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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May 28, 2008
08-22

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
ZANTAC 75 (Ranitidine) Tablets 75 mg, 1 Tablet (1 dose), Acid Reducer, Recall # D-216-2008
CODE
Lot #A14991, Expiration Date: 12/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boehringer Ingelheim Roxane Inc., Columbus, OH, by letter on May 5, 2008.
Manufacturer: DSM Pharmaceuticals Inc., Greenville, SC. Firm initiated recall is ongoing.
REASON
Exceeded Impurities Specification: (S-oxide)
VOLUME OF PRODUCT IN COMMERCE
2,279,200 tablets
DISTRIBUTION
Nationwide

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PRODUCT
AMIODARONE HCl Injection, 150mg/3mL (50mg/mL), 10 Single Use Vials, FOR IV USE ONLY, MUST BE DILUTED, Rx ONLY, Recall # D-217-2008
CODE
Lot #1156947, Expiration Date: 12/09
RECALLING FIRM/MANUFACTURER
Ben Venue Laboratories Inc, Bedford, OH, by letter on April 21, 2008. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter; vials contained crystallized active ingredient.
VOLUME OF PRODUCT IN COMMERCE
15,327 packs - 10 vials per pack (153,270 vials)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1046-08
CODE
Unit: 3850584
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on November 28, 2006. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of platelets that were implicated in a transfusion reaction and found to be contaminated with Gram positive cocci, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
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PRODUCT
Red Blood Cells (Apheresis), Recall # B-1058-08
CODE
Units: GP89095 (split unit)
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on November 2, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1392-08
CODE
Unit: 019GY69011
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by telephone on January 26, 2007 and by facsimile on February 2, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was taking the medication Coumadin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1393-08
CODE
Unit: 0648701
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center Inc, Jackson, TN, by facsimile on December 10, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1394-08
CODE
Unit: 5826887
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on May 22, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Source Plasma, Recall # B-1395-08
CODE
Units: 0200385980, 0200391808, 0200391390, 0200392074, 0200390847, 0200390677, 0200390264, 0200390079, 0200389601, 0200389287, 0200388863, 0200388548, 0200388114, 0200387849, 0200387428, 0200387107, 0200386687, 0200386254, 0200385980, 0200385359, 0200384955, 0200384652, 0200384231, 0200383928, 0200383572, 0200383302, 0200382994, 0200382759, 0200382431, 0200382127, 0200381843, 0200381393, and 0200381253
RECALLING FIRM/MANUFACTURER
ZLB Plasma, Norman, OK, by facsimile on January 12, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1396-08
CODE
Unit: 72C859748
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by facsimile on October 5, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1397-08
CODE
Unit: 72C510458
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by facsimile on September 25, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1399-08
CODE
Unit: 172060133
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Mcallen, TX, by telephone on March 19, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1400-08
CODE
Units: 10738-2198; 10747-3823
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, dba United Blood Services, Scottsdale, AZ, by letter on June 25, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-1405-08
CODE
Unit: 6218948
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on April 12, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a Red Blood Cell unit that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
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PRODUCT
Cryoprecipitated AHF, Recall # B-1406-08
CODE
Unit: 5126443
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on April 12, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a Red Blood Cell unit that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-1408-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1409-08
CODE
Units: 107371924
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc dba United Blood Services, Scottsdale, AZ, by telephone on March 21, 2003 and by letter dated April 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1410-08
CODE
Unit: 4047833
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter dated December 14, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
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PRODUCT
a) Blood Grouping Reagent Anti-S for Indirect Antiglobulin Test; 3 mL;
Product Code: 723030 (US), Recall # B-1420-08;
b) Anti-S (MNS3) 3 mL; IVD; Product Code: 714103 (CE marked for sale in European
Union), Recall # B-1421-08
CODE
a) Lot numbers: SS188C; SS188D; SS189A; SS189B; SS189C;
b) Lot numbers: SS188CX, SS188DX, SS189AX, SS189BX
RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics Inc, Raritan, NJ, by letters on April 21, 2008. Firm initiated recall is ongoing.
REASON
Reports of weakened activity or false negative reactions when using these lots of Blood Grouping Reagent Anti-S for Indirect Antiglobulin Test.
VOLUME OF PRODUCT IN COMMERCE
3,692 kits
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1401-08
CODE
Units: 200408310; 200410682 Part 1; 200410682 Part 2
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Mcallen, TX, by telephone and facsimile on July, 20, 2007. Firm initiated recall is complete.
REASON
Blood products, which were in transit for greater than 24 hours and were possibly exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
a) Synchron LX20 Clinical Chemistry System, Part Numbers: 466200,473032,
    Recall # Z-1094-2008;
b) Synchron LX20 PRO, Part Number 476100, Recall # Z-1095-2008;
c) Synchron LXi 725, Part Number A08357, Recall # Z-1096-2008;
d) UniCel DxC 600 Part Number: A10405, Recall # Z-1097-2008;
e) UniCel DxC 600i, Part Numbers: A25638, A25639, Recall # Z-1098-2008;
f) UniCel DxC 600 PRO Part Number: A10400, Recall # Z-1099-2008;
g) UniCel DxC 800 Part Number: A10411, Recall # Z-1100-2008;
h) UniCel DxC 800 PRO Part Number: A10407, Recall # Z-1101-2008
CODE
All Serial numbers. All software versions
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc, Brea, CA, decided that Customer Notification is not needed. Replacements began April 5, 2007. Firm initiated recall is ongoing.
REASON
Intermittent Failure of Stirrer Motor-Beckman Coulter has determined that incorrect Glucose results on LX20 or DxC instruments have been related to an intermittent failure of the stirrer motor. -Stirrer motors can stall without any flags or motion errors. -If a stall occurs during a GLUm test near the time of sample inject, results may be affected. -Affected GLUm results may be high or low.
VOLUME OF PRODUCT IN COMMERCE
2,599 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
a) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination
    of alanine aminotransferase in serum, 150 ml, Catalog no. A7526-150, in vitro
    diagnostic, Recall # Z-1110-2008;
b) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination
    of alanine aminotransferase in serum, 450 ml, Catalog no. A7526-450, in vitro
    diagnostic, Recall # Z-1111-2008;
c) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination
    of alanine aminotransferase in serum, 625 ml, Catalog no. A7526-625, in vitro
    diagnostic, Recall # Z-1112-2008;
d) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination
    of alanine aminotransferase in serum, 504 ml, Catalog no. HA926-504, in vitro
    diagnostic, Recall # Z-1113-2008;
e) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination
    of alanine aminotransferase in serum, 610 ml, Catalog no. HA926-610, in vitro
    diagnostic, Recall # Z-1114-2008;
f) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination
    of alanine aminotransferase in serum, 120 ml, Catalog no. 7-A7526-R1-120, in vitro
    diagnostic, Recall # Z-1115-2008;
g) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination
    of alanine aminotransferase in serum, 120 ml, Catalog no. 8-A7526-R1-120, in vitro
    diagnostic, Recall # Z-1116-2008;
h) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination
  of alanine aminotransferase in serum, 305 ml, Catalog no. HA 726-305, in vitro
    diagnostic, Recall # Z-1117-2008
CODE
a) Lots 628302-005, 628302-059, 628302-085, 628302-086, 628302-087, 704601-087,
    704601-130, 704601-131, 704601-134 and 704601-191;
b) Lots 628302-023, 628302-024, 628302-025, 628302-067, 628302-068, 704601-068,
    704601-107, 704601-108, 704601-109, 704601-134 and 704601-166;
c) Lots 704601-068 and 704601-123;
d) Lot 704601-165;
e) Lots 628302-004 and 704601-113;
f) Lots 628302-025, 628302-346 and 704601-108;
g) Lots 704601-088, 704601-155 and 704601-165;
h) Lot 628302-045
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Canton, MI, by letters dated December 14, 2007. Firm initiated recall is ongoing.
REASON
Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
VOLUME OF PRODUCT IN COMMERCE
955
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Keeler All Pupil II Indirect Ophthalmoscope, Recall # Z-1132-2008
CODE
Serial numbers: 86249, 85806, 85598, 85601, 86390, 67321, 85600, 85697, 86372, 86394, 85599, 85602, 66378, 85814, 86392, 85605, 66886, 66708, 86255, 85565, 85556, 85558, 85562, 86370, and 66882
RECALLING FIRM/MANUFACTURER
Recalling Firm: Keeler Instruments, Inc., Broomall, PA, by email dated January 8, 2008.
Manufacturer: Keeler Limited, Windsor, UK. Firm initiated recall is ongoing.
REASON
Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
NJ

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

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PRODUCT
Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Recall # Z-1166-2008
CODE
Lot Number: 0505017
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc, Irving, TX, by letter dated September 26, 2007. Firm initiated recall is ongoing.
REASON
Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all vials within a kit are affected. The investigation determined that the interferent affects Potassium (K+) only. Use of the affected calibrator vials will generate an acceptable, but low calibration slope. When Quality Control (QC) is run to verify the calibration, K+ QC results may be below acceptable QC ranges. This interferent does not affect Sodium (Na+) and Chloride (CL-).
VOLUME OF PRODUCT IN COMMERCE
1,377 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
MT-APSD-2.4 Type-@ Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable non-sterile (43.2cm) standard perforated thermoplastic head, neck and shoulder mask (2.4mm), 1 device per package, Recall # 1608-2008
CODE
Lot Number: 34415
RECALLING FIRM/MANUFACTURER
Recalling Firm: Civco Medical Instruments Inc, Kalona, IA, by letter on February 25, 2008.
Manufacturer: Med Tec Inc dba CIVCO Medical Solutions, Orange City, IA. Firm initiated recall is ongoing.
REASON
Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct.
VOLUME OF PRODUCT IN COMMERCE
160 masks
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
a) Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle
radiation therapy system; Part Number: MT-NW-887-805, Recall # Z-1613-2008;
b) Fiducial Markers (0.9 x 3 mm) Soft tissue gold markers, Medical charged-particle
radiation therapy system; Part Number: MT-NW-887-809, Recall # Z-1614-2008
CODE
a) Lot Number: 080117-01;
b) Lot Number: 080117-02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Med Tec Inc dba CIVCO Medical Solutions, Orange City, IA, by telephone beginning February 28, 2008 and letter on February 29, 2008.
Manufacturer: C P Medical, Portland, OR. Firm initiated recall is ongoing.
REASON
Mislabeled: Fiducial markers were incorrectly labeled. They are marked (0.9x3mm cylindrical) Soft tissue gold markers, but contain (2mm spheres) Bone gold markers.
VOLUME OF PRODUCT IN COMMERCE
36/3-marker pouches spherical markers and 33/3-marker pouches cylindrical markers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Recall # Z-1616-2008
CODE
Lot Numbers: W029275 and W029476.
RECALLING FIRM/MANUFACTURER
Cardiac Science Corp, Bothell, WA, by letter on January 23, 2008. Firm initiated recall is ongoing.
REASON
Adaptor Cable Incorrectly Manufactured: The red and white connector ends of the adapter are switched. Therefore, the cable will not connect to the electrodes as indicated in the instructions.
VOLUME OF PRODUCT IN COMMERCE
62 adaptors
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS III

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PRODUCT
1) Deer Corn (Straight Seed) packed in 25, 40 and 50 LB polywoven bags identified
    with the following brand names: Academy; Morning Song; Moultrie; Remington/
    Wild Game Innovations; Shelled Corn (No brand name listed) and Southern Grain,
    Recall # V-114-2008;
2) ACO brand Promo Wild Bird Blend packed in 20 LB polywoven bags,
    Recall # V-115-2008;
3) Andersons Bird Mix packed in 20 LB and 50 LB polywoven bags,
    Recall # V-116-2008;
4) Sunflower Chips, medium/fine identified as follows: Blended Chips (No brand name
    Listed) 50 LB polywoven bags; Fine Chips (no brand name listed) packed in 50 LB
    polywoven bags; and Morning Song Hearts & Chips 5.5 LB/9 size packed in plastic
    bags, Recall # V-117-2008;
5) Century Resources Wild Bird Food Bell 16 oz/32 oz. packed in plastic shrink wrap,
    Recall # V-118-2008;
6) Morning Song Deer and Turkey Mini Block packed in plastic bags,
    Recall # V-119-2008;
7) Black Oil Sunflower distributed under the following brand names and package sizes:
    Harris Teeter Black (Sunflower) Oil packed in 10 LB/5 and 5 LB/6 plastic bags;
    Meijer Black Oil Sunflower Seed packed in 10 LB/5 and 20 LB plastic and/or
    polywoven bags; Morning Song Black (sunflower) Oil, straight seed, packaged
    2 LB/20; 5 LB/6; 5 LB/6 ACO; 10 LB/5 ACO; 20 LB; 20 LB/42; 25 LB; 25 LB TRL;
     50 LB; and 50 LB/28, in plastic or polywoven bags; Nutriplan Black (sunflower) Oil
     (Straight Seed) 10 LB/5 packed in plastic bags; and Publix Black Oil 2 LB/20 packed
    in plastic bags, Recall # V-120-2008;
8) Harris Teeter Red Bird Feed packed in 7 LB/5 plastic bags, Recall # V-121-2008;
9) Harris Teeter Wild Bird Food 5 LB/5, 10 LB/5, and 20 LB plastic bags and/or
     polywoven bags, Recall # V-122-2008;
10) Country Pride Suet identified as: Meijer Natural Suet 11 oz/12 ; Morning Song
      High Energy Suet, sizes: 24 CT; 11 oz/12: 11 oz/24; and 22 oz/12, packed in plastic
      trays with labels; Morning Song Year-Round Sue, sizes: 10 PK Mini Palle; 10
      PK/4; 11.75 oz/12; 11.75 oz/24 packed in cardboard boxes and/or in plastic trays
      with label; .Royal Wing All Season Suet 12 CT packed in plastic trays with labels;
      Royal Wing High Energy Suet, 12 CT packed in plastic trays with labels; and
      Squirrel-Free Suet 11.75 oz/12 packed in plastic trays with labels,
      Recall # V-123-2008;
11) Meijer Natural Wild Bird Food packed 10 LB/5; 20 LB; and 40 LB in plastic and
    polywoven bags, Recall # V-124-2008;
12) Striped Sunflower products as follows: Morning Song Striped Sunflower food
      (Straight Seed), sizes: 5 LB/5; 10 LB/4 ACO: 10 LB/4; 20 LB; 40 LB; and 40 LB
      ACO, packed in plastic or polywoven bags; and Meijer Striped Sunflower Seed
      packed in 10 LB/4 plastic bags, Recall # V-125-2008;
13) Morning Song Apple Crisp (Suet) Dough, 12CT packed in plastic trays w/labels,
      Recall # V-126-2008;
14) Morning Song Backyard Songbird packed in 40 LB boxes packed in boxes with
      individual plastic bags, Recall # V-127-2008;
15) Morning Song Black (Sunflower) Oil Bell packed 10 oz/12 (Pressed Seed) packed
      in plastic shrink wrap, Recall # V-128-2008;
16) Morning Song Birdwatchers' Blend packed 4.5 LB/4; 7 LB/6; 8 LB/5; 9 LB/5;
      12 LB/4; and18 LB/3 in plastic bags, Recall # V-129-2008;
17) Birdwatchers Pressed Seed - products as follows: Morning Song Birdwatchers'
      Bar packed 13 oz/6; in plastic bags; Morning Song Birdwatchers' Bell packed
      10 oz/12 in plastic shrink wrap; Morning Song Birdwatcher Mini-Snack (Pressed
      Seed) 8 oz/12 packed in plastic bags; and Morning Song Birdwatchers' Snack,
      2 LB/4 packed in plastic bags, Recall # V-130-2008;
18) Morning Song Birdwatchers' Ready Feeder (Blend) packed in plastic tubes,
      Recall # V-131-2008;
19) Morning Song Birdwatchers' Suet (Suet/Dough) packed 10.75 oz/12; and
      10.75 oz/24 in plastic trays with labels; and Scotts Multi-Bird Suet 10.75 oz/12
    packed in plastic trays with labels, Recall # V-132-2008;
20) Morning Song Berry Punch Suet (Suet/Dough) 11.7 5 oz/12; and 11.75 oz/24
      packed in plastic trays with labels, Recall # V-133-2008;
21) Morning Song Bug Fest (Blend) 5 LB/4 CDN; 5 LB/4 SPAN; 9 LB/5; and 9 LB/6
      sizes packed in plastic bags, Recall # V-134-2008;
22) Morning Song Chickadee & Nuthatcher (Blended) food in 3 LB/12 size plastic bags,
      Recall # V-135-2008;
23) Morning Song Cherry Delight (Blend) in 3.5 LB/4 and 8.5 LB plastic bags,
      Recall # V-136-2008;
24) Morning Song Cherry Pie Dough, 12 CT (Suet/Dough) packed in plastic trays with
      labels, Recall # V-137-2008;
25) Morning Song Clean & Free (Blend) 5 LB/10: 10 LB/5; and 18 LB packed in
      plastic bags, Recall # V-138-2008;
26) Morning Song Country Pride -ACO (Blend) in sizes: 4 LB/14; 4 LB/440; 5 LB/10;
      10 LB/5; 10 LB/144; 20 LB; 20 LB VAR; 23 LB; and 50 LB packed in plastic
      and/or polywoven bags, Recall # V-139-2008;
27) Morning Song Cracked Corn (Straight Seed) in 4 LB/12; 5 LB/8; 5 LB8 ACO;
      25 LB; and 50 LB sizes packed in plastic and/or polywoven bags,
    Recall # V-140-2008;
28) Morning Song Cardinal Food (Blend) in 3.5 LB/10; 5 LB/8; 7 LB/5; 20 LB; and
      40 LB sizes and packed in plastic or polywoven bags, Recall # V-141-2008;
29) Morning Song Cardinal Snack (Pressed Seed) 1.75 LB/4 packed in plastic bags,
      Recall # V-142-2008;
30) Morning Song Deluxe Wild Bird Food (Blend) 10 LB/5; 20 LB; and 40 LB sizes
      packed in plastic or polywoven bags, Recall # V-143-2008;
31) Morning Song Dough-Nut (Suet/Dough) 12 CT packed in plastic trays with labels,
      Recall # V-144-2008;
32) Morning Song Dove food (Blend) 7 LB/6 packed in plastic bags,
      Recall # V-145-2008;
33) Morning Song Dove Block (Pressed Seed) 4.5 LB/2 packed in plastic bags,
      Recall # V-146-2008;
34) Morning Song Ear Corn (Straight Seed) 6.5 LB/156 packed in plastic bags,
      Recall # V-147-2008;
35) Morning Song Fall & Winter Blend in 18 LB; and 18 LB/3 sizes packed in plastic
      bags, Recall # V-148-2008;
36) Morning Song Finch Sock (Sock) Shipper packed in plastic bags; and Scotts
      Finch & Small Songbird Sock Feeder 13 oz/10, packed in plastic tubes,
      Recall # V-149-2008;
37) Morning Song Finch W/Canola Seed (Blend) 5 LB/8 size packed in plastic bags,
      Recall # V-150-2008;
38) Morning Song Finch & Chips (Blend), sizes: 5 LB/4 CDN; 5 LB/4 SPAN; 9 LB/6;
      and 9 LB/5 packed in plastic bags, Recall # V-151-2008;
39) Morning Song Fruit, Berry & Nut (Blend) sizes: 7 LB/5; 7 LB/36; 7 LB/6; and
      15 LB/3, packed in plastic bags, Recall # V-152-2008;
40) Morning Song Gourmet Wild Bird Food, 10 LB/5; and 20 LB/3 packed in plastic
      and/or polywoven bags, Recall # V-153-2008;
41) Morning Song Jazz Berry, sizes: 4.5 LB/4 CDN; 4.5 LB/4 SPAN, 9 and Smith &
      Hawken Jazz Berry Jug, Recall # V-154-2008;
42) Morning Song Nutty Safari (Blend) sizes: 4.25 LB/4 CDN; 4.25 LB/4 SPAN;
      9 LB/4; and Smith & Hawken Nutty Safari Jug (Blend) 6 LB/6, packed in plastic
      jugs, Recall # V-155-2008;
43) Morning Song Nutty Safari Suet (Suet/Dough), sizes: 11 oz/12; 11 oz/24; and
      Morning Song Nutty Safari Jumbo Suet, size: 24 oz/5. These products are packed
      in plastic trays with labels, Recall # V-156-2008;
44) Morning Song Orange Slice Dough 12 CT (Suet/Dough) packed in plastic trays with
      labels, Recall # V-157-2008;
45) Morning Song Peanuts (Straight Seed) 3 LB/6 packed in plastic bags,
      Recall # V-158-2008;
46) Morning Song Pumpkin Delight10 LB/5 (Blend) and 4 LB/8 sizes, packed in plastic
    bags, Recall # V-159-2008;
47) Morning Song Pumpkin Party, sizes: 4.5 LB/8 and 4.5 LB/4 (Blend) packed in plastic
      bags, Recall # V-160-2008;
48) Morning Song Premium Wild Bird Food (Blend) sizes: 5 LB/10; 10 LB/5;
      10 LB/144; 20 LB; 20 LB/1TRL; 20 LB/48; 40 LB. These items are packed in plastic
      and/or polywoven bags, Recall # V-161-2008
CODE
All codes manufactured and shipped between 11/15/2005 and 3/12/2008 was subject to recall.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Scotts Miracle Gro, Canal Winchester, OH, by telephone on March 25, 2008, and by letters on March 26 and 27, 2008.
Manufacturer: The Scotts Company LLC, Doland, SD. Firm initiated recall is ongoing.
REASON
Animal food intended for feeding non-domestic birds and other wildlife species were found to have been treated with pesticides which were not labeled with instructions for approved use only on wild bird or wild animal products or on all of the individual components that might be present in such stored grain mixtures.
VOLUME OF PRODUCT IN COMMERCE
61,019,671 units (includes totals for V-162/V-206-2008)
DISTRIBUTION
Nationwide
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PRODUCT
1) Morning Song Raisin Crunch Suet (Suet/Dough), 11.75 oz/12 and 11.75 oz/24 sizes
packed in plastic trays with labels; and Scotts Multi-Bird Suet with Fruit and Nuts (Suet/Dough) 11.75 oz/12 packed in plastic trays with labels, Recall # V-162-2008;
2) Morning Song Safflower (Straight Seed), sizes: 7 LB/33 and 7 LB/6 packed in plastic
      bags and Safflower (Straight Seed) sizes: 20 LB and 50 LB packed in polywoven
      bags, Recall # V-163-2008;
3) Morning Song Safflower Snack, (Pressed Seed) sizes: 1.7 LB, Recall # V-164-2008;
4) Morning Song Sunflower Suet (Suet/Dough) 9 oz/12 packed in plastic trays with
      labels, Recall # V-165-2008;
5) Morning Song Songbird food (Blend) , sizes: 7 LB/5 CDN; 7 LB/5; 14 LB/3 CDN;
      and 14LB/3, packed in plastic bags, Recall # V-166-2008;
6) Morning Song Songbird Garden Box, 35 LB box packed in a box with individual
      plastic bags, Recall # V-167-2008;
7) Morning Song Songbird Sock 8 oz/10, packed in plastic tubes, Recall # V-168-2008;
8) Woodpecker Pressed Seed - Products are as follows: Morning Song Snack and
     Basket Combo/2 (Pressed Seed) packed in plastic shrink wrap; Morning Song Snack-
     MMM's in 13 0z/4 size packed in plastic bags; Morning Song Woodpecker Bar &
     Basket/6 and Woodpecker Bar/6 Morning Song Woodpecker Snack 2 LB/4; and
     Woodpecker Mini Snack 7.5 oz/12 packed in plastic bags; and Scotts Woodpecker
     Snack (Pressed Seed) size 2 LB/4, placed in plastic bags, Recall # V-169-2008;
9) Morning Song Squirrel & Critter food (Blend), sizes: 5 LB/10; 10 LB/5; and 20 LB/3.
     These products were packed in plastic or polywoven bags, Recall # V-170-2008;
10) Morning Song Squirrel & Critter Snack (Pressed Seed) 2.2 LB/4 size packed in
      plastic bags, Recall # V-171-2008;
11) Morning Song Super Finch Bar (Pressed Seed) 14 oz/6 size packed in plastic bags,
      Recall # V-172-2008;
12) Morning Song Super Finch Food (Blend), sizes: 5 LB/8; and 10 LB/4 packed in
      plastic bags and Smith & Hawken Super Finch Jug, Recall # V-173-2008;
13) Morning Song Super Finch Snack, 4 LB/2 (Pressed Seed) packed in plastic bags,
      Recall # V-174-2008;
14) Morning Song Supreme Basket (Blend) 20 LB, packed in plastic buckets,
      Recall # V-175-2008;
15) Morning Song Trail Mix (Blend), sizes: 5 LB/8; 5 LB/50; 9 LB/4, packed in plastic
      bags, Recall # V-176-2008;
16) Morning Song Variety Suet (Suet/Dough) 3 PK/4 CDN; and Variety Suet W/Basket,
      15 pack. These items are distributed in cardboard boxes and/or plastic trays with
      labels, Recall # V-177-2008;
17) Morning Song Woodpecker food (Blend) 4 LB/10 packed in plastic bags,
      Recall # V-178-2008;
18) Morning Song Woodpecker Suet (Suet/Dough) sizes: 24 Ct; 3 PK/4; 9.5 oz/12; 9.5
     oz/24 packed in plastic trays with labels; and Scotts Woodpecker Suet (Suet/Dough)
      9.5 oz/12 size packed in plastic trays with labels, Recall # V-179-2008;
19) Morning Song White Millet (Straight Seed) 10 LB/5 packed in plastic bags,
      Recall # V-180-2008;
20) Morning Song Wild Bird Bell, sizes: 16 oz/12 and 6 PK/4 (Pressed Seed) packed in
      plastic shrink wrap; Morning Song Wild Bird Snack 2 LB/4: and Morning Song
      Wild Bird Mini-Snack 9 oz/12 packed in plastic bags or plastic shrink wrap,
      Recall # V-181-2008;
21) Morning Song Wild Finch Food (Blend) sizes: 3 LB/14; 8 LB/6; and 10 LB/5,
      packed in plastic bags, Recall # V-182-2008;
22) Morning Song Year-Round Wild Bird Food (Blend), sizes: 10 LB/5; 25 LB; 30 LB;
      50 LB; and 55 LB, Recall # V-183-2008;
23) Nutriplan Wild Bird Food (Blend) sizes: 5 LB/10; 10 LB/5; and 20 LB packed in
      plastic or polywoven bags, Recall # V-184-2008;
24) Peanut Pickouts (Straight Seed) 50 LB packed in polywoven bags,
      Recall # V-185-2008;
25) Publix Red Bird food (Blend) 7 LB/5 packed in plastic bags, Recall # V-186-2008;
26) Publix Wild Bird Food (Blend) sizes: 5 LB/10; 10 LB/5 and 20 LB/3, packed in
      plastic or polywoven bags, Recall # V-187-2008;
27) Purina Birdlovers' Blend sizes: 25 LB and 50 LB polywoven bags,
      Recall # V-188-2008;
28) Purina Regional Recipe (Blend) 25 LB and 50 LB sizes packed in polywoven bags,
      Recall # V-189-2008;
29) Royal Wing Birdlovers Suet 12 CT (Suet/Dough) packed in plastic trays with labels,
      Recall # V-190-2008;
30) Royal Wing Berry Suet (Suet/Dough) 12 CT, packed in plastic trays with labels,
      Recall # V-191-2008;
31) Royal Wing Peanut Suet (Suet/Dough) 12 CT packed in plastic trays with labels,
      Recall # V-192-2008;
32) Royal Wing Raisin Suet (Suet/Dough) packed in plastic trays with labels,
      Recall # V-193-2008;
33) Royal Wing Sunflower Suet (Suet/Dough) packed in plastic trays with labels,
      Recall # V-194-2008;
34) Royal Wing Woodpecker Suet (Suet/Dough) 12 CT packed in plastic trays with
      labels, Recall # V-195-2008;
35) Scotts Gourmet Finch Blend (Blend) 5 LB/6 packed in plastic bags, Recall #
      V-196-2008;
36) Scotts Seed Fruit & Berry (Blend) 5 LB/6 packed in plastic bags,
      Recall # V-197-2008;
37) Scotts No-Mess Patio Blend 5.5 LB/6 and No-Mess Patio Blend WBF 24 LB/1,
      (Blend) packed in plastic bags and 11 LB/4, Recall # V-198-2008;
38) Scotts Songbird Selection No-Mess Patio food (Blend) 11 LB/4, packed in plastic
      bags, Recall # V-199-2008;
39) Scotts Songbird Selection Finch & Small Songbirds (Blend) sizes: 5 LB/6; 6 LB/5;
      10 LB/4; 12 LB/4, packed in plastic bags, Recall # V-200-2008;
40) Scotts Songbird Selections Multi-Bird (Blend) sizes: 5 LB/44; 5 LB/6; 6 LB/6; 10
      LB/4; 12 LB/4; and 18 LB/3, packed in plastic bags, Recall # V-201-2008;
41) Scotts Songbird Selections Multi-Bird Fruit & Nut (Blend) sizes: 5 LB/6; 6 LB/6;
     10 LB/4; 12 LB/4, packed in plastic bags, Recall # V-202-2008;
42) Scotts Songbird Selections No-Mess Patio (Blend) sizes: 5.5 LB/6; 6.5 LB/6;
     and 13 LB/4, packed in plastic bags (*distribution amount includes 07 and 08
      product formulations which vary slightly in some non-key ingredients),
      Recall # V-203-2008;
43) Scotts Ultimate Songbird (Blend) sizes: 5 LB/6 and 10 LB/4, packed in plastic bags,
      Recall # V-204-2008;
44) Shoppers Value Wild Bird Food, 20 LB (Blend) packed in polywoven bags,
      Recall # V-205-2008;
45) Squirrel-Free Wild Bird Food (Blend) 8LB/4, packed in plastic bags,
      Recall # V-206-2008
CODE
All codes manufactured and shipped between 11/15/2005 and 3/12/2008 was subject to recall.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Scotts Miracle Gro, Canal Winchester, OH, by telephone on March 25, 2008, and by letters on March 26 and 27, 2008.
Manufacturer: The Scotts Company LLC, Doland, SD. Firm initiated recall is ongoing.
REASON
Animal food intended for feeding non-domestic birds and other wildlife species were found to have been treated with pesticides which were not labeled with instructions for approved use only on wild bird or wild animal products or on all of the individual components that might be present in such stored grain mixtures.
VOLUME OF PRODUCT IN COMMERCE
61,019,671 units (includes totals for V-114/V-161-2008)
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR MAY 28, 2008

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