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
07/07/1993
Recalls and Field Corrections: Foods -- Class I -- 07/07/1993
July 7, 1993
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
=========================
_______________
PRODUCT Stouffer's Lunch Express brand Cheese
Ravioli with Tomato Sauce, 8.5 ounces,
packaged frozen entree.
Recall #F-489-3.
CODE Lot numbers: 2252GS9, 2300GS9,
2312GS9, 3011GS9, 3035GS9.
MANUFACTURER Stouffer Foods Corporation, Gaffney,
South Carolina.
RECALLED BY Stouffer Foods Corporation, Solon,
Ohio, by letter February 18, 1993.
Firm-initiated recall complete.
DISTRIBUTION East of the Mississippi.
QUANTITY 19,728 cases (12 packages per case)
were distributed.
REASON The product contains eggs and eggs are
not declared on the label.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
========================
_______________
PRODUCT Coastal brand Deep Sea Frozen Lobster
Tails, imported from India, in 1.5 kg
pound packages. Recall #F-490-3.
CODE SL. 882 E 518 on master carton. 2D04,
VARIETY FDLT on unit packages. There
are 9 sizes of lobster tails in the
shipment: 6/8, 9/12, 13/15, 16/18,
18/24, 24/30, 30/40, 40/50, and 55/up.
Each unit block is coded 2D04, FDLT,
and size.
MANUFACTURER Nekkanti Seafoods Ltd., Visakhapatnam,
India.
RECALLED BY Torry Harris, Inc., Perth Amboy, New
Jersey, by letter February 10, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Florida, New York, New Jersey.
QUANTITY 1,120 cartons of 33 pounds each were
distributed.
REASON The product contains undeclared
sulfites.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
========================
______________
PRODUCT ACTH Injection, 40 unit/vial, in
cartons of 10's and packaged in 100's.
Recall #D-285-3.
CODE Lot numbers: 02182P EXP 9/93, 03172P
EXP 9/93, 04052P EXP 7/93.
MANUFACTURER Parke-Davis, Division of Warner-Lambert
Company, Rochester, Michigan.
RECALLED BY Parke-Davis, Division of Warner-Lambert
Company, Morris Plains, New Jersey by
letter February 9, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 23,190 vials of lot 04052P, 24,800 of
lot 03172P, 6,786 vials of lot 02182P
were distributed.
REASON Potency not assured through expiration
date.
_______________
PRODUCT Clindamycin Phosphate Injection , USP,
600 mg, 150 mg/ml, a Rx semisynthetic
antibiotic used in the treatment of
serious infections. Recall #D-286-3.
CODE Lot 921057 EXP 10/93.
MANUFACTURER SoloPak Laboratories, Division of Smith
& Nephew, Inc., Elk Grove Village,
Illinois.
RECALLED BY SoloPak Pharmaceuticals, Elk Grove
Village, Illinois, by letter June 18,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 29,200 vials were distributed; firm
estimates 18,980 vials remain on the
market.
REASON Subpotency.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
=======================
_______________
PRODUCT Acetaminophen and Codeine Phosphate
Tablets, 300 mg/60 mg, in bottles of
100's and 500's, a Rx drug indicated
for the relief of mild to moderately
severe pain. Recall #D-284-3.
CODE All lots within expiration date.
MANUFACTURER Barr Laboratories, Inc., Northvale, New
Jersey.
RECALLED BY Barr Laboratories, Inc., Pomona, New
York, by letter June 16, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 184,935 bottles were distributed; firm
estimates that no product is currently
available in commerce with 1993 or 1994
expiration dates and expects to account
for approximately 1/3 of product with a
1995 expiration date.
REASON Potency not assured through expiration
date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
_______________
PRODUCT Platelets. Recall #B-308-3.
CODE Unit #2307486.
MANUFACTURER Gulf Coast Regional Blood Center,
Houston, Texas.
RECALLED BY Manufacturer, by telephone and
facsimile on April 8, 1993. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood products contaminated with
Serratia species, probable liquefaciens
were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
===================
_______________
PRODUCT Recovered Plasma. Recall #B-309-3.
CODE Unit #2307486.
MANUFACTURER Gulf Coast Regional Blood Center,
Houston, Texas.
RECALLED BY Manufacturer, by telephone on April 8,
1993. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood products contaminated with
Serratia species, probable liquefaciens
were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
======================
______________
PRODUCT Air-Shields Model PTL68 Micro-Lite
Phototherapy Light, used to reduce
serum bilirubin levels in infants.
Recall #Z-555-3.
CODE All lots.
MANUFACTURER Air Shields-Vickers, Inc., Hatboro,
Pennsylvania.
RECALLED BY Manufacturer, by Quality Assurance
Bulletin dated November 10, 1992.
Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 115 units were distributed.
REASON Lamp output may cause rapid infant
warming of up to 2 degrees C.
_______________
PRODUCT Critikon, Inc. Dinamap 8700 Series
Oximeters/Monitors, designed for
noninvasive monitoring of pataients in
numerous settings:
(a) Dinamap Plus Model 8700, monitors
blood pressure and pulse oximetry;
(b) Dinamap Plus Model 8710, adds the
monitoring function of ECG to the
features of Model 8700;
(c) Dinamap Plus Model 8720 includes
monitoring blood pressure,
pulseoximetry, ECG, temperature and two
invasive pressure channels;
(d) Dinamap Plus Model 8721 has the
same features as the 8720 except it
opeates at 220/240 volts and all the
other models operate at a 120 volt
current. Recall #Z-556/559-3.
CODE Serial numbers: Model 8700 - 2343,
2350-2352, 2354-2358, 2361, 2457-2459,
2462-2464, 2466, 2589-2599, 2601, 2602,
2613, 2633, 2634; Model 8710 - 2368,
2400, 2421, 2441, 2447, 2450, 2454,
2456, 2483, 2485, 2490, 2529, 2533,
2534, 2539, 2546-2550, 2554, 2555,
2557, 2559, 2561; Model 8720 - 2072,
2393, 2394, 2398, 2399, 2402, 2404,
2405, 2408, 2411, 2412, 2414-2420,
2424, 2438, 2442-2445, 2448, 2449,
2453, 2580.
MANUFACTURER Mentor Graphics, Inc., Wilsonville,
Oregon (analog boards).
RECALLED BY Critikon, Inc., Tampa, Florida, by
telephone February 8 and 9, 1993,
followed by letter February 9, 1993.
All international consignees were
contacted by telefax on February
8,1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Argentina, Chile, France,
China, Thailand, Portugal.
QUANTITY 111 units were distributed.
REASON An improperly produced circuit board
may result in erroneous saturated
oxygen levels.
SEIZURES:
=======================================================
________________
PRODUCT Condoms (93-669-873, et al.).
CHARGES Adulterated - The articles' quality
falls below that which they purport and
are represented to possess in that they
contain excessive holes. Misbranded -
The labeling for the prevention of
sexually transmitted diseases is false
and misleading because the articles
contain holes.
FIRM Brendamour Warehousing, Moving,
Distribution & Services, Inc.,
Cincinnati, Ohio.
FILED May 25, 1993; U.S. District Court for
the Southern District of Ohio, Western
Division; Civil #C-1-93-363; FDC
#66690.
SEIZED June 3, 1993 - 4 million condoms,
valued at approximately $100,781.
________________
PRODUCT Sun-Dried Figs (93-662-106/7).
CHARGE Adulterated - The article contains live
insects and mites.
FIRM Ziyad Brothers, Division of Syrian
Bakery and Grocery Company, Inc.,
Chicago, Illinois,
FILED May 26, 1993; U.S. District Court for
the Eastern District of Illinois; Civil
#93 C 3164; FDC #66693.
SEIZED June 3, 1993 - goods valued at
approximately $14,000.
________________
PRODUCT Dry garlic (92-556-465).
CHARGES Adulterated - The article is
decomposed.
Misbranded - The article's label fails
to bear the name and
place of business of the manufacturer,
packer, or
distributor and a statement of the net
quantity of contents
in terms of avoirdupois pound and
ounce.
FIRM Southeastern Food Supplies, Miami,
Florida.
FILED February 11, 1993; U.S. District Court
for the Southern
District of Florida; Civil
#CIV-93-0277; FDC #66648.
SEIZED March 11, 1993 - goods valued at
approximately $1,610.
INJUNCTION:
=======================================================
________________
CORRECTION The June 23, 1993, FDA Enforcement
Report erroneously indicated that the
U.S. District Court for the District of
New Jersey had entered a contempt order
against Able Laboratories on May 25,
1993. This report was inaccurate. FDA
and Able agreed to resolve outstanding
issues without further litigation by
amending the existing order of
permanent injunction to include
additional remedies for FDA. As part of
this settlement, A.L. Laboratories, the
owner of Able Laboratories, paid to the
U.S. Treasury $45,611, representing the
inspectional and legal costs incurred
by FDA and the Department of Justice.
-5-
END OF ENFORCEMENT REPORT FOR JULY 7, 1993. BLANK
PAGES MAY FOLLOW.
####