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.

October 23, 1996                                      96-43

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I ============
_______________
PRODUCT        Horton's Naturally Smoked Atlantic Salmon,
               packaged in 4 ounce vacuum sealed plastic
               bags.  Recall #F-017-7.
CODE           212136 USE BY 9/04.
MANUFACTURER   Horton's Downeast Foods, Inc., Waterboro,
               Maine.
RECALLED BY    Manufacturer, by telephone on September 17,
               1996.  Firm-initiated recall complete.
DISTRIBUTION   Connecticut, Illinois, Massachusetts, Maine,
               North Carolina, New Hampshire, New York, Ohio,
               Vermont.
QUANTITY       67 pounds were distributed; firm estimates
               none remains on the market.
REASON         Product was contaminated with Listeria
               monocytogenes.


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II ===========
_______________
PRODUCT        Nestle Strawberry Quick Powdered Drink Mix, in
               16 ounce tin boxes.  Recall #F-010-7.
CODE           5093CN.
MANUFACTURER   Nestle Enterprises, Chesterville, Ontario,
               Canada.
RECALLED BY    Nestle Beverage Company, San Francisco,
               California, by letter August 23, 1996.  Firm-
               initiated recall complete.
DISTRIBUTION   Georgia, Pennsylvania, Indiana.
QUANTITY       8,550 cases were distributed; firm estimated
               that little if any product remained on market
               at time of recall initiation.
REASON         Product contained wood fragments.


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III ==========
_______________
PRODUCT        "The Golden Pole" chocolate covered wafer bar,
               12 and 14 ounces, product of Poland.
               Recall #F-011-7.
CODE           BN 86/8094/03.
MANUFACTURER   Cukiernicza Spoldzielnia Pracy, Poland.
RECALLED BY    Eastern Star Distributing Company, Inc.,
               Brooklyn, New York, by letter August 23, 1996. 
               Firm-initiated recall ongoing.
DISTRIBUTION   New York.
QUANTITY       1,285 cartons were distributed; firm estimates
               none remains on the market.
REASON         The specific source of fat and oil (rapeseed)
               is not listed in the ingredient statement. 

_______________
PRODUCT        Best Choice Marshmallow Fudge Cookies, in 12
               ounce cellophane packages.  Recall #F-012-7.
CODE           All product in distribution bearing the
               incorrect nutrient facts panel.
MANUFACTURER   Interbake Foods, Inc., Richmond, Virginia
               (responsible firm). 
RECALLED BY    Associated Wholesale Grocers, Inc., Kansas
               City Kansas, via "satellite" followed by
               letter on September 11, 1996.  Firm-initiated
               recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       Approximately 3,000 12-package cases were
               distributed.
REASON         The nutrition facts panel of the product is
               incorrect.

_______________
PRODUCT        Viking Bakery Muffins:
               (a) Corn Muffins, 14 ounces;
               (b) Bran Muffins, 12 and 14 ounces;
               (c) Blueberry Muffins, 12 ounces.
               Recall #F-013/015-7.

                             -2-CODE           Sell by dates of AUG 28 for product
               manufactured 8/22/96 and AUG 29 for product
               manufactured 8/23/96.
MANUFACTURER   Operative Cake Company, doing business as
               Viking Cake Company, West Hartford,
               Connecticut.
RECALLED BY    Operative Cake Company, Long Island City, New
               York and Automated Bread, Brentwood, Long
               Island, New York, on August 23, 1996. 
               Completed recall resulted from FDA/State of
               Connecticut contract inspection.
DISTRIBUTION   New York. 
QUANTITY       (a) 552 retail units; (b) 264 retail units;
               (c) 96 retail units were distributed; firm
               estimates none remains on the market.
REASON         Products were contaminated with rodent filth
               and were prepared, packaged, and held under
               insanitary conditions.

_______________
PRODUCT        Minute Maid Premium Calcium-Rich Orange Juice,
               in 128 ounce plastic bottles, 96 ounce plastic
               bottles and 64 ounce paper cartons.  
               Recall #F-016-7.
CODE           128 ounce plastic bottles:
               Lot Number:
               Container:  BEST BEFORE OCT 10, A XX:XX
                           BEST BEFORE OCT 16, A XX:XX
                           BEST BEFORE OCT 17, A XX:XX
               Shipping Case:  XX:XX A OCT 10 A40575C
                               XX:XX A OCT 16 A40676C
                               XX:XX A OCT 17 A40649D
               96 ounce plastic bottles:
               Lot Number:
               Container:  BEST BEFORE OCT 15, A XX:XX
                           BEST BEFORE OCT 16, A XX:XX
               Shipping Case:  XX:XX A OCT 15 A40650B
                               XX:XX A OCT 16 A40650B
               64 ounce paper cartons:
               Lot Number:
               Container:  XX:XX OCT 10 A1
                           XX:XX OCT 10 A2
                           XX:XX OCT 15 A1
                           XX:XX OCT 15 A2
                           XX:XX OCT 16 A1
                           XX:XX OCT 16 A2
                           XX:XX OCT 17 A1
                           XX:XX OCT 17 A2

                             -3-               Shipping Case:  XX:XX A OCT 10 A 40445B
                               XX:XX A OCT 10 A 40445C
                               XX:XX A OCT 15 A 40644B
                               XX:XX A OCT 15 A 40644C
                               XX:XX A OCT 16 A 40644B
                               XX:XX A OCT 16 A 40644C
                               XX:XX A OCT 17 A 40766C
               XX:XX represents a 24-hour time.
MANUFACTURER   Coca-Cola Foods, Anaheim, California.
RECALLED BY    Coca-Cola Foods, Houston, Texas, on September
               23, 1996, followed by visit on or before
               September 23, 1996.  Firm-initiated recall
               ongoing.
DISTRIBUTION   California and Arizona.
QUANTITY       24,350 cases were distributed.
REASON         Product has an off-flavor. 


RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS I ============
_______________
UPDATE         Recall #D-254-6, Adrenal Cortex Injection,
               which appeared in the October 16, 1996
               Enforcement Report, should read as follows:
_______________
PRODUCT        All sizes and strengths of ADRENAL CORTEX 
               INJECTION, a Rx injectable drug, labeled as
               distributed by Hallmark Labs, Chicago, IL. 
               Recall #D-254-6.
CODE           All codes (most units are uncoded).
MANUFACTURER   (primary) Ontor Beauty Products, Inc., Opa
               Locka, Florida.
RECALLED BY    Phyne Pharmaceuticals, Inc., Scottsdale,
               Arizona (own-label distributor); by letter
               mailed October 1, 1996.  Firm-initiated;
               ongoing.  See also FDA press release P96-13,
               August 30, 1996.
DISTRIBUTION   Nationwide.
QUANTITY       Undetermined.
REASON         Mycobacterium abscessus contamination of
               unopened vial of Hallmark Labs' labeled
               product distributed by Phyne Pharmaceuticals
               and epidemiological data collected by CDC
               correlating the use of this product with
               Mycobacterium abscesses at the site of
               injection. 


RECALLS AND FIELD CORRECTIONS -- DRUGS -- CLASS III =========
_______________
PRODUCT        Merck's Aquamephyton (Vitamin K) for
               Injection, 10 mg/ml, in 2.5 ml and 5 ml vials,
               indicated for use in the treatment of 

                             -4-               prophylaxis and treatment of hemorrhagic
               disease of the newborn; anticoagulant-induced
               prothrombin deficiency in adults;
               hypoprothrombinemia due to other causes in
               adults.  Recall #D-006-7.
CODE           Lot numbers:  1255A EXP 12/31/96, 0208B EXP
               2/28/97, 0226B EXP 5/31/97.
MANUFACTURER   Merck Manufacturing Division, Division of
               Merck and Company, Inc., West Point,
               Pennsylvania.
RECALLED BY    Manufacturer, by letter on October 10, 1996.
               Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       Firm estimates that 10,000 market packages
               remained on market at time of recall
               initiation.
REASON         Product may be subpotent due to the stopper
               absorbing the active ingredient.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II =========
_______________
PRODUCT        Gemini PC-1 Volumetric Infusion
               Pump/Controller, European 220 Volt Model
               V8.12.  Recall #Z-001-7.
CODE           645 units with individual serial numbers.
MANUFACTURER   IMED Corporation, San Diego, California.
RECALLED BY    Manufacturer, by letter dated June 18, 1996. 
               Firm-initiated recall complete.
DISTRIBUTION   International.
QUANTITY       645 units were distributed.
REASON         The pumps contain a faulty toroid (inductor)
               which may heat up adjacent wires causing an
               electrical short.

_______________
PRODUCT        Max-I-Probe Endodontic Irrigation Syringe:  
               (a) Catalog # MAXE125, 3cc syringe, 25G probe,
               1-2% NaOC1 solution 
               (b) Catalog # MAXE625, 3cc syringe, 25G probe,
               4-6% NaOC1 solution 
               (c) Catalog # MAXE628, 3cc syringe, 28G probe,
               4-6% NaOC1 solution 
               (d) Catalog # MAXE630, 3cc syringe, 30G probe,
               4-6% NaOC1 solution 
               (e) Catalog # MAXE650, trial kit of 2 trays--
               1 tray of 3cc syringes and 1 tray of 10cc
               syringes, with each tray containing 1- 25G,
               -28G and 2-30G probes, with 4-6% NaOC1
               solution 
               (f) Catalog # MAXE825, 3cc syringe, 25G probe,
               2-3% NaOC1 solution 

                             -5-               (g) Catalog # MAXE828, 3cc syringe, 28G probe,
               2-3% NaOC1 solution 
               (h) Catalog # MAXE830, 3cc syringe, 30G probe,
               2-3% NaOC1 solution.  Recall #Z-007/014-7.
CODE           Lot numbers:  (a) 96G13; (b) 96G01;  (c)
               96G03;  (d) 96G05; (e) 96G001; (f) 96G07;  (g)
               96G09; (h) 96G11.
MANUFACTURER   MPL Technologies, Inc., Franklin Park,
               Illinois.
RECALLED BY    Manufacturer, by letter September 9, 1996. 
               Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide and Belgium.
QUANTITY       12,455 syringes were distributed.
REASON         The external finger grip flanges may separate
               from the barrel of the syringe, rendering the
               syringe inoperable.

_______________
PRODUCT        Lifesaver Portable Oxygen Units, Catalog No.
               5000, indicated for delivery of approximate
               low, medium and high concentrations of oxygen. 
               Recall #Z-017-7.
CODE           Serial numbers:
               MHG9411     MHG9412     MHG9502     MHG9505
                 -0006       -0017       -0014       -0002
                 -0009       -0018       -0016       -0006
                 -0011       -0020       -0017       -0065
                 -0053       -0042       -0027       -0068
                 -0054                   -0028       -0075
                 -0055                   -0029       -0076
                 -0057                   -0030       -0077
                 -0059                               -0078
                                                     -0096.
MANUFACTURER   Hudson Respiratory Care, Inc., Temecula,
               California.
RECALLED BY    Manufacturer, by telephone on June 14, 1996,
               followed by letter on June 18 and 19, 1996. 
               Firm-initiated recall ongoing.
DISTRIBUTION   California, Texas, Illinois, Pennsylvania,
               Utah, Missouri, Massachusetts, Canada,
               Honduras.
QUANTITY       42 units were distributed.  
REASON         Device was distributed with a regulator with a
               flow range of 1-8 LPM, instead of the correct
               regulator with a flow range of 2-15 LPM.

_______________
PRODUCT        The ThAIRapy Vest Airway Clearance System,
               used to provide airway clearance therapy. 
               Recall #Z-018-7.
CODE           Serial numbers:  31-00001 through 31-00173.

                             -6-MANUFACTURER   American Biosystems, Inc., St. Paul,
               Minnesota.
RECALLED BY    Manufacturer, by field correcting products
               beginning on or about February 8, 1996.  Firm-
               initiated field correction complete.
DISTRIBUTION   Nationwide.
QUANTITY       173 devices were distributed.
REASON         A shorting in an output transistor could allow
               the device blower to operate at pressures
               higher than specification, resulting in vest
               pressures constricting the thorax and
               impairing inspiration.

_______________
PRODUCT        Low Porosity Woven Vascular Prosthesis,
               Catalog #OLP1206, indicated for replacement or
               bypass procedures in aneurysmal and occlusive
               disease of the abdominal aorta, visceral
               arteries and proximal peripheral arteries
               exclusive of the coronary arteries.  Recall
               #Z-019-7.
CODE           SERIAL NUMBERS                LOT NOS.
               3053001                       94K18
               3053003                       94K18
               3053007                       94K18
               3053008                       94K18
               3053009                       94K18
               3095001                       92K09
               3095002                       92K09
               3095003                       92K09
               3095004                       92K09
               3095005                       92K09
               3095006                       92K09
               3095007                       92K09
               3095008                       92K09
               3095010                       92K09
               3100603                       92J18
               3100604                       92J18
               3100608                       92J18
               3210201                       92K02
               3210203                       92K02
               3210204                       92K02
               3210205                       92K02
               3210206                       92K02
               3210207                       92K02
               3210208                       92K02
               3210209                       92K02
               3285301                       93E21
               3285302                       93E21
               3285304                       93E21
               3285306                       93E21
               3285307                       93E21

                             -7-               3285308                       93E21
               3286301                       93C26
               3286302                       96E17
               3286303                       96E17
               3286304                       93C26
               3286307                       93C26
               3286309                       93C26
               3414701                       93E21
               3414702                       93E21
               3414703                       93E21
               3414706                       93E21
               3414709                       93E21
               3436101                       93F30
               3436404                       93F30
               3436409                       96E17
               3436410                       96A10
               3458903                       96E17
               3458906                       93D30
               3458907                       93D30
               3529702-3529708               95K13
               3550001-3550004               94M16
               3551001-3551010               95M01.
MANUFACTURER   Intervascular Inc., Clearwater, Florida. 
RECALLED BY    Manufacturer, by telephone on August 21, 1996,
               followed by letter.  Firm-initiated recall
               complete.
DISTRIBUTION   Tennessee, New York, Louisiana, Illinois,
               Alabama, Florida, California, Pennsylvania,
               Arizona, Georgia, Texas, New Jersey, Ohio,
               Japan.
QUANTITY       65 unimplanted devices were in commerce at
               time of recall initiation.
REASON         One thread is missing in the involved woven
               vascular prothesis which may potentially
               increase water permeability along the line of
               the pulled thread.

_______________
PRODUCT        Input PS Catheter Introducer Sheath with
               Hydro/pel Coating, used to facilitate placing
               a catheter through the skin into a vein or
               artery:
               (a) 5F
               1000511       5F 11 CM Input 2 (Freeway)
               050011        5F 11 cm Input Introducer Intl.
               055011        5F 11 cm Input Introducer
               063311        5F 11 cm Input II Introducer
               553311        5F 11 cm Input Introducer Intl
               853311        5F 11 cm Input Introducer
               FC4631951     5F Grey Input II Assembly

                             -8-               (b) 6F
               1000611       6F 11 cm Input 2 (Freeway)
               060011        6F 11 cm Input Introducer Intl.
               063312        6F 11 cm Input II Introducer
               065011        6F 11 cm Input Introducers
               563311        6F 11 cm Input Introducer Intl.
               863311        6F 11 cm Input Introducer
               1000623       6F 23 cm Input 2 (Freeway)
               060023        6F 23 cm Input Introducer kit.
               063317        6F 23 cm Input II Introducer kit
               FC4631952     6F Green Input II Assembly
               (c) 7F
               1000711       7F 11 cm Input 2 (Freeway)
               063313        7F ll cm Input II Introducer
               070011        7F 11 cm Input Introducer Intl.
               075011        7F 11 cm Input Introducer
               573311        7F 11 cm Input Introducer Intl.
               873311        7F 11 cm Input Introducer
               1000723       7F 23 cm Input 2 (Freeway)
               063318        7F 23 cm Input 2 Introd.  Kit
               070023        7F 23 cm Input Introducer Kit
               FC4631953     7F Orange Input II Assembly
               (d) 8F
               080011        8F 11 cm Input Introducer Intl.
               085011        8F 11 cm Input Introducers
               080023        8F 23 cm Input 2 (Freeway)
               583311        8F 11 cm Input Introducers Intl.
               883311        8F 11 cm Input Introducer
               063314        8F 11 cm Input II Introducer
               063319        8F 11 cm Input II Introducer kit
               1000823       8F 23 cm Input 2 (Freeway)
               1000811       8F 11 cm Input 2 (Freeway)
               FC4631954     8F Blue Input II Assembly
               (e) 9F
               063320        9F 23 cm Input 2 Introducer Kit
               090023        9F 23 cm Input Introducer Kit
               063315        9F 11 cm Input II Introducer
               090011        9F 11 cm Input Introducer Intl.
               095011        9F 11 cm Input Introducers
               593311        9F 11 cm Input Introducer Intl.
               893311        9F 11 cm Input Introducer
               FC4631955     9F Grey Input II Assembly.
               Recall #Z-020-024-7.
CODE           All lot numbers of product produced since May
               1995.
MANUFACTURER   C.R. Bard Irl., Ballybrit, Galway.
RECALLED BY    USCI Manufacturing Facility, Billerica,
               Massachusetts, by letter on August 13, 1996,
               and by telephone and interoffice mail.  Firm-
               initiated recall ongoing.
DISTRIBUTION   Nationwide and international.

                             -9-QUANTITY       Approximately 980,539 units were distributed.
REASON         Introducer hub is separating at or near the
               weld site of the upper and lower hub body
               parts.  Failure could result in significant
               blood loss or air embolism.

_______________
PRODUCT        Microvision-C Radiographic Film, used for
               mammography.  Recall #Z-027/028-7.
CODE           Product is identified by Type, Emulsion #, Run
               #, and Cut#:
               GROUP A
               TYPE   EMULSION  RUN   CUT     SIZE   STOCK#
                597    6042     0038  ALL     18X24  529567
                                0050  ALL     18X24  529567
                                0054  ALL     18X24  529567
                597    6052     0034  ALL     18X24  529567
                                0035  ALL     18X24  529567
                                0075  ALL     18X24  529567
                597    6062     0034  ALL     24X30  52963A
                                0035  ALL     18X24  529567
                                0035  01-07   24X30  52963A
                                      21-26
                                0036  03-07   18X24  529567
                                0036  01,02   24X30  52963A
                                0037  ALL     18X24  529567
                                0048  ALL     24X30  52963A
                                0069  03-07   18X24  529567
                                0069  01,02   24X30  52963A
                597   6072      0078  ALL     18X24  529567
               (b) GROUP B
               TYPE   EMULSION  RUN   CUT     SIZE   STOCK#
                597   6052      0036  ALL     18X24  529567
                597   6062      0027  03-07   18X24  529567
                                0027  01,02   24X30  52963A
                                0032  ALL     18X24  529567
                                0051  ALL     24X30  52963A
                                0059  ALL     18X24  529567
                                0068  03-07   18X24  529567
                                0068  01,02   24X30  52963A
                                0070  ALL     24X30  52963A
                                0071  03-07   18X24  529567
                                0071  01,02   24X30  52063A
                                0072  03-07   18X24  529567
                                      21-26
                                0072  01,02   24X30  52963A
                                0073  03,07   18X24  529567
                                0073  01,02   24X30  52963A
                                0076  ALL     24X30  52963A
                                0077  03-07   18X24  529567
                                0077  01,02   24X30  52963A
                597   6072      0046  ALL     24X30  52963A
                                0049  ALL     24X30  52963A.
                            -10-MANUFACTURER   Sterling Diagnostic Imaging, Inc., Brevard,
               North Carolina.
RECALLED BY    Sterling Diagnostic Imaging, Inc., Newark,
               Delaware, by letter dated August 30, 1996. 
               Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide, Mexico, Brazil, Latin America.
QUANTITY       Firm estimated that 19,388 boxes of film
               remained on market at time of recall
               initiation.
REASON         The devices have demonstrated uncharacteristic
               aging, that is below working limits for speed
               for this product, which may result in the
               mis-diagnosis in mammography readings.

_______________
UPDATE         Invacare Oxygen Concentrators Mobilaire III/V,
               and Invacare III/V Oyxgentrators, Recall #Z-
               1216/1219-6, which appeared in the September
               25, 1996 Enforcement Report, should read as
               follows:
_______________
PRODUCT        (a) Mobilaire III Oxygen Concentrator, Model
               No. IRC301;
               (b) Mobilaire V Oxygen Concentrator, Model No.
               IRC501; (c) Invacare V Oxygen Concentrator,
               Model No. IRC 50102, with optional Oxygen,
               Purity Indicator.  Recall #Z-1216/1218-6.
CODE           Serial Numbers 96B46257-94B46706, 96B99247-
               96B99265 and 96B50320-96B50916 which
               corresponds to all of the involved devices
               manufactured from 1/30/96 to 2/27/96.
MANUFACTURER   Invacare Corporation, Sanford, Florida.
RECALLED BY    Manufacturer, by telephone on March 8, 1996,
               and October 4, 1996.  Firm-initiated recall
               ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       193 units were distributed.
REASON         Kinked oxygen transfer hoses in the units
               caused by defective exterior foam insulation
               may affect the flow of oxygen, and therefore,
               affect the concentration of oxygen the patient
               receives.

                            -11-

END OF ENFORCEMENT REPORT FOR OCTOBER 23, 1996.  BLANK PAGES MAY FOLLOW.

                                   ####

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