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.
April 16, 1997 97-16
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ===========
_______________
PRODUCT Buitoni Fresco Two Cheese Basil Tortelloni,
packed in 255 gram plastic round tubs.
Recall #F-362-7.
CODE "Best Before/Meilleur avant 97 MR 04 7020 DV4
12"; "Best Before/Meilleur avant 97 MR 11 7027
DV4 14"; and "Best Before/Meilleur avant 97 MR
18 7034 DV4 12".
MANUFACTURER Nestle Food Division, Inc., Danville, Virginia.
RECALLED BY Nestle USA - Food Division, Inc., Solon, Ohio,
by letter on February 19, 1997. Firm-initiated
recall complete.
DISTRIBUTION Canada.
QUANTITY 690 cases (6 tubs per case) were distributed
REASON Product contained undeclared walnuts.
_______________
PRODUCT Caramel Chocolate Dessert, heart-shaped pie.
Recall #F-363-7.
CODE All product shipped without an ingredient
statement.
MANUFACTURER Full Service Foods, Hillsboro, North Dakota.
RECALLED BY Harry & David, Medford, Oregon, by telephone
beginning on February 8, 1997, by mailgram on
February 11, 1997, and by letter on February
13, 1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY Product shipped to 220 recipients.
REASON The product was shipped without an ingredient
statement and contains the following allergens:
pecans, egg whites, flour and dairy products
(evaporated milk and whipping cream).
_______________
PRODUCT Grand Bay Fresh Backfin Crabmeat.
Recall #F-372-7.
CODE None.
MANUFACTURER Grand Bay Seafood, Inc., Grand Bay, Alabama.
RECALLED BY Manufacturer, by telephone on September 9 and
12, 1996. Completed recall resulted from
sample analysis and followup by the State of
Alabama.
DISTRIBUTION Alabama, Florida, Georgia, Louisiana, Maryland,
Pennsylvania, Virginia.
QUANTITY 544 pounds were distributed.
REASON Product was contaminated with Listeria
monocytogenes and was decomposed.
_______________
PRODUCT Tropic Isle Fresh Frozen Coconut, flake grated
in 6 ounce and 12 ounce poly bags.
Recall #F-377-7.
CODE All lots manufactured in Costa Rica.
MANUFACTURER Yucatica S.A., Costa Rica.
RECALLED BY Southern Frozen Foods, A Division of Curtis
Burns Foods, Montezuma, Georgia, by press
release on March 5, 1997, and by letter. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Between 18,000 and 200,000 cases (12 bags per
case were distributed
REASON Product may be contaminated with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Various donut products:
(a) P/Fried Jumbo Y/R Ring (Jumbo Ring Donut),
item #2108, 2.60 oz. each, 108/case, case net
wt. 17.55 lbs., when received by the retail
store, these donuts may be iced, glazed, or
decorated prior to sale.
(b) Raised Ring Donut (Ring Donut), item #2171,
2.00 oz. each, 108/case, case net wt. 13.50
lbs., when received by the retail store, these
donuts may be iced, glazed, or decorated prior
to sale.
-2- (c) Bismarks, Unfilled, item #2172, 2.00 oz.
each, 108/case, case net wt. 13.50 lbs.,
The retail store fills the Bismarks prior to
sale.
(d) Raspberry Filled Bismark, item #2173, 3.00
oz. each, 84/case, case net wt. 15.75 lbs.,
(e) Bismark (Bavarian Creme Filled), item
#2174, 3.00 oz. each, 84/case, case net wt.
15.75,
(f) French Crueller, item #2116, 1.35 oz. each,
84/case, case net wt. 7.09 lbs.,
(g) Bismark (Variety Pack), item #2190, 3.00
oz. each, 84/case, case net wt. 15.75 lbs.,
The flavors included in this are lemon,
apple, and raspberry.
(h) Sour Cream Cake Donut, item #2166, 2.00 oz.
each, 144/case, case net wt. 18.00 lbs.,
(i) Blueberry Cake Donut, item #3216, 1.75 oz.
each, 144/case, case net wt. 15.75 lbs.,
(j) Devils Food Cake Donut, item #2163, 2.00
oz. each, 144/case, case net wt. 18.00 lbs.
Recall #F-352/361-7.
CODE Lot numbers: (a) 0902975600, 0908976108,
0912976564, 0911976467, 0916976873, 0901975436,
0917977050
(b) 0917977051, 0912976563, 0902975601,
0908976109, 0916976872
(c) 0903975716, 0904975803, 0909976222,
0911976464
(d) 0903975718, 0904975840, 0911976466
(e) 0903975717, 0904975805, 0909976223,
0911976573, 0904975941
(f) 0905975920, 0913976703, 0915976717
(i) 0910976327; (g) 0904975804 and 0911976465
(h) 0910976326 and 0918977234
(j) 0910976328 and 0917977121.
MANUFACTURER Hazelwood Farms Bakeries, Inc., Hazelwood,
Missouri.
RECALLED BY Manufacturer, by telephone and electronic mail
on March 27, 1997, followed by fax. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 5,126 cases of bakery products containing 84-
144 pieces per case were distributed between
March 5 and 25, 1997.
REASON The products may be contaminated with hepatitis
A.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Grand Bay brand Fresh Crabmeat, produced 09/01-
04/96:
-3- (a) Claw Crabmeat; (b) Jumbo Lump Crabmeat; (c)
Lump Crabmeat; (d) Cocktail Claw Fingers
Crabmeat. Recall #F-373/376-7.
CODE None.
MANUFACTURER Grand Bay Seafood, Inc., Grand Bay, Alabama.
RECALLED BY Manufacturer, by telephone on September 9,
1996. Completed recall resulted from sample
analysis and followup by the State of Alabama.
DISTRIBUTION Alabama, Florida, Georgia, Louisiana, Maryland,
Pennsylvania, Virginia.
QUANTITY (a) 899 pounds; (b) 1,255 pounds; (c) 582
pounds; (d) 1,905 pounds were distributed.
REASON (a) Product was decomposed and produced under
insanitary conditions that could contaminate
the product with filth. Products (b), (c), and
(d) were produced under insanitary conditions
that could contaminate the product with filth.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ==========
_______________
PRODUCT Minocycline HCl Capsules, USP, 50 mg and 100
mg, used as an antimicrobial, under the Schein,
Duramed and Medicis labels.
Recall #D-134/135-7.
CODE Lot numbers: Schein label:
50 mg: All lots with exp. dates through 8/98,
PLUS P6K0148 and P6K0149
100 mg: All lots with exp. dates through
8/98, PLUS P6K0142 and P6K0143
Duramed label:
50 mg: C6A0011, C6A0111, C6C0517, C6C0518
100 mg: C5M2834, C5M2844, C6C0687
Medicis label:
50 mg: All lots with exp. dates through 11/98
100 mg (bottles of 50) - All lots w/exp dates
through 7/98 100 mg (bottles of 500) - All lots
w/exp dates through 6/98.
MANUFACTURER Danbury Pharmacal, Inc., Carmel, New York; and
Danbury Pharmacal P.R., Inc., Humacao, Puerto
Rico.
RECALLED BY Danbury Pharmacal, Inc., Brewster, New York, by
letter on February 26, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Chile.
QUANTITY Total distributed
50 mg 100 mg
Schein 226,095x100s 538,822x50s
Duramed 7,470x100s 11,178x50s
Medicis 46,345x100s 57,107x50s
Medicis 4,084x500s 4,508x500s.
-4-REASON Bulk Minocycline was recalled by Roussel
Corporation (parent firm of Biochimica Opos)
due to AADA discrepancies regarding the
manufacturing process; AADA was withdrawn.
_______________
PRODUCT Doxycycline Hyclate 100 mg tablets, 50 mg
capsules and 100 mg capsules labeled
"Manufactured by Halsey Drug Co., Inc.,
Brooklyn, N.Y.", "Manufactured by: Rachelle
Laboratories, Inc., Culver, Indiana", "Mfd. by:
Rachelle-Houba Laboratories, Inc., Culver,
Indiana, a subsidiary of Halsey Drug Co., Inc.,
Brooklyn, N.Y.", or "Manufactured by Rachelle
Laboratories, Inc., Culver, Indiana, A
Subsidiary of Halsey Drug Co., Inc., Brooklyn,
NY" as follows:
1. ALIGEN Doxycycline Hyclate Tablets, USP 100
mg in bottles of 50 tablets distributed by
Aligen Independent Laboratories, Inc.,
2. ALIGEN Doxycycline Hyclate Tablets, USP 100
mg in bottles of 500 tablets distributed by
Aligen Independent Laboratories, Inc.,
3. APOTHECON Doxycycline Hyclate Tablets, USP
100 mg in bottles of 50 tablets, Manufactured
for APOTHECON, A Bristol-Myers Squibb Co.,
4. APOTHECON Doxycycline Hyclate Tablets, USP
100 mg in bottles of 500 tablets, Manufactured
for APOTHECON, A Bristol-Myers Squibb Co.,
5. APOTHECON Doxycycline Hyclate 100 mg
capsules, USP in bottles of 50 capsules,
APOTHECON, A Bristol-Myers Squibb Co.,
6. APOTHECON Doxycycline Hyclate 100 mg
capsules, USP in bottles of 500 capsules,
APOTHECON, A Bristol-Myers Squibb Co.,
7. Doxychel Doxycycline Hyclate Tablets USP
100 mg in bottles of 50 tablets, Rachelle
Laboratories, Inc.,
8. Doxychel Doxycycline Hyclate Tablets USP
100 mg in bottles of 500 tablets, Rachelle
Laboratories, Inc.,
9. Doxychel Doxycycline Hyclate Capsules USP
100 mg in bottles of 50 capsules, Rachelle
Laboratories, Inc.,
10. Geneva Doxycycline Hyclate Tablets, USP 100
mg in bottles of 50 tablets, distributed By
Geneva Pharmaceuticals, Inc.,
11. Geneva Doxycycline Hyclate Tablets, USP 100
mg in bottles of 500 tablets, distributed by
Geneva Pharmaceuticals, Inc.,
-5- 12. Geneva Doxycycline Hyclate 50 mg capsules,
USP in bottles of 50 capsules distributed by
Geneva Pharmaceuticals, Inc.,
13. Geneva Doxycycline Hyclate 100 mg capsules,
USP in bottles of 50 capsules distributed by
Geneva Pharmaceuticals, Inc.,
14. Geneva Doxycycline Hyclate 100 mg capsules,
USP in bottles of 500 capsules distributed by
Geneva Pharmaceuticals, Inc.,
15. HALSEY Doxycycline Hyclate Tablets, USP 100
mg in bottles of 50 tablets, Manufactured by:
Rachelle [or Rachelle-Houba] Laboratories,
Inc.,
16. HALSEY Doxycycline Hyclate Tablets, USP 100
mg in bottles of 500 tablets, Manufactured by:
Rachelle [or Rachelle-Houba] Laboratories,
Inc.,
17. HALSEY Doxycycline Hyclate 50 mg capsules,
USP in bottles of 50 capsules, Halsey Drug Co.,
Inc.,
18. HALSEY Doxycycline Hyclate 100 mg capsules,
USP in bottles of 50 capsules, Halsey Drug Co.,
Inc.,
19. HALSEY Doxycycline Hyclate 100 mg capsules,
USP in bottles of 500 capsules, Halsey Drug
Co., Inc.,
20. Major Doxycycline Hyclate Tablets, USP 100
mg in bottles of 50 tablets, Manufactured for
Major Pharmaceutical Corp.,
21. Major Doxycycline Hyclate Tablets, USP 100
mg in bottles of 500 tablets, Manufactured for
Major Pharmaceutical Corp.,
22. Major Doxycycline Hyclate 50 mg capsules,
USP in bottles of 50 capsules Major
Pharmaceutical Corp.,
23. Major Doxycycline Hyclate 100 mg capsules,
USP in bottles of 50 capsules Major
Pharmaceutical Corp.,
24. Major Doxycycline Hyclate 100 mg capsules,
USP in bottles of 500 capsules distributed by
Major Pharmaceutical Corp.,
25. Mason Doxycycline Hyclate 100 mg capsules,
USP in bottles of 500 capsules distributed by
Mason Distributors, Inc.,
26. Moore Doxycycline Hyclate Tablets, USP 100
mg in bottles of 50 tablets distributed by h.l.
Moore Drug Exchange, and labeled
27. Moore Doxycycline Hyclate Tablets, USP 100
mg in bottles of 500 tablets, distributed by
h.l. Moore Drug Exchange,
-6- 28. Moore Doxycycline Hyclate 50 mg capsules,
USP in bottles of 50 capsules distributed by
h.l. Moore Drug Exchange,
29. Moore Doxycycline Hyclate 100 mg capsules,
USP in bottles of 50 capsules distributed by
h.l. Moore Drug Exchange,
30. Moore Doxycycline Hyclate 100 mg capsules,
USP in bottles of 500 capsules distributed by
h.l. Moore Drug Exchange,
31. PARMED Doxycycline Hyclate 50 mg capsules,
USP in bottles of 50 capsules distributed by
Parmed Pharmaceuticals, Inc.,
32. PARMED Doxycycline Hyclate 100 mg capsules,
USP in bottles of 50 capsules distributed by
Parmed Pharmaceuticals, Inc.,
33. Qualitest Doxycycline Hyclate Tablets, USP
100 mg in bottles of 50 tablets, and labeled
"Mfg. for: QUALITEST PRODUCTS, INC.,
34. Qualitest Doxycycline Hyclate Tablets, USP
100 mg in bottles of 500 tablets, Mfg. for:
QUALITEST PRODUCTS, INC.,
35. Qualitest Doxycycline Hyclate 50 mg
capsules, USP in bottles of 50 capsules and
labeled "Mfg. for: QUALITEST PRODUCTS, INC.,
36. Qualitest Doxycycline Hyclate 100 mg
capsules, USP in bottles of 50 capsules
QUALITEST PRODUCTS, INC.,
37. Qualitest Doxycycline Hyclate 100 mg
capsules, USP in bottles of 500 capsules
QUALITEST PRODUCTS, INC.,
38. Warner Chilcott Doxycycline Hyclate
Tablets, USP 100 mg in bottles of 50 tablets,
Manufactured for WARNER CHILCOTT LABS Div of
Warner-Lambert Co.,
39. Warner Chilcott Doxycycline Hyclate
Tablets, USP 100 mg in bottles of 500 tablets,
Manufactured for WARNER CHILCOTT LABS Div of
Warner-Lambert Co.,
40. WARNER CHILCOTT Doxycycline Hyclate 50 mg
capsules, USP in bottles of 50 capsules WARNER
CHILCOTT LABS, Div of Warner-Lambert Co.,
41. WARNER CHILCOTT Doxycycline Hyclate 100 mg
capsules, USP in bottles of 500 capsules
Manufactured for: WARNER CHILCOTT LABS, Div of
Warner-Lambert Co. Recall #D-141/143-7.
CODE APOTHECON Lots: 4J98931, 4J98942, 4J98953,
4K98332, 5F06053, 5F07390, 5F07401, 5G06064,
5K09524, 5L09535, 5M08132, 6A18143, 6A18154,
6A19452, 6F16377, 6F16388, 6J16668, 6F16701,
6J16723, 6L16690.
-7- The following lot numbers of the brands other
than APOTHECON are under recall:
50 mg. capsules: These products bear seven
digit lot numbers and the first three digits
are 552.
For lots ending in the number 5: Lots
containing the numbers 02 or a larger number as
the fourth and fifth digits and the letter R as
the sixth digit. All codes ending in a 5 and
containing the letter W.
For lots ending in the number 6: All lots
containing the letter A, B, C, D, E, F, G, H,
K, or M.
100 mg. capsules: These products bear seven
digit lot numbers and the first three digits
are 553.
For lots ending in the number 5: All codes
containing the letter K, M, R, or W PLUS all
codes with the numbers 05 or a larger number in
the fourth and fifth positions and containing
an H in the code.
For lots ending in the number 6: All lots
containing the letter A, B, C, D, E, F, G, H,
or K PLUS all codes with the number/letter
combination 01M or 02M.
100 mg. tablets: These products bear seven
digit lot numbers and the first three digits
are 581.
For lots ending in the number 4: All codes
containing the letter H, K, M, R, or W.
For lots ending in the number 5: All codes.
For lots ending in the number 6: All codes
containing the letter A, B, C, D, E, F, G, H,
K, or M.
MANUFACTURER Houba, Inc., A Subsidiary of Halsey Drug Co.,
Inc., Culver, Indiana.
RECALLED BY letter dated January 3, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 150 million capsules were
distributed.
REASON ANDA discrepancies and lack of assurance of
stability.
_______________
PRODUCT Lederle brand Cefaclor Capsules, USP, 250 mg
and 500 mg, Rx antibiotic.
Recall #D-146/147-7.
CODE All lots within expiration date.
MANUFACTURER Lederle Laboratories, Pearl River, New York.
-8-RECALLED BY Wyeth-Ayerst Laboratories, St. Davids,
Pennsylvania, by letter dated February 19,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 692,229 bottles were distributed.
REASON Bulk Cefaclor was recalled b Roussel Corp.
(parent firm of Biochimica Opos) due to AADA
discrepancies regarding the manufacturing
process; AADA was withdrawn.
_______________
PRODUCT Lederle brand Cefaclor for Oral Suspension,
USP, 125 mg/5 ml, 187 mg/5 ml, 250 mg/5 ml, and
375 mg/5 ml, Rx antibiotic.
Recall #D-148/151-7.
CODE All lots within expiration date.
MANUFACTURER Lederle Laboratories, Pearl River, New York.
RECALLED BY Wyeth-Ayerst Laboratories, St. Davids,
Pennsylvania, by letter dated February 19,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,433,816 bottles were distributed.
REASON Bulk Cefaclor was recalled by Roussel
Corporation (parent firm of Biochimica Opos)
due to AADA discrepancies regarding the
manufacturing process; AADA was withdrawn.
_______________
PRODUCT Lederle brand Clindamycin Phosphate Injection,
a prescription drug given intramuscularly or
intravenously for the treatment of serious
infections caused by susceptible anaerobic
bacteria: (a) 2 ml; (b) 4 ml; (c) 6 ml; (d) 60
ml vials. Recall #D-152/155-7.
CODE Lot numbers: (a) 409 835 (EXP 2/97), 409 836
(EXP 2/97), 411 803 (EXP 5/97), 417 827 (EXP
6/97); (b) 409 837 (EXP 2/97), 409 838 (EXP
2/97), 411 804 (EXP 2/97), 413 817 (EXP 6/97),
413 818 (EXP 6/97), 417 828 (EXP 6/97), 417 829
(EXP 6/97), 417 830 (EXP 7/97)
(c) 409 834 (EXP 2/97), 411 801 (EXP 2/97)
411 802 (EXP 6/97), 413 816 (EXP 6/97)
417 825 (EXP 6/97), 417 826 (EXP 7/97)
418 267 (EXP 7/97),
(d) 387 801 (EXP 2/97), 411 800 (EXP 7/97) 413
815 (EXP 7/97).
MANUFACTURER Lederle Parenterals, Inc., Carolina, Puerto
Rico.
RECALLED BY Wyeth Ayerst Laboratories, St. Davids,
Pennsylvania, by letter dated February 19,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 300,389 vials were distributed.
-9-REASON Bulk Clindamycin was recalled by Roussel
Corporation (parent firm of Biochimica Opos)
due to AADA discrepancies regarding the
manufacturing process; AADA was withdrawn.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Gastrografin (Diatrizoate Meglumine 660 mg/ml
and Diatrizoate Sodium, 100 mg/ml Solution,
USP), Oral/Rectal Solution in 120 ml bottles a
prescription iodinated radiopaque contrast
medium. Recall #D-144-7.
CODE Lot #ML015 EXP 11/00.
MANUFACTURER Bristol-Myers Squibb Company, Bristol-Myers
Squibb U.S. Pharmaceutical and Mead Johnson
Nutritional Group, Evansville, Indiana.
RECALLED BY Bracco Diagnostics, Inc., Princeton, New
Jersey, by letter on February 18, 1997. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 36,012 4-ounce bottles in 3,001 cases of 12
bottles each.
REASON Presence of foreign substance (small rubber
particles from filling machine seal found in
several units).
_______________
PRODUCT Transderm-Nitro (Transdermal Nitroglycerin) 100
mg (0.8 mg/hour), Rx, institutional use only,
indicated for the prevention of angina
pectoris. Recall #D-145-7.
CODE Lot #C9080 EXP 8/97.
MANUFACTURER Reservoir: Ciba Pharmaceuticals Division (Old
Name at time of Manufacturing)
Ciba-Geigy Corporation, Summit, New Jersey;
System Fabrication: Ivers-Lee (now
Sharp/Ivers-Lee) West Caldwell, New Jersey.
RECALLED BY Novartis (formerly Ciba) Pharmaceuticals
Corporation, Summit, New Jersey, by letter
February 20, 1997, followed by telephone.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 774 cartons (30 systems per carton) were
distributed.
REASON Product lacks stability (failed content assay
after two years-- Spec is 85-ll0mg/system,
found as low as 80%)
-10-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Source Plasma. Recall #B-558-7.
CODE Unit numbers: EUP416, EUP431, EUP444, EUP458,
EUP472, EUP497, HVM413, HVM426, HVM438, HVM461,
HVM472, HVM522, HVM577, HVM616, HVM631, HVM644,
HVM674, HVM687, HVM702, HVM732, HVM744,
HVM757, HVM766, HVN070, HVN084, HVN092, HVN105,
HVN118, HVN128, HVN138, HVN149, HVN175, HVN191,
HVN204, HVN217.
MANUFACTURER Plasma Services of Montana, Billings, Montana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated April 17, 1994. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 35 units were distributed.
REASON Blood products tested negative for the antibody
to the human immunodeficiency virus type 1
(anti-HIV-1), but were collected from a donor
who previously tested Western blot
indeterminate.
_______________
PRODUCT Source Plasma. Recall #B-559-7.
CODE Unit numbers: EUP284, EUP297, EUP313, EUP328,
EUP348, EUP359, EUP370, EUP383, EUP395, EUP406,
EUP419, EUP446, EUP460, EUP474, EUP484, EUP499,
HVM415, HVM427, HVM440, HVM352, HVM462,
HVM473, HVM482, HVM494, HVM511, HVM524, HVM579,
HVM594, HVM618, HVM633, HVM646, HVM657, HVM676,
HVM689, HVM704, HVM711, HVM720, HVM734, HVM746,
HVM755, HVM768, HVM783, HVM794, HVM809, HVM822,
HVM835, HVM852, HVM908, HVM919, HVM934, HVM946,
HVM962, HVM976, HVM991, HVN007, HVN030,
HVN059, HVN072, HVN086, HVN094, HVN107, HVN120,
HVN130, HVN140, HVN151, HVN165, HVN177, HVN193,
HVN206, HVN219, HVN232.
MANUFACTURER Plasma Services of Montana, Billings, Montana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated April 19, 1994. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 71 units were distributed.
REASON Blood products tested negative for the antibody
to the human immunodeficiency virus type 1
(anti-HIV-1), but were collected from a donor
who previously tested Western blot
indeterminate.
-11-_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-567/568-7.
CODE Unit #5721198.
MANUFACTURER Oklahoma Blood Institute, Oklahoma City,
Oklahoma.
RECALLED BY Manufacturer, by fax and telephone on November
28 and 29, 1995. Firm-initiated recall
complete.
Distribution Massachusetts and New York.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
reported a diagnosis of cancer.
_______________
PRODUCT Red Blood Cells. Recall #B-570-7.
CODE Unit #38FE17220.
MANUFACTURER American Red Cross Blood Services, Fort Wayne,
Indiana.
RECALLED BY Manufacturer, by telephone on October 8, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported travel to an area considered endemic
for malaria.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; รพ Recovered
Plasma. Recall #B-575/577-7.
CODE Unit #13FN05688.
MANUFACTURER American Red Cross Blood Services, Detroit,
Michigan.
RECALLED BY Manufacturer, by letter dated October 16, 1996.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
taking the drug Proscar.
_______________
PRODUCT Blood Storage Freezers, 20 cubic feet chest
units and 13 cubic feet upright unit.
Recall #B-592-7.
Code Brand Model Number Serial Number
Baxter RC2090A12 3l5l82
Baxter RCUl386Al4 3l8792
Jewett LTUR-13V14 314749
Revco UFRC1386-5-A12 316149
Revco UFRC1386-7-A14 320399.
MANUFACTURER Revco Lindberg, Ashville, North Carolina.
-12-RECALLED BY Manufacturer, by telephone followed by fax the
week of March 3, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Arizona, California, Iowa, Chile, Honduras.
QUANTITY 5 units were distributed.
REASON Blood storage freezers have failing/defective
compressors.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT Red Blood Cells. Recall #B-551-7.
CODE Unit numbers: 12FQ39762, 12FQ39735, 12LF47760,
12LF47758, 12LE46283, 12LE46280, 12LW21408,
12LW21409, 12FN21077, 12FN21075, 12FN21028,
12FN21074, 12FN21099, 12FN21088, 12FN21085,
12FN21092.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by telephone on December 30 and
31, 1996, January 1 and 30, 1997. Firm-
initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 16 units were distributed.
REASON Blood products may have been exposed to
unacceptable shipping temperatures.
_______________
PRODUCT Platelets, Pheresis. Recall #B-557-7.
CODE Unit numbers 10000468 and 10000470.
MANUFACTURER W.E. and Lela I. Stewart Blood Center, Inc.,
Tyler, Texas.
RECALLED BY Manufacturer, by letter dated January 17 or 28,
1997. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 2 units were distributed.
REASON Blood products were incorrectly tested for the
antibody to the human immunodeficiency virus
types 1 and 2 (anti-HIV-1/2).
_______________
PRODUCT Abbott HIVAG-1 Monoclonal EIA Kit, Antibody to
Human Immunodeficiency Virus Type 1 (HIV-1).
Recall #B-563-7.
CODE Masterlots to be destroyed: 20387M401,
20388M401, 21204M201, 21205M201, 21259M101,
21260M101, 21375M401, 21376M401, 21453M301,
21454M301, 21456M301, 21673M201, 21674M201,
22043M201, 22182M401, 22371M101, 22383M301,
22384M301, 23087M401, 23088M401, 23286M401,
23287M401, 23812M101, 24035M201, 24560M401,
25006M401, 25491M101
-13- Masterlots to be relabeled with new expiration
dates:
22181M401 25345M301 23705M201 25347M301
23821M101 25770M201 24077M401 25778M201
24476M301 25780M201 24495M201 26268M101
24529M201 26425M101 24681M301 26706M201.
MANUFACTURER Abbott Laboratories, Diagnostic Division,
Abbott Park, Illinois.
RECALLED BY Manufacturer, by letter on March 31, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 5,632 - 100 test kits and 7,813 - 1000 test
kits were distributed.
REASON HIVAG-1 Monoclonal masterlots does not
consistently meet the Positive Control validity
requirement through the currently labeled
expiration dating.
_______________
PRODUCT Red Blood Cells. Recall #B-569-7.
CODE Unit #23132-1171.
MANUFACTURER United Blood Services, Billings, Montana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated October 9, 1996. Firm-initiated
recall complete.
DISTRIBUTION Montana.
QUANTITY 1 unit was distributed.
REASON Blood product remained at room temperature for
more than 30 minutes.
_______________
PRODUCT Red Blood Cells. Recall #B-578-7.
CODE Unit numbers: 12419-2389, 12418-7597, 12418-
7596, 12418-7595, 12418-7594, 12418-7593,
12418-7592, 12418-7591, 12418-7590, 12418-7589,
12418-7588.
MANUFACTURER United Blood Services, Albuquerque, New Mexico.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on September 11, 1996. Firm-
initiated recall complete.
DISTRIBUTION New Mexico.
QUANTITY 11 units were distributed.
REASON Blood products were prepared from units of
whole blood that were exposed to temperatures
exceeding 10 degrees C.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =========
_______________
PRODUCT Baxter InterLink System T-Connector Extension
Sets with Luer Slip Adapters,
(a) Catalog No. 2N3326, InterLinkR System
T-Connector Extension Set
-14- (b) Catalog No. 2N3329, InterLinkR System
T-Connector Extension Set
(c) Catalog No. 2N3330, InterLinkR System Dual
Line T-Connector Extension Set
(d) Catalog No. 2N3332, InterLinkR System
T-Connector Extension Set, 0.22 Micron Filter
(e) Catalog No. 3C0007, InterLinkR System
Continu-Flo Solution Set, 3-Way Stopcock,
T-Connector Extension Set
(f) Catalog No. 3C0026, InterLinkR System
BuretrolR Solution Set, Extension Set, 3-Way
Stopcock, T-Connector Extension Set
(g) Catalog No. 3C0028, InterLinkR System
Continu-FloR Solution Set, 3-Way Stopcock,
T-Connector Extension Set
(h) Catalog No. 3C0047, InterLinkR System 4-Way
Large Bore Stopcock Extension Set, T-Connector
Extension Set
(i) Catalog No. 3C0050, InterLinkR System
Continu-FloR Set, Three 4-Way Stopcocks
Extension Set, T-Connector Extension Set
(j) Catalog No. 1C8567, InterLinkR System
Extension Set, T-Connector Set
(k) Catalog No. 1C8571, InterLinkR System
Extension Set, T-Connector.
Recall #Z-408/418-7.
CODE All lots.
MANUFACTURER Baxter Healthcare Corporation, Aibonito, Puerto
Rico and Cleveland, Mississippi.
RECALLED BY Baxter Healthcare Corporation, Round Lake,
Illinois, by letter dated March 14, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 4,990,004 sets were distributed; firm estimated
that 5 percent remained on market at time of
recall initiation.
REASON The luer slip adapter of the InterLinkR
T-Connector Extension Set may inadvertently
disconnect from mated connections.
_______________
PRODUCT Chocolate II Agar Plates, for in-vitro
diagnostic use, Catalog Nos. 4321169 & 4321267.
Recall #Z-423-7.
CODE Lot Nos. A3RTWG, A3RTWZ, A3RTXJ, A3RTXNK,
A3RTYB, A4RTZZ, A4RUAA, A4RUAN, A4RUAR, A4RUBN,
A4RUGF, BIRUGU, BIRUGU, BIRUHJ, B2RUJZ, B2RUKR,
B2RULM, B2RULL, B2RUMF, B3RUMI, B3RUNB, B3RUNX,
B3RUOL, B3RUPA, B3RUPO, B3RUPB, B3RUPX, B3RUPP,
B3RUPZ, B4RUST, B4RUTM, B4RUUA, B4RUWA, C2RUYW,
C2RUZS, C3RWBI, C3RWCH, C3RWCZ, C3RWGN,
-15- C4RWHB, C4RWHX, C4RWIR, C4MWJF, C4RWJG, C4RWIZ,
C4RWJU, C5RWKK, C5RWLC, C5MWNH, C5RWLX, C5RWMI,
C5RWMJ.
MANUFACTURER Becton Dickinson Microbiology Systems,
Cockeysville, Maryland.
RECALLED BY Manufacturer, by letter dated January 21, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 4,026,980 units were distributed.
REASON There was decreased growth of QC organism
Haemophilus Influenzae.
_______________
PRODUCT Abbott IMx & AxSYM PSA (Prostate Specific
Antigen) Reagent Packs, for in-vitro diagnostic
use:
(a) IMx Kit, Catalog No. 2245-20,
(b) AxSYM Kit, Catalog No. 7A49-20.
Recall #Z-424/425-7.
CODE Lot Numbers: (a) 25102Q100, 25104Q100,
25107Q100, 26646Q100, 23569Q100, 25103Q100
(b) 23523Q100, 23523Q101, 23535Q100,
23535Q101, 23547Q100, 24236Q100, 24236Q101,
24239Q100, 25245Q100, 25246Q100, 25293Q100,
25414Q100, 25415Q100, 25440Q100, 25441Q100,
25441Q101, 25442Q100, 25442Q101, 25443Q100,
25443Q101.
MANUFACTURER Abbott Health Products, Inc., Barceloneta,
Puerto Rico.
RECALLED BY Abbott Laboratories, Diagnostic Division,
Abbott Park, Illinois, by telephone on March
20, 1997, followed by letter. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 14,244 packs; (b) 28,138 packs were
distributed; firm estimated that 50 percent of
product remained on market at time of recall
initiation.
REASON The kits give falsely elevated PSA values with
samples from patients who have undergone
radical prostatectomies.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Simon Nitinol Filter Set, indicated for use in
the prevention of recurrent pulmonary embolism
via placement in the vena cava via a
jugular/femoral approach. Recall #Z-426-7.
CODE Catalog #2220J, Lot #509126D.
MANUFACTURER Nitinol Medical Technologies, Inc., Boston,
Massachusetts.
-16-RECALLED BY Manufacturer, by letter of March 5, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Alabama, New Jersey, Ohio, Pennsylvania.
QUANTITY 7 units were distributed.
REASON The outer box label indicated catalog no. 2120F
(Femoral), which is incorrect while the inner
pouch was labeled 2220J (Jugular) which is
correct.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II ===========
_______________
PRODUCT Nutrena Super 20 Dairy Pellets (non-medicated).
Recall #V-035-7.
CODE None.
MANUFACTURER Cargill Nutrena Feed, Wilson, North Carolina.
RECALLED BY Cargill Animal Nutrition Division, Wayzata,
Minnesota, by telephone on February 10, 1997.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 46,830 pounds were distributed.
REASON The Nutrena Super 20 Dairy Pellets
(non-medicated) were loaded onto a truck
containing a swine feed medicated with
chlortetracycline, sulfamethazine and
penicillin (ASP) and delivered to two dairies
as a non-medicated feed.
-17-
END OF ENFORCEMENT REPORT FOR April 16, 1997. BLANK PAGES MAY FOLLOW.
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