25207, 31J26153, 31J26481,
31J27216, 31J28569, 31J29037, 31J29796, 31J31066, 31J31179,
31J32324, 31J33442, 31J33837, 31J34520, 31J35379, 31J35779,
31J37023, 31J38511, 31J39122, 31J39874, 31J41845, 31J43125,
31J47314, 31J48475, 31J49497, 31J51981, 31J53736, 31J56743,
31J60167, 31K02649, 31K07638, 31K16426, 31K16488, 31K18242,
31K33813, 31K35254, 31K38699, 31K38711, 31K41248, 31K46625,
31K47311, 31K47513, 31K47520, 31K47538, 31K54799, 31K83942,
31K83947, 31K83948, 31K84142, 31K92522, 31K93243, 31K93756,
31K99533, 31K99535, 31L35404, 31L36223, 31L36224, 31L37427,
31L37436, 31L45553, 31L49108, 31L63003, 31L65055, 31L74993,
31L76662, 31L76670, 31L76680, 31L76685, 31L76697, 31L77577,
31M50064, 31M54392, 31M58505, 31M65382, 31M88028, 31N02127,
31N19228, 31N20442, 31N24221, 31N25025, 31N26153, 31N34244,
31N36002, 31N36952, 31R07311, 31R07574, 31R10856, 31R12296,
31R13302, 31R15262, 31R19974, 31R23871, 31R27133, 31R28189,
31R28202, 31R28214, 31R28223, 31R37623, 31R38421, 31R38436,
31R38595, 31R38759, 31R41081, 31R43855, 31R46715, 31R46717,
31R46743, 31R46755, 31R46774, 31R46898, 31R52922, 31R54527,
31R55362, 31R56022, 31R56509, 31R56516, 31R56517, 31R57643,
31R60838, 31R61318, 31R68649, 31R68719, 31R71813, 31R71865,
31R73662, 31R84271, 31R85106, 31R85156, 31R86501, 31R92347,
31R92766, 31R92778, 31R92779, 31R92784, 31R92787, 31R96018,
31R97517, 31R99490, 31R99516, 31R99519, 31R99818, 31S01427,
31S03396, 31S07240, 31S63622, 31S64456, 31S64461, 31T26119,
31T36539, 31T41069, 31V00939, 31V01635, 31V04669, 31V05289,
31V05792, 31V14485, 31W31503, 31W40613, 31W47299, 31W58539,
31W72356, 31X02796, 31X03265, 31X03864, 31X04228, 31X04602,
31X04782, 31X05170, 31X05536, 31X06089, 31X06145, 31X08397,
31X09031, 31X09266, 31Y00128, 31Y07629, 31Y07948, 31Y10680,
31Y10681, 31Y16163, 31Y16218, 31Y16314, 31Y19640, 31Y22953,
31Y25416, 31Y28071, 31Y35312, 31Y45573, 31Y47013.
MANUFACTURER American Red Cross Blood Services, Buffalo, New York.
RECALLED BY Manufacturer, by telephone November 1992, and by letters
dated between April 20, 1993, and June 8, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Switzerland.
QUANTITY (a) 2 units; (b) 424 units; (c) 172 units; (d) 141 units;
(e) 56 units; (f) 19 units; (g) 15 units; (h) 12 units;
(i) 404 units.
-8- REASON Blood products, which either: 1) tested repeatedly reactive
for the antibody to the human immunodeficiency virus type 1
(anti-HI-1); or 2) tested negative for anti-HI-1, but were
collected from donors who previously tested repeatedly
reactive for anti-HI-1, were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-372-3.
CODE Unit #FOH9713.
MANUFACTURER Fairfax Hospital System, Inc., doing business as Fair Oaks
Hospital, Fairfax, Virginia.
RECALLED BY Manufacturer, by telephone July 9, 1993, and by letter dated
July 13, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Maryland.
QUANTITY 1 unit.
REASON Blood product which tested initially reactive for Hepatitis
B surface Antigen was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma; (c) Recovered
Plasma; (d) Red Blood Cells for further manufacture; (e)
Platelets for further manufacture. Recall #B-373/377-3.
CODE Unit numbers: (a) Q5913; (b) M20889/2; (c) Q5913/2;
(d) H30052 and H31324; (e) H31324/1.
MANUFACTURER Milton S. Hershey Medical Center University Hospital Blood
Bank, Hershey, Pennsylvania.
RECALLED BY Manufacturer, by telephone May 26 and 27, 1993, followed by
letter May 28, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, New Jersey, Maryland.
QUANTITY (a) 1 unit; (b) 1 unit; (c) 1 unit; (d) 2 units; (e) 1 unit.
REASON Blood products, which tested negative for the antibody to
the Human Immunodeficiency Virus type I (anti-HIV-1) but
were collected from a donor who previously tested reactive
for anti-HIV-1, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
===================
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-370/371-3.
CODE Unit #31H66467.
MANUFACTURER American Red Cross Blood Services, Buffalo, New York.
RECALLED BY Manufacturer, by letters dated between April 20, 1993, and
June 8, 1993. Firm-initiated recall ongoing.
DISTRIBUTION (a) New York, (b) California, Switzerland, The Netherlands.
QUANTITY 1 unit of each component.
REASON Blood products, which tested repeatedly reactive for anti-
HIV-1, were distributed.
-9- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
======================
_______________
PRODUCT Mevatron Linear Accelerators, Digital Controlled for x-ray
and electron beam therapy. Recall #Z-647-3.
CODE Serial numbers: 1918, 1996, 2005, 2038, 2055, 2095, 2127,
2229, 2231, 2233, 2234, 2235, 2239, 2241, 2242, 2244, 2245,
2249, 2252, 2258.
MANUFACTURER Siemens Medical Laboratories, Inc., Concord, California.
RECALLED BY Manufacturer, by replacing/upgrading the software to version
3.5 to correct the apparent loss of patient data. Firm-
initiated field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 20 units were distributed.
REASON Products were distributed without adequate software
verification.
_______________
PRODUCT Quantum 2000 Ultrasound System, Software version 1.32. The
system projects ultrasound energy from a transducer in
direct contact with the body for the purpose of detecting
abnormalities in soft tissue structures and vessels.
Recall #Z-649-3.
CODE All Quantum 2000 systems with software version 1.32. The
serial numbers fall within an approximate range of 1000-
1300.
MANUFACTURER Siemens Medical Systems, Inc., Issaquah, Washington.
RECALLED BY Manufacturer, by visit between May 25, 1992 and January 13,
1993. Firm-initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 150 systems with software version 1.32 that received the
1.33 software version upgrade.
REASON The grey scale image quality fails to meet product
requirements.
_______________
PRODUCT Quantum 2000 Ultrasound System, with software version 1.32
and 1.33. The system projects ultrasound energy from a
transducer in direct contact with the body for the purpose
of detecting abnormalities in soft tissue structures and
vessels. Recall #Z-650-3.
CODE All Quantum 2000 ultrasound systems with software version
1.32 and 1.33 are scheduled to receive the 1.34 software
upgrade (serial numbers 1000-1402).
MANUFACTURER Siemens Medical Systems, Inc., Ultrasound Group, Issaquah,
Washington.
RECALLED BY Manufacturer, by field correction. As of 4/26/93,
approximately 71 systems have been upgraded.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 400 systems were distributed.
REASON The software allows the transducer to exceed its 150 degree
F specification.
-10- _______________
PRODUCT Endoscopic Light Sources: (a) Model CLK-4 Endoscopic Light
Source; (b) Model CLV-U20 Endoscopic Light Source.
Recall #Z-661/662-3.
CODE Serial numbers: (a) 8216999-8217007, 8217016-8217042,
8217044, 8217045, 8217047-8217079, 8217081-8217086; (b)
8254963-8255011, 8255013, 8255015-8255020, 8255022-8255029,
8255031-8255033, 8355035-8355052, 8355057, 8355059-8355061,
8355063, 8355065-8355068, 8355071, 8355073-8355076, 8355080.
MANUFACTURER Olympus Corporation, Rio Rancho, New Mexico.
RECALLED BY Olympus Corporation, Lake Success, New York, by letter March
2, 1993. Firm-initiated recall ongoing.
DISTRIBUTION (a) Nationwide, (b) Tennessee, Wisconsin, Illinois.
QUANTITY (a) 42 units; (b) 3 units were distributed.
REASON The light sources Models CLK-4 and CLV-420 did not receive
the Quality Assurance (QA) high voltage surge test required
under Olympus Corporation Standard Operating Procedure. The
devices may not be able to safely sustain a power surge.
_______________
PRODUCT Trimedyne Taper Tip 20 and 30 degree Laser Catheter.
Recall #Z-666/667-3.
CODE Lot numbers 7745, 7840, 7453, 7703.
MANUFACTURER Trimedyne, Inc., Irvine, California.
RECALLED BY Manufacturer by May 21, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, international.
QUANTITY 455 units were distributed.
REASON Unanticipated breakage of the laser fiber near the handle of
the catheter.
_______________
PRODUCT Fisher & Paykel Mounting Clamp, C-Clamp (19-40 mm), Catalog
#900MR085, for use with Fisher & Paykel Respiratory and
Anesthesia Humidifier heater Bases, Catalog numbers MR410,
MR480, MR700, MR720, MR730, the clam mounts heater base to
an I.V. pole for increased mobility. Recall #Z-701-3.
CODE All lots.
MANUFACTURER Fisher & Paykel Electronics, Ltd., Aukland, New Zealand.
RECALLED BY Baxter Healthcare Corporation, Round Lake, Illinois, by
letter January 29, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,348 units were distributed.
REASON The device could possibly break. If this occurs water may
be introduced into ventilator tubing, or tubing may become
disengaged from the ventilator, humidifier or patient.
-11-
_______________
PRODUCT MV Aerochamber, single-patient use Rx device, nebulizer used
to deliver liquid aerosol medication to a mechanically
ventilated (MV) patient: (a) 15 mm case of 10 part #82510;
(b) 15 mm case of 50, part #82550; (c) 22 mm case of 10,
part #87510. Recall #Z-703/705-3.
CODE All lots manufactured from July 1991 to November 1992.
MANUFACTURER Monaghan Medical Corporation, Plttsburgh, New York.
RECALLED BY Manufacturer, by telephone January 21, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 972 cases; (b) 955 cases; (c) 339 cases were
distributed.
REASON Device could possibly become disengaged while being placed
in or being removed from the patient circuit, which could
allow medication to leak from the unit.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
=====================
_______________
PRODUCT Entrac Urotrieve Stone Retrievers, used for the endoscopic
removal of renal and ureteral stones: (a) Stone Retrievers:
(b) Ureteral Stent-Firm; (c) Soft Stent.
Recall #Z-686/699-3.
CODE Product No. Lot No.
(a) 48010644 78254
48010944 78269
48020623 78242, 78243
48020644 78255
48020923 78244, 78246, 78247, 78249, 78250, 78251,
78288, 78289
48020944 78268, 78290
48030644 78256, 78257, 78259, 78260, 78261, 78263,
78291, 78292
48030944 78274, 78279, 78280, 78295,
48030956 78282;
(b) 40011624 78060
40011626 78082
40011628 78063
40011724 78064, 78089,
40011726 78065, 78092, 78093
40011728 78066
-12- (c) 40034624 77276
40034626 78217, 78218,
40034724 67408
40034726 74925, 75114.
MANUFACTURER Angiomed Aktiengesellschaft, Germany.
RECALLED BY American Medical Systems, Inc., Minnetonka, Minnesota, by
letter June 7, 1993. Firm-initiated recall complete.
DISTRIBUTION Alabama, California, Colorado, Connecticut, Florida,
Georgia, Indiana, Massachusetts, Michigan, New Jersey, North
Carolina, Ohio.
QUANTITY 936 units were distributed.
REASON Mislabeling. After the products were shipped from the
foreign manufacturer to the recalling firm, procedures were
supposed to provide for the addition of "Instructions for
Use" to each individually packaged device. The instructions
for Use were not added to the devices which were first
marketed by the recalling firm on 5/17/93 before the problem
was discovered on 5/28/93.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________
PRODUCT IMx System Reaction Cells, for use only with MEIA Reagents,
List #8397-03, a self-contained, chambered reaction cell
allowing for automated pretreatment or dilution when
required. Recall #Z-702-3.
CODE Lot #73657Q100, 73658Q100, 73659Q100, 73663Q100.
MANUFACTURER Abbott Laboratories, Diagnostics Division, Barceloneta,
Puerto Rico.
RECALLED BY Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois, by letter May 6, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 25,551 cartons (100 cells per carton) were distributed.
REASON Defective cells may cause pooling on matrix.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Tetracyline HCl (250 mg capsules, labeled for human use as
Blue Tetracycline HCL Capsules. An additional label
attached "For Aquarium Use Only. Recall #V-041-3.
CODE Lot #2A02 EXP 2/96, Catalog #J352.
MANUFACTURER Jungle Laboratories Corporation, Cibolo, Texas.
RECALLED BY Manufacturer, by telephone July 22, 1993, followed by letter
August 2, 1993. Firm-initiated recall ongoing.
DISTRIBUTION California, Florida, Georgia, Louisiana, Massachusetts,
Michigan, Ohio, Tennessee.
QUANTITY 74 100-capsule bottles were distributed.
REASON Product is an unapproved new animal drug.
-13-
CRIMINAL INDICTMENT:
======================================================
AGAINST Baldev Raj Bhutani, Neelam Bhutani, and Alra
Laboratories, Inc., Gurnee, Illinois.
CHARGES In a five-count Indictment, the defendants were
charged with having caused, with intent to defraud
and mislead, a label to be affixed to Lactulose
Syrup USP, which was false and misleading. The
defendants were also charged with having
caused the adulteration, with intent to defraud and
mislead, of Lactulose Syrup USP, in that: the
product consisted in part of a decomposed substance;
the product had not been manufactured in accordance
with Good Manufacturing Practices; and, the
manufacturing procedures for this drug product had
been materially altered by adding an undocumented
substance, Sodium Hydroxide, more than two years
after the original manufacture. The defendants,
with intent to defraud and mislead, failed to
establish and maintain accurate manufacturing batch
production records for the Lactulose Syrup, in that
they materially altered the manufacturing procedures for
his product by causing Sodium Hydroxide to be added to this
product more than two years after its original manufacture
but, in order to conceal this unauthorized procedure from
the FDA, failed to document this unapproved manufacturing
procedure in the production batch records. The defendants
were charged with having caused, with intent to defraud and
mislead, the introduction into interstate commerce for
delivery, of Lactulose Syrup which was misbranded.
The defendants were also charged with having caused,
with intent to defraud and mislead, the introduction
into interstate commerce for delivery, of
Lactulose Syrup USP, which was adulterated.
FILED August 11, 1993; U.S. District Court for the
Northern District of Illinois, Eastern Division; Cr.
#93CR0585; FDC #66103.
-14-
####