FDA

Enforcement Report

September 22, 1999                           99-38

RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
________
PRODUCT
Aussie Land Kangaroo Island Detangler Juicy Peach, in 
10.1 fluid ounce pump spray.  Recall #F-667-9.
CODE
Lot numbers:  
9G16992a   9G16168a
9G16168b   9C17104a
9E12068a   9E13789c.
MANUFACTURER
Redmond Products, Inc., Stamford, Connecticut.
RECALLED BY
Manufacturer, by mailgram/voice mail, and by press release on 
August 11, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
50,148 units.
REASON
Product is contaminated with Burkholderia cepacia.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________
PRODUCT
Lake Park brand Sweet Georgia Carrots, Net Wt 80 Oz (5 lb) 2.2 
kg.  Recall #F-668-8.
CODE
All carrots in distribution channels.
MANUFACTURER
Zellwin Produce Company, Lake Park, Georgia.
RECALLED BY
Manufacturer, by letter and telephone on June 24, 1999.  The 
State of Georgia also issued a press release regarding this 
recall on June 25, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Georgia and Florida.
QUANTITY
Undetermined.
REASON
The finding of PCNB (pesticide) on these carrots renders this 
food unsafe within the meaning of Section 408 of the FD&C Act.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- 
CLASS II
________
PRODUCT
Merrem (Meropenem for Injection), used for intra-abdominal 
infections and bacterial meningitis: a) 500 mg in 20 ml and 100 
ml vials; b) 1 gram in 30 ml, and 100 ml vials, and in 15 ml 
ADDVantage vials.  NDCs 0310-0325-11 (100 ml vial/500 mg), 0310-
0325-20 (20 ml vial/500 mg), 0310-0321-11 (100 ml vial/1 gram), 
0310-0321-15 (15 ml vial/1 gram), and 0310-0321-30 (30 ml vial/1 
gram).  Recall #D-410/411-9.
CODE
The expiration period for all lots is 8/99 - 11/01.  The lot 
numbers are as follows:
500 mg lots: 4082Y, 3105A, 3192B, 3193B, 3625A, 3720Y, 4083Y, 
4103A, 4323A, 4419Y, 4695A, 4722A, 4777A, and 4778A.
1 gram lots: 3210Y, 3228Y, 3869Y, 4409Y, 3099A, 3912A, 4410Y, 
4804Y, 3101A, 3102A, 3103A, 3107A, 3108A, 3176B, 3178B, 3179B, 
3180B, 3182B, 3183B, 3184B, 3190B, 3191B, 3212Y, 3213Y, 3214Y, 
3621A, 3622A, 3717Y, 3913A, 3914A, 3915A, 4078Y, 4078Y, 4080Y, 
4081Y, 4100A, 4101A, 4321A, 4322A, 4324A, 4325A, 4413Y, 4414Y, 
4415Y, 4719A, 4733A, 4734A, and 4806Y.
MANUFACTURER
Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
RECALLED BY
AstraZeneca, a business unit of Zeneca, Inc., Wilmington, 
Delaware, by letter on August 13, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
Approximately 2,500 cases remained on market at time of recall 
initiation.
REASON
Current good manufacturing practice deviations (at contract 
manufacturer).



RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III
________
PRODUCT
Acyclovir Tablets, Rx oral antiviral drug for the acute treatment 
of herpes zoster, initial episodes and management of recurrent 
episodes of genital herpes, and the treatment of chickenpox, 
packaged in unit dose and bottles of 100 and 500 tablets under 
the following labels:
a) 400 mg. Tablets:
i) 100 tablets/unit dose, NDC #51079-877-20, Distributed by UDL 
Laboratories, Inc., Rockford, IL;
ii) 100 tablet bottle, NDC #55953-943-40;
iii) 500 tablet bottle, NDC #55953-943-7;
b) 800 mg. Tablets: 
i) 100 tablets/unit dose, NDC #51079-878-20, Distributed by UDL 
Laboratories, Inc., Rockford, IL;
ii) 100 tablet bottle, NDC #55953-947-40;
iii) 500 tablet bottle, NDC #55953-947-70.
Recall #D-421/422-9.
CODE
The following lot numbers will be followed with letter sublot 
designations, i.e. 113569A, on the package labels:
a) 400 mg.: 113569, 108227
b) 800 mg.: 108235, 108772, 113570, 113571, 113572.
MANUFACTURER
Novopharm Ltd., Toronto, Ontario, Canada.
RECALLED BY 
Novopharm USA, Inc., Schaumburg, Illinois, by letters dated 
August 19 and 24, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
2,212 unit dose cartons, 105 500-tablet bottles and 12,737 100-
tablet bottles of 400 mg. tablets and 1,602 unit dose cartons, 
759 500-tablet bottles and 8,838 100-tablet bottles of 800 mg. 
tablets were distributed; firm estimates that 40% of the product 
remains on the market.
REASON
Softening and cracking of tablets.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
________
PRODUCT
Red Blood Cells.  Recall #B-1193-9.
CODE
Unit Numbers:  0432939, 0457464, 0121373, 0151631.
MANUFACTURER
New York Blood Services, New York, New York.
RECALLED BY
Manufacturer, by letter dated July 23, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
New York and New Jersey.
QUANTITY
4 units were distributed.
REASON
Blood products tested negative for antibody to the human 
immunodeficiency virus type 1 (anti-HIV-1), but were collected 
from a donor who previously tested repeatedly reactive for anti-
HIV-1, Western blot indeterminate.
________
PRODUCT
Platelets, Pheresis, leukoreduced.  Recall #B-1202-9.
CODE
Unit numbers: 30171-1519-01, 30172-5610-01, 30172-5610-02.
MANUFACTURER
United Blood Services, Bismarck, North Dakota.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated January 
8, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Arizona, Nevada, North Dakota.
QUANTITY
3 units were distributed.
REASON
Blood products had unacceptable platelet counts.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
________
PRODUCT
Red Blood Cells.  Recall #B-1194-9.
CODE
Unit numbers:  6016051, 6016054, 6016064, 6016069.
MANUFACTURER
Blood Bank of Alaska, Anchorage, Alaska.
RECALLED BY
Manufacturer, by telephone on June 9, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Alaska.
QUANTITY
4 units were distributed.
REASON
Blood products were leukoreduced by filtration greater than 120 
hours after refrigeration.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1200/1201-9.
CODE
Unit #30171-9524.
MANUFACTURER
United Blood Services, Bismarck, North Dakota.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on July 
20, 1998.  Firm-initiated recall complete.
DISTRIBUTION
North Dakota, Switzerland.
QUANTITY
1 unit was distributed.
REASON
Blood products were collected from a donor with an elevated body 
temperature.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- 
CLASS II
_______
PRODUCT
Rotabulator Rotalink, indicated for use in patients with coronary 
artery disease:
a) Rotablator RotaLink Plus Pre-connected Exchangeable Rotational 
Atherectomy System with Catalog Nos. 23631-002, 23631-003, 23631-
004, 23631-005, 23631-006, 23631-007, 23631-015, 23631-016;
b) Rotablator RotaLink Coronary Advancer with Catalog Nos. 22782-
001A0, 22782-0010;
c) Rotablator RotaLink Peripheral Advancer with Catalog No. 
11381-90, intended for percutaneous use in peripheral vessels in 
patients with occlusinve atherosclerotic disease who are 
acceptable candidates for bypass graft surgery or percutaneous 
transluminal angioplasty.
Recall #Z-1220/1222-9.
CODE
All lot numbers.
MANUFACTURER
Boston Scientific Corporation Northwest, Redmond, Washington.
RECALLED BY
Manufacturer, by FED-EX or fax on August 6, 1999, and by letter 
dated August 12, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Approximately 35,000 coronary devices and 280 peripheral 
advancers were distributed.
REASON
The braking mechanism may fail to secure the guidewire during 
use, which can cause the guidewire to move suddenly, resulting in 
vessel damage.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
EPROM Version 3.00 Software for the Olympus EVIS CV-140  Video 
System Center, an endoscopic video imaging system that provides 
photo/video documentation of the upper lower gastrointestinal 
tract using the EVIS 140 series video endoscopes.  Recall #Z-
1227-9.
CODE
Catalog #3010, Serial numbers:  7834678 to 7948133.
MANUFACTURER
Shirakawa Olympus Company, Ltd., Japan.
RECALLED BY
Olympus America Inc., Melville, New York, by letter on or about 
July 27, 1999.  Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
1,430 units were distributed.
REASON
The device has a malfunction due to incorrect coding of the 
software, which can cause the software to overwrite the patient 
ID number with any comments that are entered by the user.

END OF ENFORCEMENT REPORT FOR SEPTEMBER 22, 1999.  BLANK PAGES MAY 
FOLLOW.

####

---