Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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January 11, 2006
06-02

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

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PRODUCT
Worthington brand Vegetarian Choplets, packed in Net Wt 1lb. 4 oz. cans, UPC Code - 28989 22503, Recall # F-046-6
CODE
Cans with a code beginning with "06085 CS L" stamped on the bottom of the can.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kellogg Sales Co, Battle Creek, MI, by press release on October 28, 2005.
Manufacturer: Castleberrys Food Company, Augusta, GA. Firm initiated recall is complete.
REASON
Some cans actually contain Veja-Links, which contain egg and milk, but these ingredients are not included in the Choplets ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
6048 cans
DISTRIBUTION
AZ, CA, CO, KS, MO, NY, OH, OR and WA

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PRODUCT
a) Home Style Salad Selection Golden
Taste brand Tuna Deluxe, Net Wt.
3.5 oz., 7.5 oz., and 5 lb. The
product is packaged in a rigid
plastic container. UPC barcode
# 7 58259 77115 7, Recall # F-047-6;
b) Home Style Salad Selection Golden
Taste brand Scallion Tuna Deluxe,
Net Wt. 3.5 oz., 7.5 oz., and 5 lbs.
The product is packaged in a rigid
plastic container, UPC barcode #
7 58259 77174 4, Recall # F-048-6;
c) Home Style Salad Selection Golden
Taste brand White Fish Salad, Net Wt.
3.5 oz., 7.5 oz., and 5 lb. The
product is packaged in a rigid
plastic container, Recall # F-049-6;
d) Home Style Salad Selection Golden
Taste brand Baked Salmon Salad,
Net Wt. 3.5 oz., 7.5 oz., and 5 lb.
The product is packaged in a rigid
plastic container, UPC barcode #
7 58259 77161 4, Recall # F-050-6
CODE
a) Date codes 7/24/05 & 8/01/05;
b) Date codes 7/05/05 & 7/12/05;
c) Date code 7/14/05;
d) Date code 8/11/05
RECALLING FIRM/MANUFACTURER
Golden Taste, Inc., Spring Valley, NY, by press release and letters dated June 28, 2005 and by press release and letters dated July 7, 2005. Firm initiated recall is complete.
REASON
The products were found to be contaminated with Listeria monocytogenes based on routine samplings & analyses by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
a) 3.5 oz: 400 tubs, 7.5 oz.: 500 tubs,
5 lbs.: 40 tubs;
b) 3.5 oz.: 300 tubs, 7.5 oz: 475 tubs,
5 lbs.: unknown;
c) Unknown;
d) Unknown
DISTRIBUTION
NY and NJ

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

CORRECTIONS

The December 28, 2005 -- 05-52 Enforcement Report, Recall # D-057-6 Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared from Fission Produced Molybdenum 99, Lot number 5179, Exp. 11/23/05, was incorrectly associated with Catalog numbers N8891L, 2L and N8891T, 2T (5.0 curies).

_______________________________
PRODUCT
a) Ultra-TechneKow DTE, UTK-DTE, Technetium
Tc 99m Generator, Parent Molybdenum 99
prepared from Fission Produced Molybdenum
99, Catalog number N8831L (1.0 curie).
Recall # D-051-6;
b) Ultra-TechneKow DTE, UTK-DTE,
Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared
from Fission Produced Molybdenum
99, Catalog number N8841L (1.5
curies). Recall # D-052-6;
c) Ultra-TechneKow DTE, UTK-DTE,
Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared
from Fission Produced Molybdenum
99, Catalog number N8851L , 2L
(2.0 curies). Recall # D-053-6;
d) Ultra-TechneKow DTE, UTK-DTE,
Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared
from Fission Produced Molybdenum
99, Catalog number N8861L, 2L
(2.5 curies). Recall # D-054-6;
e) Ultra-TechneKow DTE, UTK-DTE,
Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99,
Catalog number N8871L, 2L (3.0
curies). Recall # D-055-6;
f) Ultra-TechneKow DTE, UTK-DTE,
Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared from
Fission Produced Molybdenum 99,
Catalog number N8881L, 2L (3.5
curies). Recall # D-056-6;
g) Ultra-TechneKow DTE, UTK-DTE,
Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared from
Fission Produced Molybdenum 99,
Catalog numbers N8891L, 2L and
N8891T, 2T (5.0 curies).
Recall # D-057-6;
h) Ultra-TechneKow DTE, UTK-DTE,
Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared
from Fission Produced Molybdenum
99, Catalog numbers N8901L, 2L,
and N8901T, 2T (6.0 curies),
Recall # D-058-6;
i) Ultra-TechneKow DTE, UTK-DTE,
Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99,
Catalog numbers N8911L, 2L,
and N8911T, 2T (7.5 curies),
Recall # D-059-6;
j) Ultra-TechneKow DTE, UTK-DTE,
Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99,
Catalog number N8921D, 2D (11.0 curie).
Recall # D-060-6;
k) Ultra-TechneKow DTE, UTK-DTE,
Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared from
Fission Produced Molybdenum 99,
Catalog number N8931D, 2D (14.0
curie), Recall # D-061-6;
l) Ultra-TechneKow DTE, UTK-DTE,
Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99,
Catalog number N8941D, 2D (16.0
curie). Recall # D-062-6;
m) Ultra-TechneKow DTE, UTK-DTE,
Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared
from Fission Produced Molybdenum 99,
Catalog number N8951D, 2D (19.0
curie). Recall # D-063-6
CODE
a) Lot 5176, Exp. 11/18/05;
Lot 5178, Exp. 11/21/05;
Lot 5180, Exp. 11/25/05;
Lot 5182, Exp. 11/28/05;
b) Lot 5176, Exp. 11/18/05;
Lot 5180, Exp. 11/25/05;
c) Lot 5176, Exp. 11/18/05;
Lot 5178, Exp. 11/21/05;
Lot 5179, Exp. 11/23/05;
Lot 5180, Exp. 11/25/05;
Lot 5182, Exp. 11/28/05;
d) Lot 5176, Exp. 11/18/05;
Lot 5178, Exp. 11/21/05;
Lot 5179, Exp. 11/23/05;
Lot 5180, Exp. 11/25/05;
Lot 5182, Exp. 11/28/05;
e) Lot 5176, Exp. 11/18/05;
Lot 5178, Exp. 11/21/05;
Lot 5179, Exp. 11/23/05;
Lot 5180, Exp. 11/25/05;
Lot 5182, Exp. 11/28/05;
f) Lot 5176, Exp. 11/18/05;
Lot 5178, Exp. 11/21/05;
Lot 5179, Exp. 11/23/05;
Lot 5180, Exp. 11/25/05;
Lot 5182, Exp. 11/28/05;
g) Lot 5176, Exp. 11/18/05;
Lot 5178, Exp. 11/21/05;
Lot 5180, Exp. 11/25/05;
Lot 5182, Exp. 11/28/05;
h) Lot 5176, Exp. 11/18/05;
Lot 5179, Exp. 11/23/05;
Lot 5180, Exp. 11/25/05;
i) Lot 5176, Exp. 11/18/05;
Lot 5177, Exp. 11/20/05;
Lot 5178, Exp. 11/21/05;
Lot 5179, Exp. 11/23/05;
Lot 5180, Exp. 11/25/05;
Lot 5181, Exp. 11/27/05;
Lot 5182, Exp. 11/28/05;
j) Lot 5176, Exp. 11/18/05;
Lot 5177, Exp. 11/20/05;
Lot 5178, Exp. 11/21/05;
Lot 5179, Exp. 11/23/05;
Lot 5180, Exp. 11/25/05;
Lot 5181, Exp. 11/27/05;
Lot 5182, Exp. 11/28/05;
k) Lot 5176, Exp. 11/18/05;
Lot 5177, Exp. 11/20/05;
Lot 5178, Exp. 11/21/05;
Lot 5179, Exp. 11/23/05;
Lot 5180, Exp. 11/25/05;
Lot 5181, Exp. 11/27/05;
Lot 5182, Exp. 11/28/05;
l) Lot 5176, Exp. 11/18/05;
Lot 5177, Exp. 11/20/05;
Lot 5178, Exp. 11/21/05;
Lot 5179, Exp. 11/23/05;
Lot 5180, Exp. 11/25/05;
Lot 5181, Exp. 11/27/05;
Lot 5182, Exp. 11/28/05;
m) Lot 5176, Exp. 11/18/05;
Lot 5177, Exp. 11/20/05;
Lot 5178, Exp. 11/21/05;
Lot 5179, Exp. 11/23/05;
Lot 5180, Exp. 11/25/05;
Lot 5181, Exp. 11/27/05;
Lot 5182, Exp. 11/28/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mallinckrodt Inc, Berkeley, MO, by letters on November 18, and November 22, 2005.
Manufacturer: Mallinckrodt Inc, Maryland Heights, MO. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility: Positive unit found in a media fill run.
VOLUME OF PRODUCT IN COMMERCE
1,646 generators
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Children's Motrin Bubblegum Suspension 4 oz bottle, Ibuprofen 100 mg/5ml, OTC, NDC 50580-604-04, Recall # D-081-6
CODE
Lot number HHM187 exp 8/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Presence of particulate matter: product intended for destruction due to white fiber material found on packaging transfer screen was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

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PRODUCT
Simply Sleep Mini-Caplets, (Diphenhydramine HCl) 25mg, 100 mini-caplets per bottle, NDC 50580-843-10, Recall # D-083-6
CODE
Lot number JFM058 exp 5/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Presence of particulate matter: product intended for destruction due to white fiber material found on packaging transfer screen was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

_______________________________
PRODUCT
Tylenol Sinus Nighttime Caplets, Each caplet contains Acetaminophen 500 mg, Doxylamine succinate 6.25 mg, Pseudoephedrine HCl 30 mg, 12 count blister card packages, Recall # D-084-6
CODE
Lot number JMM087 exp 7/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Mispacked; product intended for destruction due to foreign object (ball bearing) found in blister card was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

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PRODUCT
Children's Tylenol Soft-Chews, (Acetaminophen), 80 mg, 30 tablet bottle, Fruit Flavor, NDC 50580-105-32, Recall # D-089-6
CODE
Lot number HPM102 exp 8/05
RECALLING FIRM/MANUFACTURER
McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is complete.
REASON
Label error on declared strength; quantity for other ingredient phenylalanine is listed as 3 mg instead of as 6mg (product intended for destruction was possibly diverted to retail stores).
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Children's Tylenol Oral Suspension,
(Acetaminophen), 160 mg/5mL (teaspoon),
4 Fl oz (120mL), bottles, Bubblegum Yum
Flavor, NDC 50580-407-04, Recall # D-090-6;
b) Children's Tylenol Oral Suspension,
(Acetaminophen), 160 mg/5mL (teaspoon),
4 Fl oz (120mL), bottles, Cherry Blast
Flavor, NDC 50580-123-04, Recall # D-091-6
CODE
a) Lot numbers: JLM121 exp 9/06,
and JLM122 exp 9/06;
b) JLM123 exp 9/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Presence of foreign substance; pieces of wire tie found, product intended for destruction was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Prochlorperazine Edisylate Injection
USP 10 mg/2 mL (5 mg/ml) in 2 ml
vials. The product is shipped in
shippers that contain 40 cartons
and cartons contain 25 vials,
Rx only, NDC 0703-7171-04,
Recall # D-092-6;
b) Prochlorperazine Edisylate Injection
USP 5 mg/ml in 10 ml vials. The
product is shipped 1 vial per carton,
Rx only, NDC 0703-7175-01,
Recall # D-093-6
CODE
a) Lot numbers: 03P138, 04A118, 04A125,
04D101, 04D102, 04D111, and 04D129;
b) Lot numbers: 03P115, 04B128, and
04D108
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Sellersville, PA, by letter dated October 13, 2005.
Manufacturer: Sicor Pharmaceuticals, Inc, Irvine, CA, Firm initiated recall is ongoing.
REASON
Presence of particulate matter.
VOLUME OF PRODUCT IN COMMERCE
733,972 vials
DISTRIBUTION
Nationwide

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PRODUCT
Children's Tylenol Flu Suspension 4 oz bottle. Acetaminophen (APAP) 160 mg, chlorpheniramine maleate (CPM) 1 mg, dextromethorphan HBr (DXM) 7.5 mg, pseudoephedrine HCl (PSE) 15 mg per 5 ml suspension, OTC, Recall # D-094-6
CODE
Lot number JAM149 exp. 01/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA, by letter on September 19, 2005. Firm initiated recall is ongoing.
REASON
Presence of particulate matter: Product intended for destruction due to a small piece of black foreign material observed on the packaging screen was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

_______________________________
PRODUCT
Children's Tylenol Plus Flu Suspension Bubblegum Flavor 4 oz. Acetaminophen 160 mg per 5 ml, chlorpheniramine maleate 1 mg per 5 ml, dextromethorphan HBr 7.5 mg per 5 ml, and pseudophedrine HCl 15 mg per 5 ml, OTC, NDC 50580-202-04, Recall # D-095-6
CODE
Lot number JAM217 exp 2/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA, by letter on September 19, 2005. Firm initiated recall is ongoing.
REASON
Presence of particulate matter: product intended for destruction due to wood found on mesh screen was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

_______________________________
PRODUCT
Tylenol Arthritis Extended Relief Caplets 100 count bottles. Each caplet contains acetaminophen 650 mg, OTC, NDC 50580-112-10, Recall # D-096-6
CODE
Lot number HAM149 exp 1/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA, by letter on September 19, 2005. Firm initiated recall is ongoing.
REASON
Presence of particulate matter: product intended for destruction due to the possibility of broken metal pieces from the compression punches being compressed in the caplets was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

_______________________________
PRODUCT
Tylenol Arthritis Extended Relief Caplets 100 count bottles. Each caplet contains acetaminophen 650 mg, OTC, Recall # D-097-6
CODE
Lot number HAM086 exp 12/05
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA, by letter on September 19, 2005. Firm initiated recall is complete.
REASON
Presence of particulate matter: product intended for destruction due to the possibility of broken metal pieces from the compression punches being compressed in the caplets was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

_______________________________
PRODUCT
Temazepam, USP, 15 mg. capsules, Item # 0067687. Rx. NDC 49999-045-15, Recall # D-098-6
CODE
Lot 08406; Exp. 07/31/08.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lake Erie Medical & Surgical, Temperance, MI, by telephone on November 5, 2005.
Manufacturer: Lake Erie Medical & Surgical, Toledo, OH. Firm initiated recall is complete.
REASON
Mislabeling: The product is labeled as 15 mg capsules, but the package actually contains 30 mg capsules.
VOLUME OF PRODUCT IN COMMERCE
6 bottles
DISTRIBUTION
FL

_______________________________
PRODUCT
Infant's Tylenol Concentrated Drops Cherry Flavor 1/2 oz. Acetaminophen 80 mg/0.8 ml, OTC, Recall # D-099-6
CODE
Lot number JMM075 exp 10/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Presence of particulate matter: Product intended for destruction due lint free cloth found in mixer was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

_______________________________
PRODUCT
Mylanta Gelcaps, Each gelcap contains: Calcium carbonate 550 mg and Magnesium hydroxide 125 mg, 50 count Solid Gelcaps bottles, NDC 16837-850-50, Recall D-085-6
CODE
Lot number JEM115 exp 4/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Defective container; missing foil inner seal, product intended for destruction was possibly diverted to retail market.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Infants Tylenol Concentrated Drops Plus Cold, Each 0.8mL contains Acetaminophen 80 mg and Pseudoephedrine HC1 7.5mg, ½ Fl oz (15mL) bottles, NDC 50580-503-15, Recall # D-086-6
CODE
Lot HJM140 exp 9/05
RECALLING FIRM/MANUFACTURER
McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Failed pH specification, product intended for destruction was possibly diverted to retail market.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Tylenol Allergy Sinus Day Time Gelcaps, Each gelcap contains Acetaminophen 500 mg, Chlorpheniramine maleate 2 mg, and Pseudoephedrine HC1 30 mg, Maximum Strength, 48 count blister pack, Recall # D-087-6
CODE
Lot HFM048 exp 6/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Defective packaging; damage blister card inspection, product intended for destruction was possibly diverted to retail market.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Children's Motrin Oral Suspension, (Ibuprofen), 100 mg/5 ml (teaspoon), 4 Fl oz (120mL) bottles, Original Berry Flavor, NDC 50580-601-04, Recall # D-088-6
CODE
Lot HCM001 exp 1/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Subpotent (product intended for destruction was possibly diverted to retail stores).
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Tylenol Allergy Sinus gelcap. Each caplet contains acetaminophen 500 mg, chlorpheniramine maleate 2 mg, and pseudoephedrine HCl 30 mg, OTC, Recall # D-100-6
CODE
Lot number JMM180 exp 7/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer and Specialty Pharmaceuticals, Division of McNeil PPC, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is complete.
REASON
Defective container: product intended for destruction due a tear in the pouch was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

_______________________________
PRODUCT
a) Fougera TRIAMCINOLONE ACETONIDE
LOTION USP, 0.1%, 60 mL,
NDC 0168-0337-60, FOR DERMATOLOGIC
USE NOT FOR OPHTHALMIC USE, Rx only,
Recall # D-101-6;
b) Fougera TRIAMCINOLONE ACETONIDE
LOTION USP, 0.025%, 60 mL,
NDC 0168-0336-60, FOR DERMATOLOGIC
USE NOT FOR OPHTHALMIC USE, Rx only,
Recall # D-102-6;
c) Fougera FLUOCINOLONE ACETONIDE TOPICAL
SOLUTION USP, 0.01%, 60 mL,
NDC 0168-0059-60, FOR DERMATOLOGIC
USE ONLY NOT FOR OPHTHALMIC USE,
Rx only, Recall # D-103-6;
d) Fougera CLOBETASOL PROPIONATE TOPICAL
SOLUTION USP, 0.05%, 50 mL,
NDC 0168-0269-50, FOR USE ON THE SCALP
FOR DERMATOLOGIC USE ONLY NOT FOR
OPHTHALMIC USE, Rx only,
Recall # D-104-6
e) Fougera BETAMETHASONE VALERATE
LOTION USP, 0.1% (Potency expressed
as betamethasone), 60 mL,
NDC 0168-0041-60, FOR DERMATOLOGIC
USE ONLY NOT FOR OPHTHALMIC USE,
Rx only, Recall # D-105-6;
f) Fougera BETAMETHASONE DIPROPIONATE
LOTION USP, 0.05% (Potency expressed
as betamethasone), 60 mL,
NDC 0168-0057-60, FOR DERMATOLOGIC
USE ONLY NOT FOR OPHTHALMIC USE,
Rx only, Recall # D-106-6
CODE
a) Lot T431, exp. 8/07;
b) Lot S999, exp. 8/07;
c) Lot T600, exp. 4/07;
d) Lot T610, exp. 3/07;
Lot T611, exp. 3/07;
e) Lot T480, exp. 9/08;
Lot T481, exp. 9/08;
f) Lot T469, exp. 9/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Altana Inc., Melville, NY, by telephone, fax and e-mail beginning on December 15, 2005.
Manufacturer: Altana Inc., Hicksville, NY. Firm initiated recall is ongoing.
REASON
Defective Dropper: The dropper plug does not meet specification in that the container/closure component cannot ensure an adequate opening for dispensing the drug product.
VOLUME OF PRODUCT IN COMMERCE
66,692 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0475-6;
b) Platelets, Recall # B-0476-6
CODE
a) and b) Unit number: 0119589
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter dated July 5, 2005. Firm initiated recall is complete.
REASON
Blood products, associated with a unit of Fresh Frozen Plasma that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0479-6;
b) Platelets Pheresis, Leukocytes
Reduced, Recall # B-0480-6
CODE
a) Unit number: 21KL69575;
b) Unit numbers: 21KP55627 (split unit),
21KP53522, 21KP51485
RECALLING FIRM/MANUFACTURER
American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on March 8, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
OR

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_______________________________
PRODUCT
a) Baxter Interlink System Non-DEHP
Y-Type Catheter Extension Set,
product code 2N3371; An Rx sterile,
nonpyrogenic fluid pathway, 5.7",
0.8 mL Vol., with 2 injection
sites and a male Luer Lock adapter,
Recall # Z-1424-05;
b) Baxter Minivolume Extension Set, 72",
product code 2C5687; An Rx sterile,
nonpyrogenic fluid pathway, 72",
1.6 mL Vol., with a male Luer Lock
adapter; Recall # Z-1425-05;
c) Baxter Minivolume Extension Set,
36", product code 2C5685; An Rx
sterile, nonpyrogenic fluid pathway,
36", 0.9 mL Vol., with a male Luer
Lock adapter, Recall # Z-1426-05;
d) Baxter Mini-Infuser Microbore
Extension Set, product code 2C9201;
An Rx sterile, nonpyrogenic fluid
pathway, 61", 0.5 mL Vol., with Luer
Lock adapters, Recall # Z-1427-05;
e) Baxter Tamper Resistant Anti-Siphon
PCA Extension Set, 60", product code
2C9205; An Rx sterile, nonpyrogenic
fluid pathway, 60", 1.2 mL Vol.,
with Luer Lock adapters, Recall #
Z-1428-05;
f) Baxter Tamper Resistant Anti-Siphon
PCA Extension Set, 96", product
code 2C9206; An Rx sterile,
nonpyrogenic fluid pathway, 96",
1.6 mL Vol., with Luer Lock
adapters, Recall # Z-1429-05;
g) Baxter Tamper Resistant Anti-Siphon
Combination Set, 101", product code
2L3507; An Rx sterile, nonpyrogenic
fluid pathway, 101", 2.5 mL Vol.,
with male Luer Lock adapter,
Recall # Z-1430-05;
h) Baxter Extension Set, product code
2C9219; An Rx sterile, nonpyrogenic
fluid pathway, 61", 1.4 mL Vol., with
Luer Lock adapters,
Recall # Z-1431-05;
i) Baxter Interlink System Huber Needle
Extension Set, product code 2N3703;
An Rx sterile, nonpyrogenic fluid
pathway with Needle Gauge 22, Needle
Length ¾", Total Volume 0.40 mL,
Total Length 9", Recall # 1432-05;
j) Baxter Interlink System Huber Needle
Extension Set, product code 2N3706;
An Rx sterile, nonpyrogenic fluid
pathway with Interlink Y-Injection Site,
Needle Gauge 19, Needle Length 3/4",
Total Volume 0.75 mL, Total Length 10",
Recall # Z-1433-05;
k) Baxter Interlink System Huber Needle
Extension Set, product code 2N3707;
An Rx sterile, nonpyrogenic fluid
pathway with Interlink Y-Injection
Site, Needle Gauge 20, Needle Length
¾", Total Volume 0.75 mL, Total
Length 10", Recall # Z-1434-05;
l) Baxter Interlink System Huber Needle
Extension Set, product code 2N3709;
An Rx sterile, nonpyrogenic fluid
pathway with Interlink Y-Injection
Site, Needle Gauge 22, Needle Length
¾", Total Volume 0.75 mL, Total
Length 10", Recall # Z-1435-05;
m) Baxter Interlink System Huber Needle
Extension Set, product code 2N3710;
An Rx sterile, nonpyrogenic fluid
pathway with Interlink Y-Injection
Site, Needle Gauge 19, Needle
Length 1", Total Volume 0.75 mL,
Total Length 10", Recall # Z-1436-05;
n) Baxter Interlink System Huber Needle
Extension Set, product code 2N3712;
An Rx sterile, nonpyrogenic fluid
pathway with Interlink Y-Injection Site,
Needle Gauge 20, Needle Length 1",
Total Volume 0.75 mL, Total Length 10",
Recall # Z-1437-05;
o) Baxter Interlink System Huber Needle
Extension Set, product code 2N3714;
An Rx sterile, nonpyrogenic fluid
pathway with Interlink Y-Injection
Site, Needle Gauge 22, Needle Length 1",
Total Volume 0.70 mL, Total Length 10",
Recall # Z-1438-05;
p) Baxter Interlink System Huber Needle
Extension Set, product code 2N3716;
An Rx sterile, nonpyrogenic fluid
pathway with Interlink Y-Injection
Site, Needle Gauge 19, Needle Length
1-1/2", Total Volume 0.75 mL, Total
Length 10", Recall # Z-1439-05
CODE
a) Lot numbers: UR247189, UR268656,
UR268920, UR270256; extended to
include lot numbers:UR255919 and
UR261560;
b) Lot numbers: UE107920, UE108480,
UE108696, UE108704, UE108977,
UE108985; extended to include
lots UE107680, UE107763, UE108035,
UE108043, UE108050, UE108100,
UE108282, UE108142, UE108233,
UE108399, UE109355, UE109157;
c) Lot numbers: UE107936, UE108019,
UE108712, UE109140; extended to
include lots UE107722, UE108068,
UE108092, UE108209, UE108308,
UE108316, UE108332, UE108381;
d) Lot UR249987; extended to include
lots UR244434, UR260422, UR270702;
e) Lot UR251058, extended to include
lots UR257535, UR267369, UR274811,
UR278069;
f) Lot numbers: UR254185, UR254524,
UR273987; extended to include
lot UR267344;
g) Lot numbers: UR251389, UR272328,
UR272781, UR274704; extended to
include lotsUR245704, UR269290,
UR277616;
h) Lot numbers: UR266387, UR277061,
UR277848; extended to include
Lot numbers UR245662, UR253435,
UR260398, UR255539, UR255992,
UR259721, UR270793, UR280834;
i) Lot numbers: FC04055, FC05013;
extended to include lot FC05026;
j) Lot numbers: FC04057, FC05001,
FC05010, FC05017; extended to
include lot numbers: FC04049,
FC05022, FC05027, FC05032;
k) Lot numbers: FC04053, FC05000,
FC05005, FC05012; extended to
include lot numbers: FC05016,
FC05028;
l) Lot numbers: FC04052, FC04058,
FC04059, FC05006, FC05009; extended
to include lot numbers: FC05018,
FC05023, FC05029;
m) Lot numbers: FC04050, FC05007,
FC05014; extended to include
lots FC05020, FC05024, FC05030;
n) Lot numbers: FC04054, FC05003,
FC05021; extended to include
Lot numbers: FC05015, FC05033;
o) Lot numbers: FC04056, FC05004,
FC05011; extended to include lot
numbers: FC04047, FC04051, FC05025,
FC05031;
p) Lot number: FC05002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated August 3, 2005 and December 15, 2005.
Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibonito, PR. Firm initiated recall is ongoing.
REASON
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
VOLUME OF PRODUCT IN COMMERCE
507,309 sets
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G, Recall # Z-0328-06
CODE
Revision G (instrument not tracked by lot number).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Encore Medical, Lp, Austin, TX, by letter on October 21, 2005.
Manufacturer: Gauthier Biomedical Inc, Grafton, WI. Firm initiated recall is ongoing.
REASON
Detachable T-handles used in hip instrument sets and shoulder instrument sets may fail during shipment or upon initial use because they were incorrectly assembled.
VOLUME OF PRODUCT IN COMMERCE
141 units
DISTRIBUTION
Nationwide, Saudi Arabia, Japan and Germany

______________________________
PRODUCT
a) Size 6 right Foundation
Total Knee System (Catalog
#324-01-106) knee joint replacement,
Recall # Z-0331-06;
b) Size 8 right 3DKnee Non-porous
Baseplates (Catalog #333-02-108)
joint knee replacement,
Recall # Z-0332-06
CODE
a) Lot #426142 and #426132;
b) Lot #434322
RECALLING FIRM/MANUFACTURER
Encore Medical, Lp, Austin, TX, by letter on November 3, 2005. Firm initiated recall is ongoing.
REASON
The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.
VOLUME OF PRODUCT IN COMMERCE
30 total units
DISTRIBUTION
AZ, CA, FL, GA, MO, NJ, OK, SC, SD, TX. and Germany

_______________________________
PRODUCT
3D TOP Ceiling Stand. X-Ray System model number 8773673, Recall # Z-0335-06
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by Customer Service Engineer visit beginning on December 1, 2005.
Manufacturer: Siemens Medical Solutions, Forchheim, Germany. Firm initiated recall is ongoing.
REASON
Screws on the rollers may become loose.
VOLUME OF PRODUCT IN COMMERCE
460 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

_______________________________
PRODUCT
Arthrotek brand Lactoscrew instruments 3.5 mm drill bit, stainless steel; ref. 905585, Recall # Z-0329-06
CODE
Lot numbers: 044250, 134170, 781690, 781700, 838920, 914620 and 914630.
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated November 10, 2005. Firm initiated recall is ongoing.
REASON
The bit may bend or fracture during use.
VOLUME OF PRODUCT IN COMMERCE
46 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Atlantis Anterior Cervical Plate System Screw Driver, Part number 876-482, Recall # Z-0330-06
CODE
Lot numbers: M05J0371, M05E0548
RECALLING FIRM/MANUFACTURER
Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN, by letter dated December 1, 2005. Firm initiated recall is ongoing.
REASON
Screwdriver handle breakage.
VOLUME OF PRODUCT IN COMMERCE
75 units
DISTRIBUTION
IL, IN, MI, CA, Japan, and the Netherlands

_______________________________
PRODUCT
a) Optiflux Series Fresenius Polysulfone
F160NR dialyzer High Flux Catalog
Number: 0500316N, Recall # Z-0333-06;
b) Optiflux Series Fresenius Polysulfone
F180NR dialyzer High Flux Catalog
Number: 0500318N, Recall # Z-0334-06
CODE
a) and b) Lot Number: 5LU319
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Medical Care North America, Lexington, MA, by letter dated November 28, 2005.
Manufacturer: Fresenius Medical Care North America, Ogden, UT. Firm initiated recall is ongoing.
REASON
Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR
VOLUME OF PRODUCT IN COMMERCE
1136 cases
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) McGhan Style 468-380cc Saline-Filled
BIOCELL textured Breast Implants,
Catalog Number: 468-380,
Recall # Z-0336-06;
b) McGhan Style 163-360cc Saline-Filled
BIOCELL textured Breast Implants,
Catalogue Number: 163-360,
Recall # Z-0337-06
CODE
a) Lot# 1121360, Serial# 11567825, 11567826,
11567827, 11567828, 11567829, 11567830,
11567832, 11567833, 11567835, 11567836,
11567838, 11567839, 11567840, 11567841,
11567842, & 11567843;
b) Lot#1121514, Serial# 11567927 & 11567935
RECALLING FIRM/MANUFACTURER
Inamed Corp, Goleta, CA, by telephone and letters on December 14, 2005. Firm initiated recall is ongoing.
REASON
Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these two lots were switched during packaging. As a result, a total of 40 devices were mislabeled.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

_______________________________
PRODUCT
a) Pig Starter-Medicinado, Tilosina/Sufametacina,
100g/ton, Net WT 50 LBS, PIG PLAN
19% Protein, Recall # V-018-6;
b) Broiler Starter-Medicinado***Monensina
90g/ton***Bacitracina 25g/ton***Broiler
Plan***Net WT 50 lbs, Recall # V-019-6
CODE
a) No lot # - Code # is 10582 Pig Starter;
b) Code 10110 (Broiler Starter)
August 9, 2005, August 17, 2005,
and August 25, 2005
RECALLING FIRM/MANUFACTURER
Tender Mills, Inc., Moca, PR, by telephone and by visit. Firm initiated recall is ongoing.
REASON
Manufacturer used expired feed and medication in the production of the Feed.
VOLUME OF PRODUCT IN COMMERCE
188 bags of 50lbs of Pig Feed and 825 bags of 50 lbs. of Chick feed.
DISTRIBUTION
PR

END OF ENFORCEMENT REPORT FOR JANUARY 11, 2006

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