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
02/07/1996
ENFORCEMENT REPORT FOR 02/07/96
February 7, 1996 96-06
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Hearth Oven and President Choice brand
Confetti Cookies, in 10 ounce (12 count) and
31 ounce (36 count) packages, and 15 ounce
mini cookie in plastic tubs. Recall #F-280-6.
CODE Pull date of November 20 or earlier.
MANUFACTURER Hearth Oven Bakery, Clawson, Michigan.
RECALLED BY Great Atlantic and Pacific Tea Company,
Montvale, New Jersey, by memorandum November
6, 1995. Firm-initiated field correction
(relabeling) complete.
DISTRIBUTION Michigan.
QUANTITY Undetermined.
REASON Product contained undeclared eggs.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Carrot and Coffee Cake:
(a) Chimes brand Carrot Cake, in 11 ounce
packages;
(b) Chimes brand Carrot Cake, in 3 ounce
packages;
(c) Lady Linda brand Coffee Cake, in 4 ounce
packages. Recall #F-272/274-6.
CODE Sell by Dates: (a) Jan 22; (b) Jan 25;
(c) Jan 23.
MANUFACTURER Chimes Bakery, Inc., West Hartford,
Connecticut.
RECALLED BY Operative Cake Company, Long Island City, New
York, by letter September 15, 1995. Firm-
initiated recall complete.
DISTRIBUTION New York.
QUANTITY Firm estimates none remains on the market.
REASON Products contain undeclared FD&C Yellow No. 5,
No. 6. and Red No. 40.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Gerber Graduates Apple Juice for
toddlers/children in 46 ounce clear plastic
bottles. Recall #F-260-6.
CODE Lot #2811 28JUL96 on lid.
MANUFACTURER Ameripec, Inc., Buena Park, California.
RECALLED BY Gerber Products Company, Fremont, Michigan, by
E-Mail letter on September 18, 1995. Firm-
initiated recall complete.
DISTRIBUTION Arkansas, North Carolina.
QUANTITY Approximately 2,951 cases (6 bottles per case)
were distributed.
REASON Product is unfit for food due to the vinegary
and sour taste.
_______________
PRODUCT Fruity Cider Vinegar, in 32.1 fluid ounce
glass jars (shaped like a rolling pin) on a
wooden display rack. Recall #F-267-6.
CODE All product.
MANUFACTURER Freeport Forwarding, doing business as Au
Printemps Gourmet, Champlain, New York.
RECALLED BY AU Printemps Gourmet, Prevost (Quebec),
Canada, by letter on December 7, 1995. Firm-
initiated recall complete.
DISTRIBUTION Virginia, Florida, Maryland.
QUANTITY Approximately 2,040 bottles were distributed.
REASON Product is contained in short weight
containers and is adulterated due to insect
filth contamination.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT L-Glutamine, bulk powder, in 1 kg boxes, an
amino acid used for further manufacturing in
oral and parenteral solutions.
Recall #D-083-6.
CODE Ajinomoto lot #R014C007; Coram Healthcare's
lot #810007LM.
-2- MANUFACTURER Ajinomoto Company, Kawasaki, Japan.
RECALLED BY Ajinomoto USA, Inc., Raleigh, North Carolina,
by telephone on January 16, 1996, and by
letter on January 19, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Georgia, Minnesota, Massachusetts, New Jersey,
Indiana, Illinois, New York, Pennsylvania,
Michigan, Texas.
QUANTITY 227 kgs were distributed.
REASON Pyrogenic, not suitable for parenteral use.
_______________
PRODUCT Levothyroxine Sodium Tablets, USP, 0.025 mg,
in bottles of 100 and 1000, used for the
treatment of patients with hypothyroidism.
Recall #D-084-6.
CODE Lot numbers: MLT0223A EXP 7/96, MLT0321A EXP
9/96, MLT0442A EXP9/96, MLT0441E EXP 9/96,
MLT4441A EXP 4/97, MLT4442A EXP 4/97, MKT2131A
EXP 3/96, MKT2132A EXP 3/96.
MANUFACTURER MOVA Pharmaceutical Corporation, Caguas,
Puerto Rico.
RECALLED BY Duramed Pharmaceuticals, Inc., Cincinnati,
Ohio, by letter January 19, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Potency not assured through expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-171/172-6.
CODE Unit #04V12191.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
RECALLED BY Manufacturer, by telephone on March 21, 1994,
and by letter dated March 24, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a
donor whose spouse was diagnosed as a chronic
carrier of hepatitis B, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Night Vision Monocular, Russian made lasers.
Recall #Z-361/362-6.
CODE (a) Night Vision Monocular Model 2.6 x 30 TNS;
(b) Night Vision Monocular Model 5 x 52 TNS.
-3- MANUFACTURER International Sourcing, Inc., Fort Wayne,
Indiana.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan December 1995. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 12 units.
REASON The laser product failed to comply with the
following provisions of the Federal laser
product performance standard, 21 CFR 1010.2
Certification; 1010.3 Identification;
1040.10((f)(3) remote interlock connector;
(f)(4) key control; (f)(5)(ii) emission
indicator; (f)(6) beam attenuator; (g)(2)(iii)
warning logotype; (g)(5) aperture label and
(h)(1)(iii) user information)).
_______________
PRODUCT Lumadex-FSI Fetal Lung Maturity Test Kit, Part
#667790, used to measure the foam stability
index of amniotic fluid, an indicator of fetal
lung maturity in high-risk pregnancies.
Recall #Z-371-6.
CODE Lot #M506095.
MANUFACTURER Beckman Instruments, Inc., Carlsbad,
California.
RECALLED BY Beckman Instruments, Inc., Brea, California,
by telephone from August 25, 1995 through
October 4, 1995. Firm-initiated recall
complete.
DISTRIBUTION Arkansas, California, Colorado, Indiana,
Kentucky, Massachusetts, Michigan, Missouri,
North Carolina, Nevada, South Dakota, Texas,
West Virginia.
QUANTITY 36 kits were distributed; firm estimates none
remains on the market.
REASON Precipitate formation in the reaction wells,
which could result in misreading the foam
stability index, which may cause an incorrect
determination of fetal lung maturity.
_______________
PRODUCT Puritan Bennett C2800 Portable Ventilator,
indicated for the delivery of gas to patients
on artificial respiration in home and subacute
care environments. Recall #Z-381-6.
CODE Units with unique, unsequential serial
numbers.
MANUFACTURER Nellcor Puritan Bennett, Carlsbad, California.
RECALLED BY Manufacturer, by letter November 21, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Canada, England.
-4- QUANTITY 88 units.
REASON An insecure wire connection from the internal
battery to the logic circuit of the ventilator
may cause an open circuit, resulting in the
ventilator delivering tidal volumes of 2.5 -
3.0 liters at 25 - 30 breaths per minute,
regardless of set parameters, and without
audio or visual alarm.
_______________
PRODUCT Polydoros X-Ray Systems, a universal
application in General x-ray diagnosis (multi-
purpose and cardiology). Recall #Z-389/393-6.
CODE Models: Polydoros 80, 80A, 100, 100A, and C.
MANUFACTURERSiemens Aktiengesellschaft, Erlangen, Germany.
RECALLED BY Siemens Medical Systems, Inc., Iselin, New
Jersey. FDA approved the firm's corrective
action plan May 25, 1994. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 4,162 units.
REASON The Polydoros x-ray control may lock up during
pulsed fluoroscopy. During this lock-up
condition, the fluoroscopy foot switch would
not respond; however, the x-ray control would
incorrectly indicate that radiation is present
resulting in the x-ray unit to be noncompliant
with 21 CFR 1020.32(c).
_______________
UPDATE Recall #Z-267/319-6, Horizon I.V.
Administration Sets used with the Horizon
Modular Infusion Systems, which appeared in
the January 10, 1996 Enforcement Report listed
the code as all lots. This should be changed
to the following:
The 141 lots under recall are lot numbered as
follows. F5D***, F5E***, F5H***, F5J***,
F5K***, F5L053, F5L054, F5L055, F5L079,
F5L080, F5L133, F5L136, F5L137, F5L138,
F5L140, F5L141, F5L142, F5L159, F5L215,
F5L217, F5L218, F5L219, F5L220, F5L224,
F5L225, F5L231. The lot number is interpreted
as follows: F = Puerto Rico; 5 = 1995; Alpha
Character = month e.g. D = April, E = May
etc.; last 3 digits are sequential production
without regard to product produced.
-5- MEDICAL DEVICE SAFETY ALERTS: ==============================
_______________
PRODUCT Companion Oxygen Concentrators with OCI, used
to provide a supplemental supply of oxygen:
(a) Model 492A; (b) Model 590.
Safety Alert #N-004/005-6.
CODE None.
MANUFACTURER Puritan Bennett Corporation, St. Charles,
Missouri.
ALERTED BY Manufacturer, by letter May 19, 1995.
DISTRIBUTION Nationwide.
QUANTITY Approximately 112,600 units were distributed.
REASON All consignees were informed of an electrical
fire hazard involving loose electrical outlets
and to check the outlet into which the oxygen
concentrator is being plugged to assure it is
not loose fitting.
-6-
END OF ENFORCEMENT REPORT FOR FEBRUARY 7, 1996. BLANK PAGES MAY
FOLLOW.
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