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
12/29/1993
Recalls and Field Corrections: Drugs -- Class II -- 12/29/1993
December 29, 1993 93-52
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
========================
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PRODUCT Eldepryl Tablets (5 mg), in 60-tablet glass bottles,
indicated in the management of Parkinson's patients.
Recall #D-059-4.
CODE All bottles with labels identifying the manufacturing
location as Danville, New Jersey.
MANUFACTURER Undetermined.
RECALLED BY James Brudnick, Company, Inc., Malden, Massachusetts, by
telephone September 10, 1993. Firm-initiated recall
complete.
DISTRIBUTION Massachusetts.
QUANTITY 2,680 bottles were distributed.
REASON Lack of assurance of product origin and authenticity.
_______________
PRODUCT Evac-U-Gen Laxative Chewable Tablets, packed in 35 count,
100 count, 500 count, 1000 count and 6000 count bottles.
Recall #D-062-4.
CODE Lot numbers: 3525 through 3532, 3534 through 3539, 142.
MANUFACTURER Walker Corporation & Company, Inc., Syracuse, New York.
RECALLED BY Manufacturer, by letter December 1, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Lot # Tablets Distributed
3525 539,900
3526 533,300
3527 538,500
3528 535,300
3529 533,300
3530 539,900
3531 530,000
3532 538,600
142 (was 3533) 535,290
3534 535,400
3535 534,100
3536 535,400
3537 538,900
3538 528,900
3539 539,200
Firm estimates approximately 5% remain on the market.
REASON Possible presence of metallic wire.
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PRODUCT (a) Sterile Water in clear glass containers for prescription
compounding of parenteral nutrition solutions, in 500 ml and
1000 ml sizes;
(b) Ringer's Injection in clear glass containers for the
provision of electrolytes and water for hydration, sold in
500 ml glass containers;
(c) 3% Sodium Chloride Injection in clear glass containers
for the provision of electrolytes and water for hydration,
sold in 500 ml glass containers;
(d) 0.45% and 0.9% Sodium Chloride Injection in clear glass
containers for the provision of electrolytes and water for
hydration, sold in 500 ml and 1000 ml glass containers;
(e) Clear Glass Empty Evacuated containers for IV Admixture,
sold in 250 ml, 500 ml, and 1000 ml sizes.
Recall #D-064/068-4.
CODE Product Lot No.
Ringer's Injection J1D054
0.9% NACL (1000 ml) J0N042, J1A063, J1C049,
J1J002, J1N028, J1P025, J3B071
0.9% NACL (500 ml) J1B053, J1C012, J1C039,
J1D035, J1D049, J1D064,
0.9% NACL (150/250 ml) J1J040
0.9% NACL (150/250 ml) J1L055, J1P046, J3A109,
J3D104, J3J0994
0.45% NACL (1000 ml) J0N041, J1D015
0.45% NACL (500 ml) J1C038, J1H026, J1N014
3% NACL (500 ml) J0P049 J1C027, J1D038
J1J038, J1K040
Sterile Water (1000 ml) J1L048, J1L057, J1N021, J1N056,
J1P004, J1P019, J1S001, J1S023
-2- Sterile Water (500 ml) J1L020, J1L035, J1L052, J1N018,
J1N035, J1N050, J1N063, J1P008,
J1P042
Evacuated Glass J0L015, J0N027, J0N059
(1000 ml) J0P041, J0S001, J1A022,
J1A062, J1B025, J1C024,
J1D040, J1E011, J1E024,
J1E035, J1E043, J1E057,
J1H018, J1H034, J1H049,
J1H062, J1J017, J1J030,
J1J044, J1J062, J1K017,
J1K033, J1L011, J1L032,
J1L045, J1L061, J1N027,
J1N055, J1P024, J1S022, J2B023
Evacuated Glass J1A017, J1B009, J1E002,
(500 ml) J1E020, J1E049, J1H038,
JiJ005, J1J053, J1J070,
J1K009, J1K037, J1L019,
J1L051, J1N038
Evacuated Glass J1D025, J1E015, J1E030,
(250 ml) J1E042, J1H029, J1H041,
J1H056, J1J008, J1J026,
J1J056, J1J074, J1K026,
J1K043, J1L006, J1L023,
J1L054, J1N005, J1N025,
J1N066, J1P011, J1P028,
J1S016.
MANUFACTURER McGaw, Inc., Irvine, California.
RECALLED BY Manufacturer, by letter September 22, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Hong Kong, Saudi Arabia, Switzerland,
Guam, Puerto Rico.
QUANTITY 1,548,204 units were distributed; FDA Los Angeles District
Office estimates very little product remains in commerce.
REASON Excess alkalinity resulting from Type II glass breakdown.
_______________
PRODUCT Cephradine for oral suspension, USP 125 mg/5ml, Rx
antibiotic, under the Biocraft, Goldline and Schein labels.
Recall #D-070-4.
CODE Lot #51929 EXP 1/1/94.
MANUFACTURER Biocraft Laboratories, Inc., Elmwood Park, New Jersey.
RECALLED BY Biocraft Laboratories, Fair Lawn, New Jersey, by telephone
followed by letter August 6, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 12,960 bottles were distributed.
REASON Subpotency.
_______________
PRODUCT Acetaminophen Pediatric Suppositories, USP 120 mg, packaged
in tamper-resistant sealed foil, nonprescription under G&W
Laboratories and Qualitest labels. Recall #D-071-4.
-3- CODE Lot numbers: 2226-1 EXP 8/94, 2226-2 EXP 8/94, 2197-2 EXP
8/94, 2244-2 EXP 9/94, 3104-5 EXP 4/95;
MANUFACTURER G&W Laboratories, Inc., South Plainfield, New Jersey.
RECALLED BY Manufacturer, by letter dated August 2 and 3, 1993, and
November 3, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Amount manufactured and shipped:
Acetaminophen Suppositories 120mg Lot #2226-1 (G&W Label)
22,992 boxes X 12 Suppositories;
Acetaminophen suppositories 120mg Lot #2197-2, 18,600 boxes
X 12 suppositories (G&W Label);
Acetaminophen Suppositories 120mg Lot #2244-2 23,148 boxes X
12 suppositories (G&W Label);
Acetaminophen suppositories 120 mg 2226-2 (Qualitest label);
3,840 boxes X 12 suppositories under Qualitest label;
Acetaminophen Suppositories 120mg 2226-2 (G&W label), 6,144
boxes X 12 suppositories, 960 boxes X 50 suppositories, and
121,728 individual suppositories under a G&W label were
distributed.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Novolin R-Regular, Human Insulin Injection (recombinant DNA
origin), USP 10 ml vial 100 units/ml, used in the treatment
of diabetes. Recall #D-072-4.
CODE Lot numbers: 2D54087, 2D54088 EXP 4/1/95. Only portion of
lots shipped to FoxMeyer are under recall.
MANUFACTURER Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark.
RECALLED BY Novo Nordisk Pharmaceuticals, Inc., Princeton, New Jersey,
by letters of August 20 and 26, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Arkansas, Colorado, Florida, Illinois, Louisiana, Missouri,
Ohio, Oklahoma Texas, Wisconsin.
QUANTITY 13,800 vials were distributed.
REASON Adverse storage conditions at distributor caused the product
to have cloudy appearance.
_______________
PRODUCT Liquid Medical Oxygen in cryogenic patient home units.
Recall #D-073-4.
CODE All fill dates.
MANUFACTURER HME Associates, doing business as For The Home Respiratory
and Medical Equipment, Great Neck, New York.
RECALLED BY Manufacturer, by visit from December 2, 1993, to December 5,
1993. Firm-initiated recall complete.
DISTRIBUTION New York, New Jersey, Connecticut.
QUANTITY 6 units were distributed. Firm recovered all 6 units.
REASON Current good manufacturing practice deficiencies.
-4- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
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PRODUCT Lyphomed Phenytoin Sodium Injection, USP, 250 mg (50 mg/ml),
5 ml single-dose vials, Rx IV or IM injectable for the
control of status epilepsy. Recall #D-060-4.
CODE Lot numbers 320767 EXP 1/94.
MANUFACTURER Fujisawa USA, Inc., Grand Island, New York.
RECALLED BY Fujisawa USA, Inc., Deerfield, Illinois, by letter December
6, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Hong Kong, Singapore, Spain.
QUANTITY 66,825 vials were distributed; firm estimates that less than
2 percent of the product remains on the market.
REASON Presence of particulate matter.
___________
PRODUCT Erythromycin Topical Solution, Rx 2%, 60 ml, under the
following labels: Bausch & Lomb, Major, Schein, Qualitest,
Genetco, Del-Ray, Harber, Goldline, Rugby, United Research
Labs. Recall #D-061-4.
CODE All lot numbers which are:
0508 0563 0578 0579 0595 0607 0641
0608 0653 0654 0690 0700 0704 0732
0733 0773 0789 0806 0831 0834 0860
0898 0908 0918 0971 1145 1169 1170
1171 1203 1207 1252 1254 1292 1305
MANUFACTURER Pharmafair, Hauppauge, New York.
RECALLED BY Bausch & Lomb, Tampa, Florida, by letter October 11, 1993.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 434,167 units were distributed.
REASON Container leakage.
_______________
PRODUCT Barnes-Hind HEB Cream Base, a pharmaceutical necessity
developed for pharmacists to compound dermatology drugs, in
1 pound jars. Recall #D-063-4.
CODE Lot numbers: M248B EXP 12/94, M249B EXP 12/94,
M250B EXP 2/94, C236C EXP 3/95, C237C EXP 3/95, C215D EXP
3/96, C216D EXP 3/96.
MANUFACTURER Paco Pharmaceutical Services, Lakewood, New Jersey.
RECALLED BY Paragon Vision Sciences, Phoenix, Arizona (responsible
firm), by letter, November 8, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 11,710 units were distributed; FDA Los Angeles District
Office estimates 2,000 units remain in commerce.
REASON Presence of mold.
_______________
PRODUCT Uticort, Betamethasone benzoate Lotion 0.025%, in 60 ml
bottles, topical Rx glucocorticoid. Recall #D-069-4.
CODE Lot #01632B EXP 3/94.
-5- MANUFACTURER Parke-Davis Division of Warner-Lambert, Inc., Brockville,
Ontario, Canada.
RECALLED BY Warner-Lambert Company, Parke-Davis Division, Morris Plains,
New Jersey, by letter August 26, 1992. Firm-initiated
recall ongoing.
QUANTITY 3,694 bottles were distributed.
REASON Subpotency.
_______________
PRODUCT Digoxin Elixir Pediatric (Digoxin), 50 ug (0.05 mg) per ml,
a oral solution for oral use in infants and children,
packaged in 60 ml glass bottles. Recall #D-074-4.
CODE Lot #2N9 EXP 2/94.
MANUFACTURER Liquipharm, Inc., Los Angeles, California.
RECALLED BY Manufacturer, by letter December 1, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION California, Florida, Georgia, Illinois, Indiana, Kentucky,
Maine, New Jersey, New York, Tennessee, Texas.
QUANTITY 1,382 units were distributed.
REASON Label lacks a complete strength designation statement.
Package insert bears the complete statement.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
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PRODUCT Anti-Fyb Blood Grouping Reagent. Recall #B-098-4.
CODE Lot numbers: FYB26A and FYB26B EXP 3/1/94.
MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan, New Jersey.
RECALLED BY Manufacturer, by letter June 1, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 810 vials of lot FYB26A and 360 vials of lot FYB26B. Firm
received and disposed of all recalled product.
REASON Anti-Fyb blood grouping reagent, exhibiting decreased
reactivity with Fyb positive red blood cells, was
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
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PRODUCT CoeSteril Sterilizing and Disinfecting Concentrate Solution,
promoted within the dental industry:
(a) Product #10-5400, 16-ounce container;
(b) Product #10-5416, 1.6-ounce container.
Recall #Z-095/096-4.
CODE All lots.
MANUFACTURER Metrex Research Corporation, Parker, Colorado.
RECALLED BY Manufacturer, by letters of May 20, 1993, and November 8,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Illinois.
QUANTITY (a) 638 cases (12 bottles per case); (b) 26,900 bottles were
distributed. Firm estimates none remains on the market.
-6- REASON Product does not meet the guidance requirements for a "High
Level Disinfectant." Also the products lack 510(k) and PMA
approval.
_______________
PRODUCT CO2 Industrial Laser, laser machine tool equipment.
Recall #Z-124-4.
CODE Model numbers: S-P 971, S-P 973, S-P 974.
MANUFACTURER Spectra-Physics, Wilmington, Delaware.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan November 29, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 311 units.
REASON Wear of shutter block gear mechanism may cause the laser
shutter clam shell to jam in an open or partially open
position, causing unintended escape of laser radiation and
creating a potential for exposure.
_______________
PRODUCT ROCS Radiation Treatment Planning System: (a) Model 1031;
(b) Model 131. Recall #Z-125/126-4.
CODE Original software release Version 1.2.0 dated 08-17-87 and
subsequent software releases to the original software
identified as Versions: 2.0.1 dated 11-11-87, 2.0.2 dated
01-11-88, 2.0.6 dated 03-17-88, 2.1.6 dated 06-27-88, 2.2.0
dated 11-04-88, 2.3.0 dated 02-24-89, 3.0.0 dated 09-18-89,
3.1.0 dated 09-14-90, 3.2.0 dated 12-12-90, 4.0.0 dated 01-
17-92, 4.0.1 dated 08-11-92, 4.0.2 dated 09-29-92, 4.0.3
dated 10-27-92, 4.0.5 dated 01-11-93, 4.0.7 dated 04-09-93
and Version 4.0.8 dated 05-27-93.
MANUFACTURER Radiation Oncology Computer Systems, Inc., Carlsbad,
California.
RECALLED BY Manufacturer, by letters from 1987 through May 28, 1993.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, Germany, Lebanon, Spain.
QUANTITY 185 user software packages Version 4.0.8.
REASON There have been 19 up-grade versions of the software program
issued since the release of the initial system's software
version on 08/17/87. The frequency and significance of
changes to the radiation and treatment planning system
software suggest an inadequate validation of the software
system.
_______________
PRODUCT CO2 Industrial Laser, laser machine tool equipment.
Recall #Z-133-4.
CODE Model #R-S 974.
MANUFACTURER Rofin-Sinar, Plymouth, Michigan.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan November 20, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
-7- QUANTITY 14 units.
REASON Wear of the shutter block gear mechanism may cause the laser
shutter clam shell to jam in an open or partially open
position, causing unintended escape of laser radiation and
creating a potential for exposure.
_______________
UPDATE Recall #Z-407-3, Ultramark 9 High Definition Imaging
Systems, manufactured by Advanced Technology Laboratories,
Bothell, Washington, which appeared in the April 7, 1993,
Enforcement Report has been extended to correct a possible
M-Mode distance measurement error. The recall is complete.
MEDICAL DEVICE SAFETY ALERTS:
============================================
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PRODUCT Iridium 192 Source for MicroSelectron High Dose Rate (MHDR)
Remote Afterloading System. Safety Alert #N-004-4.
CODE 192IR Sources manufactured since June 1991.
MANUFACTURER Nucletron Corporation, Columbia, Maryland.
ALERTED BY Manufacturer, by letter November 21, 1991, and Technical
Note.
DISTRIBUTION Florida, Argentina, Brazil, Canada, Colombia, Mexico,
Venezuela, West Indies.
QUANTITY 231 Nucletron Planning units and 242 High Dose Rate Units.
REASON The Iridium pellet for the MHDR had been shortened and
therefore had a different center of activity from the
previous design.
SEIZURE:
==================================================================
_______________
PRODUCT Perfluorodecaline 100% (an intraocular fluid used during
surgical treatment of retinal detachments) and accompanying
literature (94-661-732).
CHARGES Adulteration - The article is a class III device for which
no approved premarket approval application is in effect.
Misbranded - Premarket notification or other information has
not been provided as required.
FIRM OPSIA Laboratories, St. Agne, France, being held at the Food
and Drug Administration, Chicago, Illinois.
FILED December 13, 1993; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #93 C 7490;
FDC #66916.
SEIZED December 13, 1993 - goods valued at $63,000.
-8-
END OF ENFORCEMENT REPORT FOR DECEMBER 29, 1993. BLANK PAGES MAY
FOLLOW.
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