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
06/26/1996

ENFORCEMENT REPORT FOR 06/26/1996

June 26, 1996 96-26

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Hershey Sweet Escapes Chocolate Toffee Crisp
Bars. Recall #F-605-6.
CODE 37M08520/6J.
MANUFACTURER Hershey Chocolate USA, Hershey, Pennsylvania.
RECALLED BY Manufacturer, by issuing press release on May
11, 1996. A notification dated May 13, 1996
was issued by the Food Allergy Network. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,250 cases (each case contains 12 pouches,
each pouch contains 9 bars) were distributed.
REASON Undeclared peanuts. Some pouches of the
Chocolate Toffee Crisp Bars contain both
Chocolate Toffee Crisp Bars and Caramel and
Peanut Butter Crispy Bars.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Sunny Delight Citrus Beverages in 8 fluid
ounce and 16 fluid ounce sizes, various
flavors, and Hawaiian Punch Chillers in 8
fluid ounce size, regular and no sugar added: 1. Sunny Delight Citrus Beverage, Florida
Citrus Punch Flavor
2. Sunny Delight Citrus Beverage, California
Style Citrus Punch Flavor
3. Sunny Delight Citrus Beverage, Lite
Florida Citrus Punch Flavor
4. Sunny Delight Citrus Beverage, Mango
Flavor
5. Sunny Delight Citrus Beverage, Passion
Fruit Flavor
6. Sunny Delight Citrus Beverage, Strawberry
Flavor
7. Sunny Delight Citrus Beverage, Grape
Flavor
8. Sunny Delight Citrus Beverage, Tropical
Fruit Punch Flavor
9. Sunny Delight Citrus Beverage, Kiwi Flavor
10. Sunny Delight Citrus Beverage, Lemon Lime
Flavor
11. Sunny Delight Citrus Beverage, Raspberry
Flavor
12. Hawaiian Punch Chillers, regular
13. Hawaiian Punch Chillers, no sugar added.
Recall #F-584/596-6.
CODE APR30K through AUG22K on bottles.
MANUFACTURER Sundor Brands, Inc., Dayton, New Jersey.
RECALLED BY The Procter & Gamble Company, Cincinnati,
Ohio, by press release on May 23, 1996, and by
letter mailed on May 29, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Connecticut, Delaware, Maine, Maryland,
Massachusetts, New Hampshire, New Jersey, New
York, Pennsylvania, Rhode Island, Vermont,
Virginia, Washington, D.C., Indiana, Florida,
Puerto Rico, Bermuda, Germany.
QUANTITY 43,440,000 bottles were produced; firm
estimates that approximately 50 bottles may be
affected.
REASON Some bottles contain a thin plastic film, 1 to
4 inches in size.

_______________
PRODUCT Freezer Bowls for Maverick Ice Cream Shoppe
Ice Cream Makers. Recall #F-600-6.
CODE Model # MIC-001x with manufacture dates of
10/95 or 11/95 and shipped prior to 12/31/95.
MANUFACTURER Norse Hydro Group, China.
RECALLED BY Maverick Industries, Inc., Edison, New Jersey,
by letter mailed on June 7, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Texas, Oregon,
California.

-2-QUANTITY 6,932 units were distributed.
REASON Some freezer bowls are defective and can leak
freezer bowl liquid into the ice cream.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Rosa brand Tomato Paste in 6 ounce and 12
ounce cans. Recall #F-597-6.
CODE Lot Numbers: 6 ounce cans
AG217/H3FT AG219/02FT AG219/03FT
AG219/P2FT AG219/P3FT AG223/L3FT
AG224/G2FT AG225/J2FT AG225/J3FT
AG225/L2FT AG225/L3FT AG230/F3FT
AH108/C2FT AH108/E2FT AH108/H2FT
AH108/H3FT AH108/N2FT AH108/N3FT
AH108/P2FT AH108/P3FT AH108/S2FT
AH108/Y2FT AH108/Y3FT AH109/E2FT
AH109/E3FT AH109/G2FT AH109/G3FT
AH109/N2FT AH109/U2FT AH109/U3FT
AH109/W2FT AH109/W3FT AH110/S2FT
AH110/S3FT AH204/B2FT AH215/T2FT
AH215/U2FT AJ203/O2FT AJ203/O3FT
AJ205/A2FT AJ205/A3FT
12 ounce cans:
4PRCH/2731E 4PICH/2729U WG214M1FT
WG215M2FT WG215P1FT WG215P2FT
WG215R1FT WG215R2FT WG221X1FT
WG222E1FT WG222E2FT.
(there were 6 cans with no lot number and 343
rusted cans with no lot number).
MANUFACTURER Nestle Food Company, Woodland, California, and
Modesto, California.
RECALLED BY Rosa Food Products Company, Inc.,
Philadelphia, Pennsylvania, by letter dated
March 12, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Pennsylvania, Delaware, New Jersey, New York.
QUANTITY 4,220 cans of the 6 ounce cans and 5,563 cans
of the 12 ounce cans were distributed.
REASON The product is unfit for food due to exploding
cans.

_______________
PRODUCT Chocolate candies: (a) Assorted Milk
Chocolates containing chocolate covered
creams, nuts and cherries, in 5 ounce and 1
pound cardboard boxes; (b) All Nut Assortment
containing chocolate covered peanuts, cashews,
and walnuts, in 5 ounce cardboard boxes.
Recall #F-598/599-6.
CODE None. All product shipped prior to 2/28/96.

-3-MANUFACTURER Wagner Candy Company, Finleyville,
Pennsylvania.
RECALLED BY Manufacturer, by visit beginning February 28,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY (a) 100 5-ounce boxes and 24 1-pound boxes;
(b) 100 5-ounce boxes were distributed.
REASON The labeling lists only "nuts" but does not
specify what kind of nut is in the product.

_______________
PRODUCT Hi-C Fruit Juice Drinks: (a) Hi-C cherry
fruit juice drink in 8.45 fluid ounce
containers; (b) Hi-C orange fruit juice drink
in 8.45 fluid ounce containers; (c) Hi-C grape
fruit juice drink in 8.45 fluid ounce
containers; (d) Hi-C variety packs containing
orange, grape, and fruit punch drinks in 8.45
fluid ounce containers. Recall #F-601/604-6.
CODE (a) Package Code - FEB2197AG
Case Code - FEB 20 97 A37301A
FEB 21 97 A37301B
(b) Package Codes - DEC2296AC, DEC2296AD,
DEC2396AC,DEC2396AD
Case Codes - DEC 22 96 A37299B,
DEC 23 96 A37299C
(c) Package Codes - FEB2397AC, FEB2397AD,
FEB2497AC, FEB2497AD
Case Codes - FEB 24 97 A37302E
(27 per case) and
FEB 23 97 A37302D
FEB 24 97 A37302E
(30 per case)
(d) Case Codes - A37310D (24 per case)
A37406D, A37430A, A3756C
(27 per case).
MANUFACTURER Coca-Cola Foods, Anaheim, California.
RECALLED BY Coca-Cola Foods, Houston, Texas, by visits
beginning May 10, 1996. Firm-initiated recall
complete.
DISTRIBUTION Arizona, California, Hawaii.
QUANTITY 15,107 cases were distributed.
REASON Yeast contamination.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Aristocort Forte Suspension, 40 mg/ml, 5 ml
per vial, Rx corticosteroid. Recall #D-162-6.
CODE Lot #4450-31-6088A, Control #397-807.
MANUFACTURER Lederle Parenterals, Inc., Carolina, Puerto
Rico.

-4-RECALLED BY Manufacturer, by letter June 10, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,780 vials were distributed.
REASON Some units may exhibit non-uniform potency.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Franklin Drug Collector II (Temperature Sensor
Components), used to measure the temperature
of freshly voided urine to determine if the
urine has been adulterated, substituted or
tampered by the participant. Recall #Z-863-6.
CODE Lot numbers 07063-1, 07063-2, 07063-3.
MANUFACTURER Medical Indicators, Inc., West Trenton, New
Jersey.
RECALLED BY Franklin Diagnostics, Inc., Cedar Knolls, New
Jersey, by telephone on August 20, 1993, and
by fax. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 3,775 units were distributed.
REASON The temperature sensors were reading 2.0 F
higher than the norm.

_______________
PRODUCT Table Pad for Angix M200-4 Patient Tables:
(a) Model No. 45554028 (MP9);
(b) Model No. 45474663 (MP9);
(c) Model No. 45475314 (MP9);
(d) Model No. 45561712 (MP10).
Recall #Z-891/894-6.
CODE The table pads were to be replaced on Angix
M200-4 patient tables having the following
model and serial numbers:
Model Number Serial Numbers
45554028(MP9) 2158BU4, 4868BU6,
8831BU40, 99643
45474663(MP9) 93829, 93871, 93885
45475314(MP9) 5061BU7, 5126BU6,
5129BU2, 5178BU9,
5966BU7, 5967BU5,
5968BU3, 5969BU1,
5970BU9, 9141BU3
45561712(MP10) 8832BU8, 8927BU6,
8928BU4, 8929BU2,
10690BU6, 10691BU4,
11123BU7, 23655BU4,
24188BU5, 27619BU6,
27620BU4, 29386BU0,
30292BU7, 30996BU3,
30997BU1, 32617BU3,

-5- 34998BU5, 34999BU3,
35415BU9, 35416BU7,
35417BU5, 35418BU3,
37937BU0, 37938BU8,
38717BU5, 39016BU1,
40432BU7, 40931BU8,
44017BU2.
MANUFACTURER G.E. Medical Systems, Buc Cedex, France.
RECALLED BY General Electric Company, Waukesha, Wisconsin.
FDA approved the firm's corrective action plan
June 20, 1996. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 37 units were distributed.
REASON The devices were found noncompliant with the
requirements of 21 CFR 1020.30(n) for
cantilevered tabletops, in that the measured
aluminum equivalent thickness of the pads was
measured to be between 1.3 and 1.4 mm, while
the specifications for the pads require
aluminum equivalent thickness values between
0.2 and 0.4 mm.

_______________
PRODUCT Model E523 Laser System, used as a source of
colored light in the production of laser light
shows. Recall #Z-898-6.
CODE Serial numbers 027 and 028.
MANUFACTURER SLS Laser Systems, Pennsauken, New Jersey.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan May 20, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Florida.
QUANTITY 2 units.
REASON The laser product failed to comply with 21 CFR
1040.10(f)(5)(ii), 1040.10(f)(3),
1040.10(g)(6), 1040.10(g)(4) in that the
system lacked emission delay, an emission
indicator and an available remote control
connector. Warning labels were lacking or were
not inscribed with the correct text.

-6-

END OF ENFORCEMENT REPORT FOR JUNE 26, 1996. BLANK PAGES MAY
FOLLOW.

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