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
01/05/1994
Recalls and Field Corrections: Foods -- Class III -- 01/05/1994
January 5, 1994 94-1
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Soda in glass bottles labeled in part: "All Natural
Snapple Creme D'Vanilla Soda 16 fl oz." Recall #F-162-4.
CODE Lot numbers: 082594 1500-2400, 082694 0001-0700.
MANUFACTURER Canada Dry Silver Spring, Silver Spring, Maryland.
RECALLED BY Snapple Beverage Corporation, Valley Stream, New York, by
letter November 24, 1993. Firm-initiated recall ongoing.
DISTRIBUTION New York, Pennsylvania .
QUANTITY 10,854 cases (24 bottles per case) were distributed.
REASON Product is contaminated with mold.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Erythromycin Stearate Tablets, Rx, oral antibiotic tablet,
(a) 250 mg in bottles of 100 under the following labels:
Zenith, Major, Goldline, URL, in bottles of 500 under the
following labels: Goldline, Schein, Rugby, Zenith, Major,
in bottles of 1,000 under the Schein and Rugby labels;
(b) 500 mg, in bottles of 100 under the following labels:
Zenith, Major, Goldline, Schein, Rugby.
Recall #D-076/077-4.
CODE Lot numbers: (a) 2458-166V EXP 4/95, 2458-168 EXP 4/95,
2458-169 EXP 5/95; (b) 2823-060 EXP 5/96, 2823-061 EXP
5/96.
MANUFACTURER Zenith Laboratories, Inc., Northvale, New Jersey.
RECALLED BY Manufacturer, by letter dated September 27, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated 268,640 250-mg tablets and 96,430 500-mg
tablets remained on market at time of recall initiation.
REASON Products do not meet dissolution specifications.
_______________
PRODUCT Sterile antibiotic powders for intramuscular or
intravenous injection upon reconstitution: (a) Sterile
Ampicillin Sodium USP 500 mg/6 ml vial, 6 ml multiple dose
vials shipped as 10-6 ml vial shelf packs, 10 shelf packs
per shipper;
(b) Oxacillin Sodium for Injection USP 500 mg per 6 ml
vial, 6 ml multiple dose vials shipped as 10 6-ml vial
shelf packs, 10 shelf packs per shipper;
(c) Nafcillin Sodium for Injection USP 1 gm per 20 ml
vial, 20 ml multiple dose vial shipped as 10 20-ml vial
shelf packs, 10 shelf packs per shipper. Recall #D-
078/080-4.
CODE Lot numbers: (a) 3A60243 EXP 1/96; (b) 2J40160 EXP 9/94;
(c) 2K50204 EXP 10/95.
MANUFACTURER Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
RECALLED BY Manufacturer, by letter dated October 13, 1993. Firm-
initiated recall complete.
DISTRIBUTION (a) Canada, Russia; (b) Tennessee, Nevada;
(c) Nationwide and Puerto Rico.
QUANTITY (a) 59,300 vials; (b) 5,590 vials; (c) 14,810 vials were
distributed. Firm estimates (a) none; (b) none; (c) 25-
50% of product may be commercially available.
REASON Potency not assured through expiration date.
_______________
PRODUCT 18 pharmaceutical dosage forms of 12 drug products which
are under voluntary recall by the manufacturer. The 12
recalled drug products, including applicable dosage forms,
are as follows (package sizes are indicated within the
parentheses):
(a) Amitriptyline HCl Tablets, 50 mg: (100, 500, 1000)
(b) *Chlorthalidone Tablets, 50 mg: (100, 500, 1000)
(c) *Hydroxyzine HCl Tablets, 10 mg, 25 mg, 50 mg: (for
each: 100, 500, 1000);
(d) *Hydroxyzine Pamoate Capsules 25 mg, 50 mg: (for each:
100, 500, 1000)
(e) Indomethacin Capsules, 25 mg: (100,500,1000); 50 mg:
(100, 250, 500)
(f) Methylprednisolone Tablets 4 mg: (100, Blister)
(g) Phenylbutazone Capsules 100 mg: (100)
(h) Phenylbutazone Tablets, 100 mg: (100, 500, 1000)
(i) Probenecid Tablets, 500 mg: (100, 1000)
(j) Procainamide HCl Capsule, 375mg: (100) 500mg: (100,
1000)
(k) Spironolactone Tablets 25 mg: (100, 500, 1000)
(l) Sulfamethoxazole & Trimethoprim Tablets 400/80 mg:
(100, 500) 800/160 mg: (100, 500). *These products were
manufactured at the Chelsea Puerto Rico manufacturing
facility. Recall #D-081/098-4.
CODE All lots.
MANUFACTURER Chelsea Laboratories, Inc., Monroe, North Carolina;
Chelsea Laboratories, Inc., Bayamon, Puerto Rico.
RECALLED BY Chelsea Laboratories, Inc., Monroe, North Carolina, by
letter November 12, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY The following amounts were distributed:
Amitriptyline - 72552/100's, 4866/500's, 18956/1000's
Indomethacin, 25 mg - 65330/100's, 5496/500's,
17113/1000's
Indomethacin, 50 mg - 54906/100's, 1098/250's,
9708/500's
Methylprednisolone, 4 mg - 148518/100's,
1310076/blister
Probenecid, 500 mg - 42576/100's, 3170/1000's
Phenylbutazone, 100 mg - 18648/100's
Phenylbutazone, 100 mg - 79400/100's, 1173/500's
1074/1000's
Procainamide, 375 mg - 9948/100's
Procainamide, 500 mg - 27972/100's, 091/1000's
Spironolactone, 25 mg - 69534/100's, 41190/500's
17778/1000's
Trimeth/Sulfa - 154612/100's, 114157/500's
Chlorthalidone, 50 mg - 52211/100's 1400/500's,
2672/1000's
Hydroxyzine HCl, 10 mg - 208218/100's, 9730/500's
12387/1000's
Hydroxyzine HCl, 25 mg - 410747/100's, 30220/500's
24965/1000's
Hydroxyzine Pamoate, 50 mg - 205568/100's, 23862/500's
7202/1000's
Hydroxyzine HCl, 50 mg - 87285/100's, 3586/500's,
5460/1000's
Hydroxyzine Pamoate 25 mg - 300682/100's; 31101/500's
11655/1000's
The firm estimates that approximately <50 % of these
products remain on the market.
REASON Abbreviated New Drug Application discrepancies.
_______________
PRODUCT Compressed Medical Oxygen in D & E size cylinders.
Recall #D-099-4.
CODE All fill dates.
MANUFACTURER Chief Fire and Safety Equipment Distributors, Inc., Port
Washington, New York.
RECALLED BY Manufacturer, by letter December 23, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY Undetermined.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Tempo Soft Antacid, packaged in 10 and 60 individually
foil wrapped containers. Recall #D-075-4.
CODE Lot numbers: T0293A EXP 8/95 (10's); T0293D EXP 8/95
(60's).
MANUFACTURER American Candy Company, Oklahoma City, Oklahoma.
RECALLED BY Thompson Medical Company, Inc., West Palm Beach, Florida,
by letter September 22, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 1,035 dozen - 10's only; 326 dozen - 60's only were
distributed; firm estimates 1,015 dozen of lot T0293A and
134 dozen of lot T0293D remain on the market.
REASON Possible presence of metal particles.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Phase Doppler Particle Analyzer (PDPA) and Laser Doppler
Velocimeter (LDV) Model 1100, 1200 with external laser,
Model 1200, Fiber Drive, FBD 1120 and 1140 with HeNe, FBD
1120 and 1140 with external laser, and the XMT series of
probes. These products are instruments and accessories
for analyzing particle field and fluid flow. Recall #Z-
245-3.
CODE Not applicable.
MANUFACTURER Aerometrics, Inc., Sunnyvale, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan December 16, 1992. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide.
QUANTITY 41 units.
REASON Various models failed to have adequate protective housings
(laser beam enclosures), labels, and operating
instructions.
_______________
PRODUCT Version UPS V9.11 Software for Nucletron Planning System
(NPS), used with the MicroSelectron High Dose Rate
Afterloading System (MHDR). Recall #Z-111-4.
CODE All NPS units and All MHDR units.
MANUFACTURER Nucletron B.V., Waargelder 1, The Netherlands.
RECALLED BY Nucletron Corporation, Columbia, Maryland, by Technical
Notes dated April 5, 1991. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide, Argentina, Brazil, Canada, Colombia, Mexico,
Venezuela, West Indies.
QUANTITY 231 NPS units and 242 MHDR units.
REASON The device contains inadequate directions for use. The
firm's upgrade of the MHDR software to Version 3.31
allowed the user to choose either 2.5 mm or 5.0 mm as the
unit step length in defining the location of the
radioactive source. The NPS V9.11 software, however,
while allowing the user to employ either step length in
the planning session, did not write the manually entered
step length to the program card. Instead, the step length
value in the "customizing file" would be transferred via
program card to the MHDR. If the user failed to update
the "Separation of Dwell Positions" parameter in the NPS
"customizing file," the positioning of the radioactive
source could be grossly in error. The lack of adequate
directions for use of the NPS could result in
misadministration of dosage to the patient.
_______________
PRODUCT Shiley Single Cannula Tracheostomy Tube, Sizes 7 and 8,
and Shiley Specialized Single Cannula Tracheostomy Tube,
Sizes 7 and 8, used to establish airway in compromised
patients.
Recall Nos. Z-134/137-4.
CODE (a) Model 7SCT Single Cannula Cuffed Tracheostomy Tube
9390046100 9399034600 9399018000
9399006300 9399015200
(b) Model 8SCT Single Cannula Cuffed Tracheostomy Tube
9390042300 9399023400 9399029400
9399006000 9399023500 9399029500
9399015500 9399029300
(c) Model M7SCT Specialized Single Cannula Cuffed
Tracheostomy Tube
3013460000 3015370000 3017600000
3014090000 3015500000 3018100000
3014690000 3016220000 3018170000
3014800000 3016990000 3016820000
3015170000 3017480000
(d) Model M8SCT Specialized Single Cannula Cuffed
Tracheostomy Tube
3012170000 3010270000 3011650000
3012290000 3010330000 3011960000
3012310000 3010600000 3012510000
3012400000 3011160000 3012650000
3012480000 3011220000 3012790000
3010000000 3011470000 3013010000
3010200000 3011610000 3010020000
3013370000 3016850000 3009430000
3013430000 3016940000 3009580000
3013480000 3017190000 3009590000
3013530000 3017670000 3009750000
3013650000 3007620000 3015480000
3013780000 3007830000 3016460000
3014100000 3007950000 3018180000
3014110000 3008060000 3018460000
3014550000 3008140000 3018650000
3014740000 3008370000 3018690000
3014790000 3008380000 3018700000
3014850000 3008410000 3018740000
3014920000 3008420000 3018810000
3014940000 3008430000 3018850000
3014960000 3008450000 3019000000
3015300000 3008470000 3019090000
3015380000 3008530000
3015590000 3008610000
3015680000 3008770000
3015890000 3008800000
3015920000 3008880000
3016030000 3009000000
3016210000 3009160000
3016290000 3009300000
3016310000 3009310000
3016710000 3009380000
MANUFACTURER Mallinckrodt Medical TPI, Inc., Irvine, California.
RECALLED BY Manufacturer, by letter dated August 9, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Mexico, Taiwan, Australia, Puerto Rico,
Germany.
QUANTITY 2,225 units were distributed; firm estimates 50 units
remain on the market.
REASON Inflation system may leak, thereby compromising the
patient breathing circuit. This leak may result in a
deflation of the cuff that holds the tracheostomy tube in
place and prevents air from bypassing the tracheostomy
tube.
_______________
PRODUCT Spherical Hydrophilic Contact Lens:
(a) Hydron Z-6 lens, labeled clear instead of tinted;
(b) Hydron Z-4 Lens, labeled 1.00 instead of -5.00;
(c) Hydron Z-4 Lens, labeled -1.00 instead of -5.00;
(d) Hydron Z-6 Lens, labeled +3.25 instead of +3.75.
Recall #Z-157/160-4.
CODE (a) B30091; (b) B30209; (c) E20384; (d) PRA01001.
MANUFACTURER OSI American Hydron, Santa Isabel, Puerto Rico;
Precision Lens Lab, Hampshire, England.
RECALLED BY Ocular Sciences American Hydron, South San Francisco,
California, by telephone during week of August 9, 1993 and
by letter dated August 13, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 56 lenses were distributed.
REASON Labels indicate incorrect power(s) or color.
_______________
PRODUCT Laparotomy Sponges in 18" X 18", 12" X 12", 4" X 8", and
8" X 36" sizes in various Procedure Packs.
Recall #Z-169/172-4.
(a) 18" X 18" Lap Sponges in Procedure Pack Catalog Nos.:
AB110, AB1110, AB200, AB201, AB2062, AB480, AB517,
ACL530, AR207, AR210, AR240, AR960,BI968, BN250, BN516,
BN520, BN542, BN580, BN669, BN1470, BN1490, BP215,
BP350, BP465, BP470, BP471, BP537, BP546, BP710, BP722,
BP944, BP945, BP995, BP1165, BT1200, CH100, CH311, CH325,
CH936, CN1400, CN175, CN271, CN286, CN288, CN444, CN718,
CN725, CN733, CS100, CS1100, CS111, CS125, CS130, CS140,
CS171, CS202, CS595, CS2130, CS2133, CS233, CS255, CS260,
CS285, CS300, CS303, CS305, CS307, CS325, CS364, CS433,
CS435, CS438, CS440, CS456, CS511, CS516, CS520, CS526,
CS536, CS573, CS580, CS590, CS595, CS625, CS627, CS675,
CS735, CS760, CS800, CS816, CS823, CS825, CS875, CS890,
CS946, CS966, CS967, CS990, CV1000, CV1008, CV1052,
CV1107, CV1109, CV1110, CV1120, CV1125, CV1400, CV1401,
CV1450, CV200, CV2010, CV2015, CV210, CV211, CV212, CV214,
CV267, CV271, CV278, CV286, CV295B, CV300, CV394, CV395,
CV396, CV420, CV427, CV440, CV450,CV452, CV453, CV460,
CV461, CV472, CV515, CV522, CV543A, CV543B, CV545, CV547,
CV550, CV561A, CV585, CV590, CV591, CV622, CV625, CV650,
CV685B, CV801, CV802, CV803, CV804, CV805, CV807, CV835,
CV840, CV860, CV875, CV880, CV885, CV945, CV960, CV982,
DO927, DO929, DO931, DO932, ENT276, EX331, EX510, EX675,
EX722, FF100, GB202, GS528, GYN790, HP209, HP610, KD318,
LBC720, LC1400, LC211, LC270, LM105, LM202, LM517, LM770,
LP100, LP1169, LP2111, LP200, LP385, LP418, LP517, LP532,
LP730, LP785, LP850, MB1020, MJ1100, MJ1155, MJ1410,
MJ2500, MJ517, MJ526, MN1156, MN525, MP100, MP201, MP205,
MP207, MP252, MP255, MP285, MP629, OB778, OB872, OR1150,
OR2110, OR200, OR222, OR262, OR291, OR339, OR376, OR417,
OR469, OR575, OR580, OR625, OR630, OR655, OR710, OR736,
OR995, OT901, OT904, OT945, OT985, PK277, PV285, PV290,
SH1149, SH249, SH320, SH510, SH600, TH1100, TH1135,
TH1152, TH150, TH200, TH201, TH2045, TH2050, TH208, TH212,
TH213, TH259, TH264, TH277, TH289, TH295, TH300,
TH345, TH416, TH460, TH476, TH525, TH537, TH563, TH789,
TH945, TH960, TH968, TK200, TK960, TK968, TK0069,
TN1154, TN243, TN277, TN292, TN318, TN362, TN417,
TN427, TN435, TN542, TN766;
(b) 12" X 12" Lap Sponges in Procedure Pack Catalog Nos.:
BN538, BN540, BN593, CS542, EX2510, OR588, TN561, TN562;
(c) 4" X 18" Lap Sponges in Procedure Pack Catalog Nos.:
DR504, GN995, IVF909, LBC720, LP100, LP532, TH277, TH525,
TN590;
(d) 8" X 36" Lap Sponges in Procedure Pack Catalog No.
SU388.
MANUFACTURER Associated Medical Products Company, Minnetonka, Minnesota
RECALLED BY Manufacturer, beginning October 26, 1993, and by letter
November 22, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY Nationwide and Canada.
REASON A number of packs tested by FDA and the firm found
laparotomy sponges to be nonsterile.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Emit 2000 Digoxin Calibrator Kits, for in-vitro diagnostic
use with the EMIT 2000 Digoxin Assay. Recall #Z-094-4.
CODE Lot numbers: F1, Sublots F1A and F1B, Lot F2.
MANUFACTURER Syva Company, San Jose, California.
RECALLED BY Manufacturer, by letter dated November 9, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimated 1,619 kits were in commerce as of October
26, 1993.
REASON Some of the calibrators of the calibration kit were
contaminated with microbials.
_______________
PRODUCT Software for Nucletron Planning System (NPS) and the
MicroSelectron High Dose Rate Afterloading System (MHDR):
(a) Software for NPS (Version 9.11);
(b) Software for MHDR (Version 3.2). Recall #Z-109/110-4.
CODE All Nucletron Planning Systems.
MANUFACTURER Nucletron B.V., Waardgelder 1, The Netherlands.
RECALLED BY Nucletron Corporation, Columbia, Maryland, by Technical
Notes issued in August 1990. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide and South America.
QUANTITY 231 NPS units and 242 MHDR units.
REASON Products contain inadequate directions for use. When a
new radioactive source is installed in the MHDR, the user
must update the value of the source activity in the NPS
"customizing file" with the same value that is entered
into the MHDR control unit. If this is not done, then the
NPS treatment planning session exposure times will be
based on a different source activity than that in the
MHDR. In this case, the MHDR software will adjust
exposure times in an attempt to compensate for the
perceived differences in activity values. Furthermore,
users may be mislead to believe that the "manually
specified activity" allowed in the NPS planning session,
is the activity value which will
be read by the MHDR when the planning session parameters
are transferred via program card. This is not true; the
NPS "customizing file" activity will be transferred to the
MHDR via program card regardless of the manually entered
value.
This "customizing file" value can only be changed by
updating the "customizing file."
_______________
PRODUCT (a) CLOTtrac LR Abnormal Control, used to confirm the
performance of the HemoTec Automted Coagulation Timer
(ACT) and cartridges or other versions and methodologies
of the activated clotting time test;
(b) Calcium Chloride Solution used in the reconstitution
of HemoTec LR ACT Cartridges, used to monitor the
performance of the firm's Automated Coagulation Timer
(ACT).
Recall #Z-173/174-4.
CODE (a) Catalog #550-09, lot #409039-230; (b) Catalog #550-11,
lot #409064.
MANUFACTURER Medtronic HemoTec, Englewood, Colorado.
RECALLED BY Manufacturer, by telephone October 29, 1993, followed by
letters issued on or about November 2, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 27 single-unit boxes; (b) 36 single-unit boxes were
distributed.
REASON The Calcium Chloride was misformulated and possibly
contaminated. The Calcium Chloride was then used to
establish the clotting time range for CLOTtrac Low Range
(LR) Abnormal Control.
-9-
END OF ENFORCEMENT REPORT FOR JANUARY 5, 1993. BLANK PAGES MAY
FOLLOW.
####