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.
October 1, 1997 97-40
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Veragel 1:1 Purified Aloe Vera Leaf Water
Soluble Extract, in 55 blue gallon
polyethylene drums. Recall #F-822-7.
CODE Lot #6-1781, Product Code 21501-000, No
expiration date.
MANUFACTURER Madis Botanicals, South Hackensack, New
Jersey.
RECALLED BY Manufacturer, by telephone on November 13,
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 57 drums were distributed; firm estimates none
remains on the market.
REASON The product is contaminated with Enterobacter
gergoviae, an opportunistic pathogen.
_______________
PRODUCT Blue-Marlin Frozen Loins, individually wrapped
in plastic and packed into a cardboard case.
Recall #F-824-7.
CODE Lot #20140.
MANUFACTURER Costa Pesca, Quito, Ecuador
(shipper/processor).
RECALLED BY Fresh Fish Inc., Miami, Florida, by letter
faxed on June 10, 1997. Firm-initiated recall
complete.
DISTRIBUTION Florida and Maryland.
QUANTITY 1,303 pounds were distributed.
REASON Product was associated with scombroid
poisoning and contained high histamine levels.
____________
PRODUCT "The" Daily Multiple Tablets, shipped to the
repacker in a bulk fiber drum.
Recall #F-825-7.
CODE Bulk drum: lot #960135; Unit bottle: lot
#C96008.
MANUFACTURER Bactolac Pharmaceuticals, Inc., Westbury, New
York.
RECALLED BY Manufacturer, by letter mailed on August 15,
1996, followed by telephone. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY Approximately 60,000 tablets were distributed;
firm estimates none remains on the market.
REASON Product is subpotent in folic acid.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Tatum's and Country Hearth brands, Old Time
Biscuits, made with buttermilk, net weight 8
ounces. Recall #F-826-7.
CODE Pull date of 07/07/97 on bag.
MANUFACTURER Tatum Bakers, Birmingham, Alabama.
RECALLED BY Manufacturer, by visit. Firm-initiated recall
complete.
DISTRIBUTION Florida.
QUANTITY 3,260 packages were distributed. Firm
estimates none remains on the market.
REASON Product is unfit for food due to the presence
of aluminum fragments.
______________
PRODUCT Cashews under the Thrifty brand and D&W brand:
a) Whole Cashews, 2-1/4 ounces; b) Cashews
(broken kernels), 8 ounces; c) Salted Cashews,
2-3/4 ounces. Recall #F-827/829-7.
CODE All product with expiration date of 12/97 or
earlier.
MANUFACTURER Thrift Products Company, Kentwood, Michigan.
RECALLED BY Manufacturer, by telephone on June 9, 1997,
followed by visit on June 10 and 11, 1997, and
by press releases on June 9 and 10, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY Approximately 7,500 bags were distributed.
REASON The products' ingredient statement does not
list the source of the oil used for roasting.
-2-_______________
PRODUCT Minute Maid Orange Juice packaged in 9-packs
of 8.45 ounce (250 ml.) aseptic drink box
containers. Unit count per case is 27.
Recall #F-832-7.
CODE Lot number: Package: MAR0698GF
Case: XX:XX MAR0698 G20581D.
MANUFACTURER The Minute Maid Company, Geneva, Ohio.
RECALLED BY The Minute Maid Company, Houston, Texas, by
telephone on September 12, 1997, followed by
visit. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, New York, Ohio, Alabama,
Mississippi.
QUANTITY 1,383 cases were distributed.
REASON Product is contaminated with yeast.
_______________
UPDATE Recall #F-812-7, Red Sugar Cake Decoration,
which appeared in the September 24, 1997,
Enforcement Report is being amended to NOT
INCLUDE the Betty Crocker 1 ounce product.
The Kroger Brand Red Sugar Cake Decoration is
correctly included under Recall #F-812-7.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I ============
_______________
PRODUCT Prograf Tacrolimus Capsules, 1 mg, in bottles
of 100, Rx oral drug indicated for the
prophylaxis of organ rejection in patients
receiving allogenic liver transplants.
Recall #D-276-7.
CODE Lot 1C3062B EXP 4/30/99.
MANUFACTURER Fujisawa Ireland Ltd., Republic of Ireland.
RECALLED BY Fujisawa USA, Inc., Deerfield, Illinois, by
letters dated September 3 and 5, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 6,890 bottles were distributed; firm estimated
that 25-30% of product remained on market at
time of recall initiation.
REASON Mislabeling -- At least one bottle labeled to
contain 1 mg capsules actually contained 5 mg
capsules.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Gentamicin Sulfate Injection, USP, 40 mg/mL,
in 20 ml multiple dose vials, under the
following labels: Steris, Rugby, Goldline
(Zenith on label). Recall #D-277-7.
CODE Lot #95K550.
-3-MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY Manufacturer, by letter on March 31, 1997.
Firm-initiated.
DISTRIBUTION Nationwide.
QUANTITY 19,000 vials were distributed.
REASON White precipitate in product (preservatives).
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Platelets. Recall #B-1389-7.
CODE Unit #16337-9672.
MANUFACTURER Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY Manufacturer, by letter dated April 8, 1997.
Firm-initiated recall complete.
DISTRIBUTION Mississippi.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red
Blood Cells that was reported as clotted.
_______________
PRODUCT Allergenic Extract and Allergenic Treatment
Sets. Recall #B-1412-7.
CODE Lot # 648304, 653265, 663176, 666156, 668804,
668925, 668926, 670458, 671334, 678222,
678223, 678224, 678225, 678226, 678227,
678228, 678229, 678230, 678231, 678232,
678233, 678234, 678235, 678236, 678237,
678238, 678239, 678240, 678241, 692263,
693755.
MANUFACTURER ALK Laboratories, Berkeley, California.
RECALLED BY Manufacturer, by letter on August 16 and 27,
1997, followed by telephone. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 31 lots.
REASON Lack of assurance that products met sterility
testing requirements prior to release.
_______________
PRODUCT Platelets, Pheresis. Recall #B-1465.
CODE Unit numbers: 16333-9425 and 16333-9430,
MANUFACTURER Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY Manufacturer, by letter dated October 23,
1996. Firm-initiated recall complete.
DISTRIBUTION Mississippi.
QUANTITY 2 units were distributed.
REASON Blood products may have been labeled with an
extended expiration date.
_______________
PRODUCT Red Blood Cells. Recall #B-1468-7.
CODE Units 49FJ53975, 49FJ55367, 49FM26720.
-4-MANUFACTURER American National Red Cross, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by letters dated July 1, 1997,
and August 4, 1997. Firm-initiated recall
complete.
DISTRIBUTION Oklahoma and Texas.
QUANTITY 3 units were distributed.
REASON Blood product was collected from a donor who
reported travel to an area designated as
endemic for malaria.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-1472/1473-7.
CODE Unit 29271-0984.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on May 29, 1997,
and by letter dated July 8, 1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of cancer.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1474/1475-7.
CODE Unit numbers: a) 10005367, 13000623,
31006566, 31006572; b) 31006566, 31006572.
MANUFACTURER W.E. & Lela I. Stewart Blood Center, Inc,
Tyler, Texas.
RECALLED BY Manufacturer, by telephone on March 19, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY a) 4 units; b) 2 units were distributed.
REASON Blood products tested repeatedly reactive for
the Hepatitis B Surface Antigen (HBsAg), were
distributed.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-1492/1493-7.
CODE Unit numbers: a) 10161-2218 and 10158-5733;
b) 10156-1459, 10161-2218, 10158-5733.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letters dated July 5, 1996, and December 10,
1996. Firm-initiated recall complete.
DISTRIBUTION Arizona and California.
QUANTITY a) 2 units; b) 3 units were distributed.
-5-REASON Blood products tested negative for the
antibody to the human T-lymphotropic virus
type I (anti-HTLV-I), but were collected from
a donor who previously tested repeatedly
reactive for anti-HTLV-1.
_______________
PRODUCT Platelets. Recall #B-1494-7.
CODE Unit #10525-2279.
MANUFACTURER Blood Systems, Inc., Scottsdale, Arizona.
RECALLED BY Manufacturer, by telephone on February 28,
1997. Firm-initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
Whole Blood with an extended collection time.
_______________
PRODUCT Red Blood Cells. Recall #B-1496-7.
CODE Unit #M96019058.
MANUFACTURER United Blood Services, Ventura, California.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on June 20, 1996. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected in a manner that
could compromise the sterility of the product.
_______________
PRODUCT Red Blood Cells. Recall #B-1497-7.
CODE Unit #4661234.
MANUFACTURER Naval Hospital, Groton, Connecticut.
RECALLED BY Manufacturer, by telephone on August 28, 1997.
Firm-initiated recall complete.
DISTRIBUTION Haiti.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for
the antibody to the hepatitis B core antigen
(anti-HBc).
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =====
_______________
PRODUCT a) Red Blood Cells; b) Cryoprecipitate AHF.
Recall #B-1286/1287-7.
CODE Unit 21045-1515.
MANUFACTURER United Blood Services, Fargo, North Dakota.
RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by
letter dated July 25, 1997. Firm-initiated
recall complete.
DISTRIBUTION North Dakota, Louisiana.
QUANTITY 1 unit of each component was distributed.
-6-REASON Blood products, which tested non-reactive for
the antibody to the Hepatitis B core antigen
(anti-HBc), but were collected from a donor
who was previously repeatedly reactive for
anti-HBc.
_______________
PRODUCT Recovered Plasma, Frozen. Recall #B-1461-7.
CODE 25FS25282, 25FS25283, 25FS25284, 25FS25286,
25FS25287, 25FS25285, 25FS25288, 25FS25289,
25FS25291, 25FS25292, 25FS25293, 25FS25294,
25FS25295, 25FS25296, 25FS25297, 25FS25298,
25FS25299, 25FS25300, 25FS25301, 25FS25302,
25FS25303, 25FS25304, 25FS25306, 25FS25307,
25FS25308, 25FS25309, 25FS25310.
MANUFACTURER American Red Cross Blood Services, Syracuse,
New York.
RECALLED BY Manufacturer, by E-mail and by fax on June 28,
1996. Firm-initiated recall complete.
DISTRIBUTION California and Switzerland.
QUANTITY 27 units were distributed.
REASON Blood product was prepared from Whole Blood
which may have reached unacceptable
temperature during shipment.
_______________
PRODUCT Red Blood Cells. Recall #B-1477-7.
CODE Unit #10239-8348.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on September 13, 1994. Firm-initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
_______________
PRODUCT Platelets. Recall #B-1478-7.
CODE Unit #10524-3527.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on February 28, 1997. Firm-initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
Whole Blood with an extended collection time
and designated as a "difficult collection."
_______________
PRODUCT Red Blood Cells. Recall #B-1479-7.
-7-CODE Unit numbers: 10521-6637, 10521-6636,
10521-6635.
MANUFACTURER United Blood Services, Scottsdale, Arizona
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on January 22, 1997. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 3 units were distributed.
REASON Blood products were labeled with extended
expiration dates.
_______________
PRODUCT Platelets. Recall #B-1480-7.
CODE Unit numbers: 10238-3924, 10238-3920,
10238-3926, 10238-2741, 10238-2737,
10238-2739, 10238-4953, 10238-3928,
10238-3929, 10238-4792.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated August 22, 1994. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 10 units were distributed.
REASON Blood products were shipped at an unacceptable
temperature.
_______________
PRODUCT Red Blood Cells. Recall #B-1495-7.
CODE Unit numbers: 36247-0348, 36247-0134,
36247-0132.
MANUFACTURER United Blood Services, Ventura, California.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on October 1, 1996. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 3 units were distributed.
REASON Blood products may have been stored at an
unacceptable temperature.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I ==========
_______________
PRODUCT Solar 8000 Bedside Patient Monitor.
Recall #Z-908-7.
CODE Serial numbers beginning with B7, C7, D7, E7,
FAll monitors manufactured between February 1,
1997 and July 10, 1997, with s7 or G7.
MANUFACTURER Marquette Electronics, Inc., Milwaukee,
Wisconsin.
RECALLED BY Manufacturer, by letter on August 15, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international..
QUANTITY 1,769 units were distributed.
-8-REASON The speaker of the monitor may fail to audibly
alarm due to the inappropriate length of the
speaker lead wire.
_______________
PRODUCT Lead Aprons, Collars, and Gonadal Shields.
Recall #Z-912/914-7.
CODE Products received from vendor between 5/97 and
7/97. No lot number or catalog number.
MANUFACTURER Burlington Medical, Inc., Newport News,
Virginia.
RECALLED BY Manufacturer, by letter on July 15, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON The radiation protection devices contain lead
contaminated with small amounts of radioactive
substances.
_______________
PRODUCT Ultra-Flex Adult Anesthesia Breathing
Circuits:
1. Product No. 51213F-6154
2. Product No. 5613B-61
3. Product No. 5613F-61
4. Product No. 5613F-80
5. Product No. 5753B-61
6. Product No. 5753F-10021
7. Product No. 61453B-8015X
8. Product No. 6753F-13621
9. Product No. 8613B-164
10. Product No. 8613B-84X
11. Product No. 8613F-13633
12. Product No. 8613F-164E
13. Product No. 8613F-61
14. Product No. 8613F-6121
15. Product No. 8613F-80
16. Product No. 8613F-84
17. Product No. 8613F-8433
18. Product No. 8752B-84X
19. Product No. 8753B-61
20. Product No. 8753F-104
21. Product No. 8753F-231
22. Product No. 8753F-248
23. Product No. 8753F-249
24. Product No. 8753F-61
25. Product No. 90337
26. Product No. 90358
27. Product No. Q5753F-28B31.
Recall #Z-915/941-7.
CODE Lot numbers:
1. 1947E7
2. 0236F7, 1948E7
-9- 3. 0237F7, 1337E7
4. 1238F7
5. 0101F7
6. 2296E7
7. 0680F7
8. 2058E7
9. 0586F7, 1341E7
10. 1139E7, 0243F7, 0213E7, 1205F7
11. 0101F7, 2300E7, 1728E7
12. 1342E7
13. 0244F7, 1952E7, 2158E7
14. 0587F7
15. 1037F7, 1343E7, 1953E7
16. 1282F7
17. 1212E7
18. 0504F7
19. 0505F7, 1603E7
20. 2061E7, 0104F7
21. 0105F7
22. 0247F7
23. 2062E7, 0106F7, 1346E7, 0248F7
24. 0250F7, 2041E7
25. 1734E7
26. 2042E7
27. 0002F7.
MANUFACTURER King Systems Corporation, Noblesville,
Indiana.
RECALLED BY Manufacturer, by fax on August 11, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Singapore.
QUANTITY 328 cases were distributed.
REASON The expandable tube is breaking around the
circumference of the tube.
SAFETY ALERTS: ==============================================
_______________
PRODUCT Autopheresis-C Plasmapheresis System.
Safety Alert #N-028-7.
CODE Model A-200, Model A-201, Model A-401.
MANUFACTURER Baxter Healthcare Corporation, Largo, Florida.
ALERTED BY Baxter Healthcare Corporation, Deerfield,
Illinois, by letter on August 4, 1997.
DISTRIBUTION Nationwide.
QUANTITY 5,229 instruments were distributed.
REASON The use of 250 ml anticoagulant containers may
result in the potential for donor air embolus
when performing plasmapheresis with the
Autopheresis-C instrument.
-10-
END OF ENFORCEMENT REPORT FOR OCTOBER 1, 1997. BLANK PAGES MAY FOLLOW.
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