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
08/18/1993
Recalls and Field Corrections: Drugs -- Class II -- 08/18/1993
AUGUST 18, 1993
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
========================
_______________
PRODUCT Diazepam, Tablets, 2 mg, in bottles of 100, used for anxiety
disorders. Recall #D-318-3.
CODE Lot numbers: 1532-040, 1532-041.
MANUFACTURER Lederle Laboratories, Inc., Pearl River, New York.
RECALLED BY Vanguard Labs, Inc., Glasgow, Kentucky (repacker), by letter
July 30, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 535 boxes were distributed.
REASON A bottle received from the manufacturer labeled as
containing 2 mg tablets contained 5 mg tablets.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
=======================
_______________
PRODUCT Acetaminophen with Codeine Tablets, 300 mg, in 100 tablet
unit dose cartons, 5 sheets of 20 unit dose blister packs,
and 10 sheets of 10 unit dose blister packs, Rx drug for the
relief of mild to moderately severe pain. Recall #D-313-3.
CODE Lot numbers 2F768, 2F747.
MANUFACTURER Barr Laboratories, Inc., Northvale, New Jersey.
RECALLED BY UDL Laboratories, Inc., Rockford, Illinois (repacker), by
telephone July 9-28, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 347 unit cartons were distributed; firm estimates 28 cartons
remain on the market.
REASON Potency of codeine ingredient not assured through expiration
date.
_______________
PRODUCT Sulfisoxazole 500 mg/Phenazopyridine HCl 50 mg labeled as
Azo-Gulfasin, Major label; Suflfisoxole and Phenazopyridine
HCl 500 mg/50 mg, Trinity label; Azo-Sulfisoxazole,
Qualitest label, in bottles of 100 and 1,000, for initial
treatment of uncomplicated urinary tract infections.
Recall #D-314-3.
CODE Lot numbers: C119D, C120D, D121D, D111D, D110D, D124D.
MANUFACTURER Manufacturing Chemists, Inc., Indianapolis, Indiana.
RECALLED BY Trinity Technologies Corporation, Roseville, Michigan, by
letter July 27, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Alabama.
QUANTITY 60 100-tablet bottles, Lot C119D, (Major label);
1,307 100-tablet bottles, Lot C119D, (Trinity label);
1,097 100-tablet bottles, Lot C120D, (Trinity label);
68 1,000-tablet bottles, Lot D111D, (Major label);
1,247 100-tablet bottles, Lot D110D, (Trinity label);
2,437 100-tablet bottles, Lot C124D, (Qualitest label)
were distributed.
REASON Product marketed without new drug approval.
_______________
PRODUCT Conex D.A., decongestant/antihistaminic, in bottles of 100
and 1,000, for temporary relief of symptoms associated with
nasal allergies, sinusitis and rhinitis. Recall #D-315-3.
CODE Lot 10901 EXP 11/93.
MANUFACTURER Forest Pharmaceuticals, Inc., Cincinnati, Ohio.
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis, Missouri, by
telephone April 30, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,147 100-tablet bottles and 230 1,000-tablet bottles were
distributed.
REASON Subpotency of the phenylpropanolamine ingredient.
_______________
PRODUCT Queltuss Antitussive-Expectorant, packaged in 1,000-tablet
bottles, a non-narcotic cough suppressant. Recall #D-316-3.
CODE Lot #1912 EXP 3/94.
MANUFACTURER Forest Pharmaceuticals, Inc., Cincinnati, Ohio.
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis, Missouri, by
telephone April 30, 1993. Firm-initiated recall complete.
DISTRIBUTION California, Indiana, Wisconsin, Ohio, Minnesota, Colorado,
Kentucky, Iowa, New York, Illinois, Canada.
QUANTITY 186 bottles were distributed.
REASON Subpotency of the dextromethorphan ingredient.
-2- _______________
PRODUCT Conex Plus Tablets, antihistaminic/analgesic/decongestant,
in bottles of 1,000, for the temporary symptomatic relief of
nasal congestion, mild pain, and fever. Recall #D-317-3.
CODE Lot #29129 EXP 4/94.
MANUFACTURER Forest Pharmaceuticals, Inc., Cincinnati, Ohio.
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis, Missouri, by
telephone April 30, 1993. Firm-initiated recall complete.
DISTRIBUTION Indiana, Pennsylvania, Kentucky, Maine, Tennessee, Iowa,
Illinois, New Jersey, Alabama, Arizona, Michigan, Ohio,
Missouri.
QUANTITY 234 bottles were distributed.
REASON Subpotency of the phenylpropanolamine ingredient.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
====================
_______________
PRODUCTS: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Platelets for Further Manufacture; (e) Recovered Plasma.
Recall #B-310/314-3.
CODE Unit numbers: (a) H00093-1, H00117-7, H00154-6, H00275-2,
H00293-6, H00334-3, H00438-8, H00525-6, H00592-6, H00798-1,
H00878-1, H00923-1, H00958-1, H01001-X, H01014-9, H01185-3,
H01210-6, H01278-2, H01335-X, H01582-7, H01658-4, H01753-2,
H01847-3, H01856-5, H01929-7, H01932-8, H02074-5, H02089-8,
H02160-1, H02294-7, H02321-3, H02411-7, H02449-2, H02610-X,
H02615-9, H02690-9, H02769-1, H02941-4, H02990-0, H03042-5,
H03072-6, H03088-0, H03107-7, H03119-4, H03181-5, H03196-8,
H03289-7, H03304-6, H03336-0, H03383-3, H03409-2, H03425-2,
H03564-2, H03594-3, H03616-5, H03803-0, H03848-3, H03880-4,
H03893-3, H03935-2, H03955-X, H03976-9, H03982-5, H04040-6,
H04053-5, H04164-2, H04259-0, H04350-1, H04387-5, H04393-1,
H04396-7, H04406-1, H04421-X, H04597-3, H04599-7, H0466-4,
H04871-7, H04879-1, H04886-X, H04931-0, H05026-4, H05064-5,
H05072-5, H05141-X, H05302-6, H05358-0, H05377-6, H05430-6,
H05470-0, H05489-0, H05545-6, H05568-9, H05665-0, H05711-2,
H05742-5, H05787-9, H05800-4, H05893-2, H05924-6, H06050-9,
H06231-8, H06259-X, H06343-2, H06429-3, H06477-8, H06479-1,
H06598-4, H06650-2, H06775-6, H06789-7, H06897-4, H06920-3,
H06948-5, H06962-1, H07118-0, H07133-9, H07197-8, H07248-9,
H07291-4, H07309-3, H07402-8, H07472-3, H07528-3, H07556-0,
H07660-0, H07670-4, H07758-9, H07915-3, H08021-9, H08041-6,
H08166-X, H08326-X, H08333-8, H08356-0, H08369-X, H50360-4,
H51761-0, H51776-X, H51920-9, H51979-3, H52141-4, H52186-8,
H52200-5, H52204-2, H52311-8, H52324-7, H52454-5, H52522-8,
H52589-2, H52660-6, H52739-9, H53019-5, H53045-9, H53048-4,
H53052-7, H53057-6, H53091-X, H53141-9, H53322-8, H53335-7,
H53354-2, H53467-9, H53468-C, H53482-7, H53547-9, H53603-4,
H53726-4, H53794-6, H53900-0, H53904-8, H53990-3, P02991-6,
P03680-3, P03690-7, P03694-4, P03695-6, P03697-X, P03709-8,
P03987-8, P04064-4, P04430-5, P04665-X, P04784-2, P05227-4,
P05321-0, P05467-3, P05546-1, P05690-6, P05942-3, P06125-8,
-3- P06197-7, P06260-0, P06496-7, P06537-4, P06543-0, P07407-0,
P07450-6, P07539-2, P07558-8, P07937-8, P08019-3, P08103-6,
P08172-X, P08229-1, P08605-6, P08750-2, P08798-1, P08852-3,
P08862-7, P08971-6, P09233-9, P09234-0, P09385-8, P09477-5,
P09486-7, P09525-0, P09748-8, P09853-X, P09860-8, P09883-0,
P10290-3, P10302-1, P10708-1, P10715-X, P10716-1, P10729-0,
P10730-8, P10731-X, P10732-1, P10733-3, P10734-5, P10735-7,
P10737-0, P10742-5, P10889-X, P10928-3, P10989-7, P11114-9,
P11117-4, P11162-3, P11169-6, P11228-7, P11231-8, P11260-7,
P11270-0, P11272-4, P11318-0, P11487-1, P11499-9, P11528-9,
P11549-8, P11551-7, P11552-9, P11554-2, P11556-6, P11564-6,
P11572-6, P11677-2, P11685-2, P11823-1, P11859-3, P11870-4,
P12019-5, P12033-1, P12067-X, P12071-2, P12157-3, P12265-0,
P12327-7, P12333-3, P12372-6, P12434-2, P12444-6, P12497-X,
P12501-3, P12667-3, P12704-3, P12728-8, P12853-7, P12870-9,
P13033-6, P13084-6, P13164-6, P13235-4, P13245-8, P13284-0,
P13313-0, P13342-X, P13501-8, P13582-9, P13605-2, P13625-X,
P13670-9, P13813-7, P13820-5, P13881-9, P13886-8, P13937-9,
P13944-7, P14122-2, P14194-1, P14198-9, P14279-0, P14796-9,
P15053-2, P15059-3, P15067-3, P15079-0, P15128-8, P15181-7,
P15197-1, P15262-9, P15324-5, P15374-3, P15431-0, P15457-5,
P15529-9, P15583-X, P15599-4, P15663-X, P15740-4, P15777-8,
P15788-3, P15829-0, P15876-3, P15908-9, P15924-9, P16055-0,
P16267-2, P16292-4, P16520-7, P16705-3, P16710-8, P16733-0,
P16780-3, P16881-2, P16894-1, P16989-4, P17028-X, P17030-9,
P17077-6, P17227-2, P17229-6, P17258-5, P17294-2, P17392-6,
P17430-8, P17446-2, P17593-9, P17780-9, P17821-5, P17854-1,
P17892-2, P17902-7, P17955-0, P18112-7, P18147-7, P18147-7,
P18169-8, P18193-8, P18205-6, P18261-0, P18264-6, P18353-8,
P18375-9, P18507-1, P18510-2, P18520-6, P18540-3, P18558-1,
P18594-9, P18893-9, P18916-2, P18940-2, P18964-7, P18969-6,
P18976-4, P19031-X, P19253-5, P19269-X, P19309-5, P19380-8,
P19392-5, P19457-7, P19492-2, P19753-1, P19840-X, P19855-2,
P19858-6, P19858-8;
(b) H00093-1, H00438-8, H00525-6, H00592-6, H00878-1,
H01185-3, H01210-6, H01278-2, H01335-X, H02074-5, H02089-8,
H02160-1, H02321-3, H02411-7, H03848-3, H04387-5, H04393-1,
H04396-7, H04597-3, H04599-7, H0466-4, H04871-7, H04879-1,
H04886-X, H04931-0, H05026-4, H05064-5, H05072-5, H05302-6,
H05430-6, H05489-0, H05545-6, H05568-9, H05665-0, H05742-5,
H05800-4, H06050-9, H06231-8, H06259-X, H06343-2, H06479-1,
H06598-4, H06650-2, H06775-6, H06789-7, H06920-3, H06948-5,
H07118-0, H07133-9, H07197-8, H07402-8, H07528-3, H07556-0,
H07660-0, H07670-4, H07753-X, H07758-9, H08166-X, H51761-0,
H51776-X, H51920-9, H52186-8, H52200-5, H52204-2, H52311-8,
H52454-5, H52589-2, H52660-6, H53019-5, H53091-X, H53141-9,
H53335-7, H53354-2, H53467-9, H53468-C, H53482-7, H53547-9,
H53603-4, H53726-4, H53900-0, H53904-8, H53990-3, P01636-7,
P04665-X, P05227-4, P05467-3, P05546-1, P05942-3, P06125-8,
P06197-7, P06543-0, P07407-0, P07450-6, P07539-2, P07558-8,
P07937-8, P08019-3, P08103-6, P08172-X, P08229-1, P08605-6,
-4- P08750-2, P08798-1, P08852-3, P08862-7, P08971-6, P09233-9,
P09234-0, P09385-8, P09477-5, P09486-7, P09525-0, P09748-8,
P09853-X, P09860-8, P09883-0, P10290-3, P10302-1, P10729-0,
P10730-8, P10731-X, P10732-1, P10733-3, P10735-7, P10737-0,
P10742-5, P10889-X, P10928-3, P10989-7, P11162-3, P11228-7,
P11231-8, P11270-0, P11272-4, P11551-7, P11556-6, P11677-2,
P11685-2, P11823-1, P11859-3, P11870-4, P12019-5, P12033-1,
P12067-X, P12071-2, P12265-0, P12327-7, P12333-3, P12372-6,
P12434-2, P12501-3, P12577-X, P12728-8, P12853-7, P13033-6,
P13235-4, P13284-0, P13313-0, P13342-X, P13582-9, P13605-2,
P13625-X, P13670-9, P13813-7, P13820-5, P13881-9, P13886-8,
P13944-7, P14194-1, P14198-9, P14279-0, P15059-3, P15067-3,
P15079-0, P15197-1, P15262-9, P15324-5, P15374-3, P15583-X,
P15876-3, P17392-6, P17430-8, P17446-2, P17583-9, P17892-2,
P17902-7, P18112-7, P18205-6, P18261-0, P18264-6, P18353-8,
P18375-9, P18520-6, P18540-3, P18558-1, P18594-9, P18893-9,
P18916-2, P18940-2, P18964-7, P18976-4, P19031-X, P19380-8,
P19457-7, P19492-2;
(c) H00093-1, H00117-7, H00154-6, H00334-3, H00525-6,
H01185-3, H01278-2, H01335-X, H01392-6, H01582-7, H01847-3,
H01856-5, H01929-7, H02074-5, H02294-7, H02449-2, H02610-X,
H51979-3, H52141-4, H52200-5, H52311-8, H52324-7, H52454-5,
H52739-9, H53057-6, H53354-2, H53794-6, H53990-3, P02991-6,
P03680-3, P03690-7, P03691-9, P03694-4, P03695-6, P03697-X,
P03709-8, P03987-8, P04064-4, P04430-5, P04784-2, P05227-4,
P05467-3, P05690-6, P06260-0, P06496-7, P07450-6, P07558-8,
P07937-8, P08019-3, P09385-8, P09853-X, P09883-0, P10290-3,
P10302-1, P10708-1, P10715-X, P10716-1, P10729-0, P10733-3,
P10737-0, P10889-X, P11169-6, P11318-0, P11823-1, P12067-X,
P12444-6, P12501-3, P13084-6, P13342-X, P13670-9, P13813-7,
P14122-2, P14194-1, P14198-9, P14796-9, P17028-X;
(d) H00275-2, H00293-6, H00334-3, H00923-1, H00958-1,
H01001-X, H01014-9, H01753-2, H01856-5, H01929-7, H01932-8,
H03042-5, H03072-6, H03088-0, H03107-7, H03119-4, H03181-5,
H03196-8, H03409-2, H03425-2, H03564-2, H03803-0, H04040-6,
H04406-1, H04421-X, H05141-X, H05711-2, H05787-9, H05924-6,
H07248-9, H07291-4, H07309-3, H07472-3, H07907-3, H07915-3,
H08010-3, H08021-9, H08041-6, H52739-9, H53794-6, P06537-4,
P12667-3, P12704-3, P12870-9, P13937-9, P14122-2, P15128-8,
P15181-7, P15529-9, P15740-4, P15829-0, P15908-9, P15924-9,
P16780-3, P16881-2, P17854-1, P18147-7, P18169-8, P19253-5,
P19269-X, P19309-5, P19392-5;
(e) H00275-2, H00293-6, H00438-8, H00592-6, H00878-1,
H00923-1, H00958-1, H01001-X, H01014-9, H01210-6, H01421-6,
H01435-7, H01658-4, H01932-8, H02089-8, H02160-1, H02321-3,
H02411-7, H02615-9, H02690-9, H02769-1, H02941-4, H02990-0,
H03042-5, H03072-6, H03088-0, H03107-7, H03119-4, H03181-5,
H03196-8, H03289-7, H03336-0, H03383-3, H03409-2, H03425-2,
H03564-2, H03594-3, H03616-5, H03803-0, H03848-3, H03880-4,
H03893-3, H03935-2, H03976-9, H03982-5, H04040-6, H04053-5,
H04161-2, H04259-0, H04350-1, H04387-5, H04393-1, H04396-7,
H04406-1, H04421-X, H04597-3, H04599-7, H0466-4, H04871-7,
H04879-1, H04886-X, H04931-0, H05026-4, H05072-5, H05141-X,
-5- H05302-6, H05358-0, H05377-6, H05430-6, H05489-0, H05545-6,
H05568-9, H05665-0, H05742-5, H05787-9, H05800-4, H05893-2,
H05924-6, H06050-9, H06231-8, H06259-X, H06343-2, H06429-3,
H06479-1, H06598-4, H06650-2, H06775-6, H06789-7, H06897-4,
H06948-5, H06962-1, H07118-0, H07133-9, H07197-8, H07248-9,
H07291-4, H07309-3, H07402-8, H07472-3, H07528-3, H07556-0,
H07660-0, H07670-4, H07753-X, H07758-9, H07915-3, H08021-9,
H08041-6, H08166-X, H08326-X, H08333-8, H08355-9, H08356-0,
H50360-4, H51761-0, H51776-X, H51920-9, H52204-2, H52522-8,
H52589-2, H52660-6, H53019-5, H53045-9, H53048-4, H53052-7,
H53091-X, H53141-9, H53335-7, H53467-9, H53482-7, H53547-9,
H53603-4, H53726-4, H53900-0, H53904-8, P04665-X, P06125-8,
P06197-7, P06537-4, P06543-0, P07407-0, P07539-2, P08103-6,
P08172-X, P08229-1, P08605-6, P08798-1, P08852-3, P08862-7,
P08971-6, P09233-9, P09234-0, P09477-5, P09486-7, P09525-0,
P09748-8, P09860-8, P10730-8, P10731-X, P10732-1, P10735-7,
P10742-5, P10928-3, P10989-7, P11114-9, P11117-4, P11162-3,
P11228-7, P11231-8, P11270-0, P11272-4, P11499-9, P11528-9,
P11549-8, P11551-7, P11552-9, P11556-6, P11564-6, P11572-6,
P11677-2, P11685-2, P11859-3, P11870-4, P12019-5, P12033-1,
P12071-2, P12327-7, P12333-3, P12372-6, P12434-2, P12577-X,
P12667-3, P12728-8, P12853-7, P12870-9, P13033-6, P13245-8,
P13284-0, P13313-0, P13501-8, P13582-9, P13605-2, P13625-X,
P13670-9, P13820-5, P13881-9, P13886-8, P13937-9, P13944-7,
P14279-0, P14742-3, P14796-9, P15059-3, P15067-3, P15079-0,
P15128-8, P15181-7, P15197-1, P15262-9, P15324-5, P15374-3,
P15529-9, P15583-X, P15599-4, P15740-4, P15745-3, P15777-8,
P15788-3, P15829-0, P15876-3, P15908-9, P15924-9, P15957-5,
P16267-2, P16292-4, P16520-7, P16577-8, P16705-3, P16733-0,
P16780-3, P16881-2, P16894-1, P16970-4, P16989-4, P17030-9,
P17077-6, P17227-2, P17229-6, P17258-5, P17294-2, P17392-6,
P17430-8, P17446-2, P17583-9, P17780-9, P17854-1, P17892-2,
P17902-7, P17955-0, P18169-8, P18193-8, P18205-6, P18261-0,
P18264-6, P18353-8, P18375-9, P18507-1, P18510-2, P18520-6,
P18540-3, P18558-1, P18594-9, P18916-2, P18940-2, P18964-7,
P18969-6, P18976-4, P19031-X, P19253-5, P19269-X, P19309-5,
P19380-8, P19392-5, P19457-7, P19753-1, P19840-X, P19855-2,
P19857-6, P19858-8.
MANUFACTURER Putnam County Blood Bank, Palatka, Florida.
RECALLED BY Manufacturer, by letters dated between February 1, 1993 and
April 22, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Florida, Louisiana, Maine, Maryland, Massachusetts, New
Jersey, Tennessee, Washington, D.C. West Virginia.
QUANTITY (a) 390; (b) 205; (c) 76; (d) 62; (e) 289.
REASON Blood products, which either: 1) tested repeatedly reactive
for the antibody to the human immunodeficiency virus type 1
(anti-HIV-1); 2) tested initially reactive for anti-HIV-1
and were not retested in duplicate as required by the
manufacturer's instructions; 3) tested negative for anti-
HIV-1, but collected from donors who previously tested
reactive for anti-HIV-1; or 4) were collected from
ineligible donors due to inappropriate responses to the AIDS
donor screening questions, were distributed.
-6- _______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Platelets for
Further Manufacture; (d) Recovered Plasma.
Recall #B-315/318-3.
CODE Unit numbers: (a) H04058-4, H04549-9, H07962-6, P17037-1,
P17984-X, P18525-5, P18982-0, P19301-0, P19595-5;
(b) H06514-8, H06550-5, P17984-X, P18525-5, P18731-6,
P18982-0, P19301-0, P19595-5; (c) H07962-6; (d) H06514-8.
MANUFACTURER Putnam County Blood Bank, Palatka, Florida.
RECALLED BY Manufacturer, by letter dated March 4, 1993, and April 28,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Florida, Massachusetts.
QUANTITY (a) 9 units; (b) 8 units; (c) 1 unit; (d) 1 unit.
REASON Blood products, which either: 1) tested negative for the
antibody to human T-lymphotropic virus type I (anti-HTLV-I),
but were collected from donors who previously tested
repeatedly reactive for anti-HTLV-I on two separate
occasions; or 2) tested negative for the antibody to the
human immunodeficiency virus type 2 (anti-HIV-2), but were
collected from donors who previously tested repeatedly
reactive for anti-HIV-2, were distributed.
_______________
PRODUCT (a) Red Blood Cells;
(b) Red Blood Cells, For Further Manufacture;
(c) Red Blood Cells, Washed; (d) Platelets;
(e) Platelets, Expired; (f) Cryoprecipitated AHF;
(g) Fresh Frozen Plasma; (h) Source Leukocytes;
(i) Recovered Plasma. Recall #B-342/350-3.
Unit numbers: (a) 1951741, 2538851, 2538868, 2538876,
2538884, 2538911, 3334495, 3356872, 4504029, 5463117,
5474612, 6502885, 7202975, 10010057, 10021942, 10036761,
11382691, 11663073, 11900659, 12328749, 12334218, 12400227,
12674286, 12887079, 12925347, 13040098, 13052722, 13206895,
13207494, 13638988, 13675418, 13692882, 13762451, 13782721,
13788064, 14025985, 14168821, 15043223, 15123506, 17489773,
17503713, 17513415, 17517379, 18429972, 18915087, 20075021,
21038551, 21708941, 22586212, 23716739, 24649932, 24682352,
24913888, 25595684, 27537918, 31031152, 51003089, 51023262,
51041051, 51089484, 52000091, 52133078, 54901280, 58891994,
71702946, 95603660, 100192113, 100888826, 102142985,
102143802, 102447471, 102876068, 102893984, 103596643,
103882769, 105437249, 105815768, 107380166, 107989194,
110259670, 110280378, 111631411, 111848980, 111987906,
111988236, 112344907, 112914750, 113612569, 114056141,
114607616, 114795824, 115136381, 115137491, 115220153,
115477084, 115995725, 117143440, 117305895, 117665195,
117862153, 121241559, 121278391, 121278461, 121278634,
121278739, 121278771, 121649017, 121649162, 121733915,
121733974, 121734003, 122201412, 122365843, 122366079,
122615724, 122615767, 122834650, 124235534, 124294868,
125446462, 127733158, 128124700, 130322741, 130322766,
-7- 130322836, 130322906, 131730055, 132791569, 132791975,
134108404, 134395221, 134676401, 134727881, 134729053,
135161928, 135162161, 135650198, 137045171, 137899559,
141193944, 141298011, 141653936, 142198120, 142198658,
143792838, 143930201, 151691449, 151691718, 151691793,
151820309, 152154673, 152170226, 152468182, 152768902,
152860268, 155323974, 155968478, 160226992, 160227271,
160453021, 160453072, 160453101, 160453169, 160453177,
160453185, 160453193, 160453255, 160453263, 160453271,
160453333, 160453341, 160453351, 160453403, 160453446,
160454693, 160521521, 161412407, 161916276, 162109344,
162263428, 162544138, 165520015, 170212963, 170506393,
171753916, 171809994, 171865062, 171865097, 171865296,
171865748, 172059511, 173079825, 174255976, 175506545,
175506607, 175551398, 180632321, 180632346, 181175211,
182069835, 182775271, 182777432, 182915906, 182916071,
182945539, 182945789, 182946025, 182946310, 182946407,
183864191, 183968101, 184282921, 184483548, 184616415,
185178550, 185181937, 190552012, 191666145, 192425595,
192701613, 192701847, 195214598, 197585721, 198582531,
201777111, 203337532, 205931715, 205932002, 210907901,
211841635, 212303136, 212939836, 220654021, 220654031,
221066311, 224551075, 225380448, 225563476, 251161346,
252772452, 252789475, 255237636, 260297643, 262668696,
264400803, 267938581, 313103351, 627745486, 627748488,
807644743;
(b) 141531622, 162118377, 174751484;
(c) 770820911 771151660, 771151827;
(d) 1951741, 3334495, 4504029, 7202975, 10010057, 10036761,
11382691, 11900659, 12261170, 12400227, 12887079, 13040098,
13692882, 13782721, 13788064, 14168821, 17517379, 18915087,
22586212, 51041051, 100192113, 100888826, 101251398,
102143802, 102447471, 102876068, 102893984, 103596643,
103882769, 107380166, 107989194, 110259670, 110280378,
111631411, 111848980, 111988236, 114607616, 114795824,
115136381, 115220153, 115477084, 115995725, 117305895,
117665195, 121241559, 121278391, 121278461, 121278771,
121278798, 121649162, 121733915, 122201412, 122366079,
122615767, 122834650, 124294868, 125446462, 130322741,
130322766, 130322906, 132712753, 134676401, 134727881,
134729053, 135650198, 142198120, 143792838, 143930201,
151473691, 151691449, 151820309, 152154673, 152768902,
160088938, 160453177, 160453193, 160453255, 160453263,
160453341, 160453351, 160453368, 160453446, 160521521,
162118377, 162263428, 162544138, 165520015, 170212963,
171809994, 171865296, 172059511, 173079825, 174255976,
174751484, 175506607, 175551398, 180632321, 180632346,
182069835, 182777432, 182915906, 182946025, 183864191,
184282921, 184483548, 184616415, 190669959, 192701613,
192701847, 197585721, 198582531, 201777111, 203337532,
205932002, 212939836, 220654021, 220654031, 225380448,
251161346, 252772452, 252789475, 255237636, 264400803,
627748488;
-8- (e) 12328749, 12334218, 12674286, 12925347, 13207494,
102142985, 121278634, 122365843, 122615724, 132791569,
132791975, 137045171, 142198658, 152319603, 152860268,
162109344, 182775271, 182916071;
(f) 5474612, 13052722, 13206895, 14025985, 15043223,
103596643, 105437249, 112344837, 112914750, 115137491,
117143440, 117665195, 121278391, 121278921, 121733974,
135161928, 135162161, 137899559, 141531622, 151691793,
152170226, 155968478, 160227271, 171753916, 175506607,
175551398, 183864191, 192425595, 201777111, 212303136,
221066311, 225380448, 261043222;
(g) 2538868, 2538876, 2538884, 12328749, 12674286, 13692882,
13788064, 14168821, 17503713, 17513415, 107380166,
107989194, 115220153, 117305895, 121241559, 122365843,
128124700, 132712753, 132791975, 135650198, 137045171,
143792838, 143930201, 151820309, 152768902, 160521521,
161412407, 173079825, 174255976, 182069835, 182775271,
182916071, 183968101, 184616415, 185178550, 190669959,
195214598, 198582531, 203337532, 205931715, 205932002,
220654013, 240721920(A), 240721920(B), 240721920(C),
241488858(A), 241488858(B), 241488858(C), 241488874(A),
241488874(B), 241488874(C), 251161346, 253972310, 807644743;
(h) 11564257, 11564187, 17513415, 110280378, 134395221,
160453177, 160453271, 183968101, 195214598;
(i) 1951741, 2538851, 2538911, 3334495, 3356872, 4504029,
5463117, 5474612, 6502885, 7202975, 10010057, 10021942,
10036761, 11382691, 11663073, 11900659, 11914298, 12261170,
12334218, 12400227, 12887079, 12925347, 13040098, 13052722,
13206895, 13207494, 13638988, 13675418, 13762451, 14025985,
15043223, 15123506, 17489773, 17517379, 18429972, 20075021,
21038258, 21038551, 21708941, 22586212, 23716739, 24649932,
24682352, 24913888, 27537918, 31031152, 40113749, 51023262,
51041051, 51089484, 52000091, 52133078, 54901280, 58891994,
71702946, 95603660, 100192113, 100888826, 101251398,
102142985, 102143802, 102447471, 102876068, 102893984,
103596643, 103882769, 105437249, 105815768, 110259670,
110280378, 111631411, 111848980, 111987906, 111988236,
112344638, 112344708, 112344837, 112344907, 112914750,
113612569, 114056141, 114795824, 115136381, 115137491,
115477084, 115995725, 117143440, 117665195, 117862153,
118650769, 121278391, 121278461, 121278634, 121278739,
121278771, 121278798, 121278921, 121649017, 121649162,
121733915, 121733974, 121734003, 122201412, 122366079,
122615724, 122615767, 122834650, 124235534, 124294868,
125446462, 127733158, 130322741, 130322766, 130322836,
130322906, 131730055, 132791569, 134108404, 134395221,
134727881, 134729053, 135161928, 135162161, 137899559,
141193944, 141298011, 141531622, 141653874, 141653911,
141653936, 142198120, 142198658, 151473691, 151691449,
151691718, 151691793, 152154673, 152170226, 152319603,
152468182, 152860268, 155323974, 155968478, 160226992,
160227271, 160453021, 160453072, 160453101, 160453169,
-9- 160453177, 160453185, 160453193, 160453255, 160453263,
160453271, 160453333, 160453341, 160453351, 160453368,
160453403, 160453438, 160453446, 160454693, 161916276,
162109344, 162118377, 162263428, 162544138, 165520015,
170212963, 170506393, 171753916, 171809994, 171865062,
171865097, 171865296, 171865341, 171865748, 172059511,
174751484, 175506545, 175506607, 175551398, 180632321,
180632346, 181175211, 182777432, 182915906, 182945539,
182945789, 182946025, 182946310, 182946407, 183864191,
184282921, 184483548, 185181937, 190552012, 191666145,
192425595, 192701613, 192701847, 197585721, 201777111,
210907901, 211841635, 212303136, 212939836, 220654021,
220654031, 221066311, 224551075, 225380448, 225563476,
251859604, 252772452, 252789475, 255237636, 260297643,
261043222, 262668696, 264400803, 267938581, 313103351,
627745486, and 627748488.
MANUFACTURER J. K. and Susie L. Wadley, Research Institute and Blood
Bank, Dallas, Texas.
RECALLED BY Manufacturer, by letter November 18, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 250 units; (b) 3 units; (c) 3 units; (d) 124 units; (e)
18 units; (f) 33 units; (g) 54 units; (h) 9 units; (i) 226
units.
REASON Blood products which: 1) tested either initially reactive
without duplicate repeat testing, or repeatedly reactive, or
2) tested negative but were collected from donors who
previously tested either initially reactive without
duplicate repeat testing, or repeatedly reactive for the
antibody to the human immunodeficiency virus type 1 (anti-
HIV-1), were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Cuffed Tracheal Tubes:
(a) Catalog #5-10206, 3.0 mm Cuffed Tubes, Magil Type;
(b) Catalog #5-10206-SB, 3.0 mm Cuffed Tracheal Tubes, Magil
Type, bulk; (c) Catalog #5-10206-G, 3.0 mm Cuffed Tracheal
Tubes, Magil Type, bulk sterile, labelled in Italian;
(d) Catalog #5-10106, 3.0 mm cuffed Tracheal Tubes w/Murphy
Eye; (e) Catalog #5-10107, 3.5 mm Cuffed Tracheal Tubes
w/Murphy eye. Recall #Z-620/624-3.
CODE Lot numbers: (a) 010273, 911G004513; (b) 006370;
(c) 004513; (d) 013580; (e) 012787.
MANUFACTURER Sheridan Catheter Corporation, Argyle, New York.
RECALLED BY Manufacturer, by letter May 13, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION California, Florida, Kentucky, Louisiana, Massachusetts,
Minnesota, Missouri, New York, Oklahoma, Pennsylvania,
Tennessee, Texas, Virginia, Washington state.
-10- QUANTITY 4,861 units were distributed.
REASON Devices may have a leak in the cuff inflation circuit which
prevents cuff inflation.
_______________
PRODUCT TurboChef Combination Convection/Microwave Oven, Model C1.
Recall #Z-630-3.
CODE Serial 002.
MANUFACTURER TurboChef, New York, New York (distributor).
RECALLED BY Texas Instruments, Inc., (TI), Dallas, Texas, by letter
April 2, 1993. Firm-initiated field correction complete.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Failure to meet safety interlock concealment requirements.
_______________
PRODUCT RAHD brand Radiation Treatment Planning System Software, to
be used on the RAHD RTP System models of the 3100 and 5000
series. The software was designed to allow user-selected
archiving of patient treatment plans onto a tape cassette:
(a) Version 1.5 for System 5000 Series; (b) Version 1.5 for
System 3000 Series. Recall #Z-658/659-3.
CODE (a) RAHD 5000 serial number 15, RAHD 5000D serial number 15,
RADH 5200 serial number 10; (b) Version 1.5.
MANUFACTURER Electronic Services Mart, Inc., St. Louis, Missouri.
RECALLED BY Manufacturer, by telephone February 1993, and by mail March
3, 1993. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 15 software packages were distributed.
REASON There is a potential for corrupting the patient files and
for the user to be unable to retrieve the patient treatment
plan.
_______________
PRODUCT CT Scanners, Model TCT-500S. Recall #Z-673-3.
CODE All units.
MANUFACTURER Toshiba, Japan.
RECALLED BY Toshiba America Medical Systems, Inc., Tustin, California,
FDA approved the firm's corrective action plan August 5,
1993. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 35 units.
REASON Product failed to provide computed tomography dose index
(CTDI) specifications for all required sites.
_______________
PRODUCT BLD brand Neonatal Humidification Chamber, used to deliver
warmed, humidified gas to a patient. Recall #Z-683-3
CODE Lot numbers: 239049, 246008, 250052, 301081, 301125,
312041.
MANUFACTURER Bird Life Design, Carrollton, Texas.
-11- RECALLED BY Manufacturer, by letter July 6, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Florida, Georgia, Indiana, Minnesota, Mississippi,
Pennsylvania, Tennessee.
QUANTITY 109 cases (30 units per case) were distributed.
REASON The gas inlet port may be occluded by a thin layer of
plastic preventing anesthesia and respiratory gases from
reaching the neonatal patient, and possibly resulting in
patient apnea.
_______________
PRODUCT Breath Tracker Model 1705, a battery powered microprocessor
controlled device for use with patients on respiratory
support systems. Recall #Z-684-3.
CODE All 1705 models containing version B software.
MANUFACTURER Core-M, L.P., Allston, Massachusetts.
RECALLED BY Manufacturer, by letter October 1, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Italy, Japan, Mexico.
QUANTITY Approximately 800 units were distributed.
REASON The device may not properly display a low battery condition,
resulting in an under reading of actual airway pressure.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
=========
_______________
PRODUCT Elanco brand Tylan Concentrate, in 1,000 pound totes, a high
potency granular animal drug intended for further
manufacturing or processing. Recall #V-030-3.
CODE 956DA2.
MANUFACTURER Eli Lilly & Company, Clinton, Indiana.
RECALLED BY Eli Lilly & Company, Indianapolis, Indiana, by telephone
October 15, 1992. Firm-initiated field correction
(relabeling) complete.
DISTRIBUTION Illinois, Texas.
QUANTITY 8 totes were distributed.
REASON Product was mislabeled for potency.
_______________
PRODUCT Turkey Prestarter, containing neomycin sulfate in
combination with oxytetracycline HCl, a bulk custom mix
medicated feed for turkeys. Recall #V-039-3.
CODE Custom Mix #93005, Turkey Prestarter Formulation 3110,
Batch #525910.
MANUFACTURER Countrymark Cooperative, Inc., doing business as Loogootee
Feed Mill, Loogootee, Indiana.
RECALLED BY Countrymark Cooperative, Inc., Indianapolis, Indiana, by
telephone September 16, 1992. Firm-initiated recall
complete.
DISTRIBUTION Indiana.
QUANTITY 1 4,000-pound bulk batch was distributed.
-12- REASON Custom mix batch superpotent in neomycin and oxytetracycline
due to manufacturing error.
_______________
PRODUCT Life Cycle Co-op Beef Base Mix LS-1440, Medicated 0936, in
50 pound bags, used in beef cattle for improved feed
efficiency. Recall #V-040-3.
CODE 31736Z.
MANUFACTURER Countrymark Cooperative, Inc., Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone July 1, 1992. Firm-initiated
recall complete.
DISTRIBUTION Indiana.
QUANTITY 118 bags was distributed.
REASON Product is subpotent in Lasalocid Sodium.
MEDICAL DEVICE SAFETY ALERTS:
=============================================
_______________
PRODUCT N-6000 Ultra-Cap Pulse Oximeter and Capnograph, used to
measure carbon dioxide, oxygen levels, respiratory rates,
and pulse rates. Safety Alert #N-057-3.
CODE All serial numbers.
MANUFACTURER Nellcor, Inc., Hayward, California.
ALERTED BY Manufacturer, by letter April 15, 1993.
DISTRIBUTION Nationwide.
QUANTITY 437 units were distributed.
REASON Electromagnetic interference (62.5 kHz) from the power
supply of the subject device can cause artifacts and false
readings on certain thoracic impedance pneumography (TIP)
respiratory monitors operating at or near the same
frequency.
_______________
PRODUCT Ultra-X External Fixation System Clamps and couplings, major
components of the Ultra-X External Fixaton System, used for
external fixation of traumatic fractures in long bones and
joints: (a) Catalog #5129-1-508, Double Pin-to-Rod Clamp;
(b) Catalog #5129-2-508, Rod-to-Rod Clamp;
(c) Catalog #5129-3-508, Pin-to-Rod Clamp.
Safety Alert #N-060/062-3.
CODE All lots.
MANUFACTURER Howmedica Division of Pfizer Hospital, Rutherford, New
Jersey.
ALERTED BY Manufacturer, by letter February 8, 1993.
DISTRIBUTION Nationwide.
QUANTITY (a) 8,370 units; (b) 11,945 units; (c) 19,985 units were
distributed.
REASON Clamp cracking and breakage during cleaning.
-13-
SEIZURES:
================================================================
_______________
PRODUCT Elephant fish fillets (93-661-755/6).
CHARGE Adulterated - The articles consist in whole or in part of
decomposed seafood.
FIRM Fulton Market Cold Storage, Chicago, Illinois.
FILED July 14, 1993; U.S. District Court for the Northern District
of Illinois, Eastern Division; Civ. #93C 4228; FDC #66743.
SEIZED July 19, 1993 - goods valued at approximately $10,000.
_______________
PRODUCT Ear cones (a wax-coated hollow cylinder used to remove ear
wax by lighting the top of the candle-like device and
allowing it to create a vacuum in the ear) (93-670-000).
CHARGES Adulterated - The article is a class III medical device for
which there is no approved premarket approval application in
effect. Misbranded - The article's labeling represents and
suggests that it is adequate and effective for treating
hearing and sinus problems, headaches, and ear infections,
which representations and suggestions are contrary to fact.
The article's labeling fails to bear adequate directions for
the purposes for which it is intended; and, it is dangerous
to health when used in the manner recommended and suggested
in its labeling. The article was manufactured, prepared,
propagated, compounded, and processed in an establishment
not duly registered as required; and, no notice or other
required information was filed.
FIRM Awareness and Health Unlimited, Columbus, Ohio.
FILED July 28, 1993; U.S. District Court for the Southern District
of Ohio, Eastern Division; Civ. #C2-93-750; FDC #66746.
SEIZED July 30, 1993 - three cases, valued at approximately $200.
-14-
END OF ENFORCEMENT REPORT FOR AUGUST 18, 1993. BLANK PAGES MAY
FOLLOW.
####