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
07/08/1992
RECALLS AND FIELD CORRECTIONS: July 8, 1992
FOODS - CLASS II
92-28
PRODUCT UCD-2 Amino Acid Mixture with vitamins and minerals, net weight
17-1/2 ounces, in powder form in a metal can. Recall #F-365-2.
CODE Lot number 4KM30 USE BY: 1 FEB 93
MANUFACTURER Milupa AG, Federal Republic of Germany.
RECALLED BY Bristol-Myers Squibb Company, Mead Johnson Nutritional Group,
Evansville, Indiana, by telephone May 11, 1992, followed by
letters between May 11 and 15, 1992. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 51 cases (2 cans per case) and 1 can were distributed.
REASON Some cans labeled as MSUD-2 instead of UCD-2.
PRODUCT Acme brand Canned Sliced Mushrooms, in 4 ounce cans.
Recall #F-366-2.
CODE Three line can code: CMS/SK/1518.
MANUFACTURER S.K. Foods, Inc., Bangkok, Thailand.
RECALLED BY Acme Markets, Inc., Malvern, Pennsylvania, by telephone May 4,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, New Jersey, Delaware, New York.
QUANTITY 3,000 cases (24 cans per case) were distributed.
REASON Product is contaminated with Staphylococcus enterotoxin.
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
PRODUCT Chef Romeo's Hand Rolled Spinach Roll with Cheese.
Recall #F-367-2.
CODE All date codes.
MANUFACTURER Matlaw's Food Products, Inc., West Haven, Connecticut.
RECALLED BY Manufacturer, by telephone June 1, 1992, followed by letter
June 4, 1992. Firm-initiated recall ongoing.
DISTRIBUTION New York, New Jersey.
QUANTITY 1,003 units were distributed.
REASON Product makes no preservative claims on the label but contains
sorbic acid, a preservative.
PRODUCT Various Chiquita brand 100% fruit juice blends, in 8.45 fluid
ounce paper cartons:
(a) Calypso Breeze; (b) Orange Banana; (c) Caribbean Splash.
Recall #F-368/370-2.
CODE All lots.
MANUFACTURER Guida Siebert Dairy, New Britain, Connecticut.
RECALLED BY Chiquita Brands, Inc., Cincinnati, Ohio, by telephone May 18-19,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Maryland, Pennsylvania, Rhode Island, New Jersey, Connecticut,
New York, Virginia, Delaware, Florida, Maine, Massachusetts,
New Hampshire.
QUANTITY 40,000 cases (24 units per case) were distributed; firm
estimates 18,000 cases remain on the market.
REASON Product is contaminated with yeast.
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
PRODUCT Clindamycin Phosphate Injection, USP, 150 mg/ml, in 4 ml single
dose vials, a Rx antibiotic. Recall #D-407-2.
CODE Lot #110431 EXP 10/92.
MANUFACTURER Lyphomed, Division of Fujisawa USA, Inc., Melrose Park,
Illinois.
RECALLED BY Manufacturer, by letter June 17, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Ecuador.
QUANTITY 21,000 vials were distributed; firm estimates 10,000 vials
remain on the market.
REASON Potency not assured through expiration date.
PRODUCT Milk of Magnesia, USP, 1 pint containers. Recall #D-408-2.
CODE Lot #2A6322.
MANUFACTURER Paddock Laboratories, Inc., Minneapolis, Minnesota.
RECALLED BY Manufacturer, by letter June 29, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
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QUANTITY 3,473 pint bottles were distributed; firm estimates that 50
percent of the product remains on the market.
REASON One or more bottles of Aluminum Acetate Solution was mislabeled
as Milk of Magnesia.
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
PRODUCT Parke-Davis brand Easprin Tablets, aspirin delayed-released
tablets, USP, 15 gr. Recall #D-406-2.
CODE Lot numbers and EXP dates: 05850VA 6/91, 04970VA 9/92, 057D0VA
1/93, 05770VA 9/92, 04111VA 1/93, 01400VA 11/92, 01500VA 11/92,
11090VA 10/92, 09011VA 2/93, 06421VA 2/93, 11190VA 10/92.
MANUFACTURER Warner Lambert, Inc., Vega Baja, Puerto Rico.
RECALLED BY Parke-Davis Division of Warner Lambert Company, Morris Plains,
New Jersey, by letter May 15, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 99,420 bottles were distributed; firm estimates none remains on
the market.
REASON Product may not meet drug release specifications through
expiration date.
PRODUCT Chlorpropamide, 250 mg, in 100, 500 and 1,000 tablet bottles, a
Rx anti-diabetic, under the following labels: Sidmak, Aligen
Independent Laboratories, H.L. Moore Drug Exchange, United
Research Laboratories, Harber, Best Generics, Par-Med, Martec,
Genetco, Major, Rugby. Recall #D-405-2.
CODE Lot numbers and EXP dates:
0511113 EXP 7/93 (Sidmak), 0511114 EXP 7/93 (Sidmak), 0511115
EXP 7/93 (Harber, Best Generics, Par-Med, Sidmak), 0511116 EXP
7/93 (Rugby, Martec), 0511117 EXP 7/93 (Rugby), 0511118 EXP
7/93 (Sidmak), 0511120 EXP 7/93 (Major, Aligen), 0511121 EXP
7/93 (Rugby, URL, Sidmak), 0511122 EXP 7/93 (H.L. Moore, Major,
Martec, Par-Med, Best Generics, Rugby,) 0511123 EXP 7/93 (URL,
Rugby), 0511124 EXP 7/93 (Genetco, Martec, URL, Sidmak),
0812092 EXP 11/93 (Aligen, Harber, Sidmak), 0812094 EXP 11/93
Sidmak), 0701298 EXP 8/92 (Rugby), 0701299 EXP 8/92 (Rugby).
MANUFACTURER Sidmak Laboratories, East Hanover, New Jersey.
RECALLED BY Manufacturer, by letter May 21, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 10,943 1,000-tablet bottles, 566 500-tablet bottles and 33,904
100-tablet bottles were distributed; firm estimates 25% to 40%
remains on the market.
REASON Product may not meet dissolution specifications through
expiration date.
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UPDATE Ibuprofen Tablets, 200 mg, in bottles of 100, Recall #D-122-2,
which appeared in the December 26, 1991 Enforcement Report has
been extended to include the following lot numbers:
#A01191, #B00591, #B00691, #B00791, #E00591 and #M00690.
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
PRODUCT Dentrol Liquid Denture Adhesive, 1.5 fluid ounces.
Recall #Z-968-1.
CODE Lot #10019.
MANUFACTURER Block Drug Company, Inc., Memphis, Tennessee.
RECALLED BY Block Drug Company, Inc., Jersey City, New Jersey, by telephone
July 31, 1991. Firm-initiated recall complete.
DISTRIBUTION Arizona, California, Colorado, Nevada, Utah.
QUANTITY 480 dozen were distributed.
REASON Product was contaminated with Pseudomonas aeruginosa.
PRODUCT Nezhat Suction/Irrigation Probe, a reusable device used in
laparoscopic surgery. Recall #Z-763-2.
CODE All units shipped prior to 11/8/91.
MANUFACTURER Cabot Medical Corporation, Langhorne, Pennsylvania.
RECALLED BY Manufacturer, by letter January 16,1991. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY All units were corrected.
REASON The sterility status of the KLI Lubricant Grease used to
prevent sticking and leaking of the trumpet valves in the probe
was not documented.
PRODUCT: AMS 700 pump used with Ultrex Penile Prostheses. The Ultrex
and the Ultrex Plus Penile Prostheses are the same devices
except that the Ultrex Plus is pre-filled with saline solution
and comes with the pump:
(a) AMS 700 Ultrex Plus Penile Prostheses, part numbers
72401460, 72401461, 72401463, 72401464, 72401466, 72401467,
72401469;
(b) AMS 700 Inflate/Deflate Pumps (for penile prostheses), part
number 72400151. Recall #Z-816/817-2.
CODE Lot numbers: (a) 1236P, 1842P, 1844P, 1845P, 1846P, 1848P,
1850P, 1853P, 1856P, 2275P, 2276P, 2277P, 2280P, 2281P, 2290P,
2293P, 2840P, 3400P;
(b) 2023P 2024P 2025P 2026P 2027P 2028P 2029P
2030P 2031P 2032P 2033P 2034P 2035P 2036P
2037P 2038P 2039P 2040P 2041P 2042P 4034R
4035R 4036R 4037R.
MANUFACTURER American Medical Systems, Pfizer Hospital Products Group,
Minnetonka, Minnesota.
RECALLED BY Manufacturer, by telephone May 6 or 7, 1992, followed by letter
May 8, 1992. Firm-initiated recall ongoing.
-4-
DISTRIBUTION Nationwide, Australia, Belgium, Canada, England, Germany,
Italy, Spain.
QUANTITY 212 units were distributed.
REASON A stainless steel component of the pump may be showing evidence
of corrosion (shown as a discoloration of the device fluid) in
some of the devices which could affect the functionality of the
pump over time.
PRODUCT Ames brand Glucometer M+ Diabetes Care System Kit.
Recall #Z-818-2.
CODE Catalog #NDC-0193-54920-01. All lots made between 3/91 and
12/2/91 with serial numbers between 1000100 and 1005541.
MANUFACTURER Miles, Inc., Diagnostic Division, Mishawaka, Indiana.
RECALLED BY Manufacturer, by letter December 2,1991. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 3,000 units were distributed.
REASON Readings on the meter were excessive due to leakage of
incandescent light into the meter.
PRODUCT Continuous non-invasive blood pressure monitoring devices which
measure and display patient blood pressure parameters:
(a) Colin CBM-3000 Continuous Arterial Tonometer;
(b) Nellcor N-Cat Continuous Non-Invasive Blood Pressure
Monitoring Device. Recall #Z-833/834-2.
CODE Lot numbers:
(a) Lot numbers Serial numbers
582 330041-330100, inclusive
(b) None SAM1011, SAM1013, SAM1014
None A000013, A000102, A000103,
A000204-A000206,
A000210
002 AA100001-AA100100
358 AA100101-AA100300
359 AA100301-AA100600
360 AA100601-AA100770
593 AA100771-AA100920
594 AA100921-AA100990
631 AA100991-AA101064
434 UA100001-UA100030
598 UA100031-UA100055
614 FA100001-FA100025
MANUFACTURER Colin Electronics, Komaki City Aichi-Prep, Japan.
RECALLED BY Colin Medical Instruments Corporation, San Antonio, Texas, by
letter March 17, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION California, Connecticut, Massachusetts, Minnesota, North
Carolina, Texas, Canada.
QUANTITY (a) 27 units; (b) 1,085 units were distributed.
REASON Reports of erroneous readings of tonometric blood pressure
waveforms during the use of both devices.
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PRODUCT Omniflex Microstructured Hip Stem #13 Stem 40 mm nk Large
Distal Stem Taper. Recall #Z-835-2.
CODE Catalog #1008-1340, sterile lot #8911P, case code: FA150XA
(also identified as FA150X by firm).
MANUFACTURER Ostenoics Corporation, Allendale, New Jersey.
RECALLED BY Manufacturer, by letter April 23, 1992. Firm-initiated recall
complete.
DISTRIBUTION California, North Carolina, Alabama, Minnesota, Indiana,
Wisconsin, Texas, Nebraska.
QUANTITY 11 units were distributed; firm estimates none remains on the
market.
REASON Product was labeled with an incorrect size on the inner
labeling.
SEIZURES:
PRODUCT "Suncorn Pure Corn Oil 100% Natural" (91-637-523/5).
CHARGE Adulterated - Soybean oil has been substituted in part for
corn oil.
Misbranded - The products' labeling is false and misleading
because: it represents the products to be pure corn oil; it
contains the statement "No Cholesterol," suggesting that the
products differ from other corn oils, when, in fact, all
vegetable oils are free of cholesterol; and the nutrition
information and net quantity of contents statements on the
labeling fail to conform to the requirements set forth by
regulation.
FIRM Intermares Group, Inc., Catano, Puerto Rico.
FILED May 5, 1992 - U.S. District Court for the District of Puerto
Rico; Civil #Civil 92-1673(JP); FDC #66407.
SEIZED June 30, 1992 - goods valued at $45,000.
PRODUCT Hysterosalpingography (H/S) catheter sets and procedure
trays (92-588-758).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the manufacture, processing, packing, and
holding of the devices are not in conformity with the
current good manufacturing practice regulations.
FIRM Ackrad Laboratories, Inc., Cranford, New Jersey.
FILED June 4, 1992 - U.S. District Court for the District
of New Jersey; Civil #92-2349(HAA); FDC #66408.
SEIZED June 19, 1992 - goods valued at $167,300.
PRODUCT Mela Folia tea tree oil products and accompanying brochures
(92-623-410).
CHARGE New drug - The products are unapproved new drugs.
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Misbranded - The products' labeling is false and misleading
because it represents and suggests that the articles are safe
and effective for various diseases, which representations and
suggestions are false. In addition, the products' labeling
lacks adequate directions for use whereby the products may be
used safely and effectively for their intended purposes.
FIRM AAAA Self Storage, Chesapeake, Virginia.
FILED May 14, 1992 - U.S. District Court for the Eastern District
of Virginia; Civil #2:92CV372; FDC #66392.
SEIZED May 20, 1992 - goods valued at approximately $46,528, plus
brochures.
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END OF ENFORCEMENT FOR JULY 8, 1992. BLANK PAGES MAY FOLLOW.
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