• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for January 28, 2004

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.


January 28, 2004
04-04

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Response 4412, Texturized Vegetable Protein, packaged in
25-lb. bags. Recall # F-089-4.
CODE
Lot #03-193-1-02.
RECALLING FIRM/MANUFACTURER
Solae Llc, Saint Louis, MO, by telephone on September 10, 2003 and by letter dated September 12, 2003. Firm initiated recall is complete.
REASON
The product contains plastic particles.
VOLUME OF PRODUCT IN COMMERCE
1,600/25-lb. bags.
REASON
UT and IA.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Entex LA Capsules (phenylephrine extended
release/guaifenesin), phenylephrine HCI extended release
30mg/ guaifenesin immediate release 400mg, NEW FORMULATION,
100 count bottles, Rx only. Recall # D-104-4.
CODE
Lot numbers: 3785, 3786, 3787, 3788, 3789, and 3814.
RECALLING FIRM/MANUFACTURER
Andrx Pharmaceuticals, Inc., Weston, FL, by fax on December 16, 2003 and by letter dated December 19, 2003. Firm initiated recall is ongoing.
REASON
Mislabeling: Package insert states the color of the capsules as blue and yellow instead of purple and orange.
VOLUME OF PRODUCT IN COMMERCE
46,000 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS I

_______________________________
PRODUCT
Human Tissues. Recall # B-0382-4.
CODE
02932 #201 (TNA60) Left hemi-patellar tendon,
02932 #203 (TNR60) Right patellar tendon,
02932 #204 (TAL60) Left achilles tendon,
02932 #205 (TAR60) Right achilles tendon,
02932 #206 (TI060) Anterior tibialis tendon,
02932 #207 (TI060) Anterior tibialis tendon.
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, DBA Northwest Tissue Center, Seattle, WA, by telephone between August 5 and ll, 2003, and by letters dated November 7, 2003. Firm initiated recall is complete.
REASON
Human tissue, procured from a donor whose associated tissue was initially positive for Bacteroides species, was implanted. The recipient developed an infection from the same organism.
VOLUME OF PRODUCT IN COMMERCE
6 tissues.
REASON
WA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0563-4.
CODE
Unit 13GV46511.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on September 19, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
MI.

_______________________________
PRODUCT
Source Plasma. Recall # B-0565-4.
CODE
Unit SBG029367.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., South Bend, IN, by facsimile on or about October 1, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not complete a vCJD increased risk question, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
Spain.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0576-4.
CODE
Units 12LT52149 (Parts 1 & 2).
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by letter dated March 21, 2003. Firm initiated recall is complete.
REASON
Red Cells, lacking quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
REASON
NC.

_______________________________
PRODUCT
Red Blood Cells, Frozen. Recall # B-0577-4.
CODE
Unit 12GH12550.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by telephone on April 1, 2003. Firm initiated recall is complete.
REASON
Red Cells, labeled with a weight that was below the firm's minimum specification, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-0578-4.
CODE
Units: G-50415-018, G-50068-018, G-48810-018, G-47721-018, G-46289-018, G-46031-018, G-45061-018, G-44782-018,
G-43015-018, G-42574-018, G-41173-018, G-40573-018,
G-39338-018, G-38960-018, G-35073-018, G-34108-018,
G-33780-018, G-32854-018, G-31635-018, G-31287-018,
G-30525-018, G-30192-018, G-29439-018, G-29150-018,
G-28194-018, G-27844-018, G-26894-018, G-26634-018,
G-25659-018, G-25341-018, G-24224-018, G-23770-018,
G-12839-018, G-13125-018, G-14386-018, G-14736-018,
G-17239-018, G-32515-018.
RECALLING FIRM/MANUFACTURER
Recall Firm: Alpha Therapeutic Corporation, Bakersfield, CA, by letter dated November 7, 2001.
Manufacturer: Alpha Therapeutic Corporation, Fresno, CA. Firm initiated recall is complete.
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
38 units.
REASON
CA, Spain, and New Zealand.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0600-4.
CODE
Units 041LP31068, 041LP31055.
FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone on March 27, 2003, and by letter dated March 28, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
REASON
AL, and Switzerland.

_______________________________
PRODUCT
Source Plasma. Recall # B-0611-4.
CODE
Unit numbers: WN0002859, WN0002877, WG0017369, WG0017512,
WG0017728, WG0017870, WG0018254, WG0018375, WG0018600,
WG0018713, WG0018988, WG0019187, WG0019325, WG0019454,
WG0019587, WG0019750, WG0019872, WG0019992, WG0020139,
WG0020272, WG0020486, WG0020680, WG0020764, WG0020972,
WG0021042, WG0021239, WG0021331, WG0021516, WG0021586,
WG0021781, WG0021858, WG0022031, WG0022119, WG0022308,
WG0022401, WG0022607, WG0022693, WG0022853, WG0022949,
WG0023134, WG0023252, WG0023440, WG0023552, WG0023755,
and WG0023858.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Wilmington, DE, by facsimile on July 23, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for syphilis, but were collected from an ineligible donor based on previously reactive testing for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
45 units.
REASON
Spain.

_____________________________________
PRODUCT
Red Blood Cells. Recall # B-0612-4.
CODE
Unit number 1999412.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by facsimile on November 12, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
KY.

_______________________________
PRODUCT
Source Plasma. Recall # B-0613-4.
CODE
Unit number 53948342.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Dallas, TX, by facsimile on April 29, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from a donor that was previously deferred due to risk factor for increased incidence of infection with human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
CA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0614-4.
CODE
Unit number 17200-5228.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by telephone and letter on March 12, 2003. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
TX.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0564-4.
CODE
Units 15392-4572, 15392-7033, and 15393-0711 (Parts 1 & 2).
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock Center, Lubbock, TX, by telephone on July 22, 2002, and by letter dated July 30, 2002. Firm initiated recall is complete.
REASON
Blood products, that lacked assurance of proper storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
REASON
TX.

_______________________________
PRODUCT
Source Plasma. Recall $ B-0566-4.
CODE
Unit CP21278.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Colton, CA, by facsimile dated September 3, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
Austria.

_______________________________
PRODUCT
Source Plasma. Recall # B-0567-4.
CODE
Unit CT100496.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Colton, CA, by facsimile dated October 21, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
Austria.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0601-4.
CODE
Units 041LP31068, 041LP31055.
FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone on March 27, 2003, and by letter dated March 28, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
REASON
AL, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0615-4.
CODE
Unit number 26117-1784.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on May 21, 2003. Firm initiated recall is complete.
REASON
Blood product, that was not properly quarantined after the receipt of post donation information concerning medication with an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
AR.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Access AED and Access ALS Automated External Defibrillators Model No. 9100-0100. Recall # Z-0356-04.
CODE
Serial Numbers: 77067 77341 77374 77401 77427 77468 77068 77344 77375 77402 77428 77469 77215 77351 77376 77403 77429 77470 77217 77352 77377 77404 77430 77471 77287 77353 77378 77405 77432 77472 77288 77354 77379 77406 77433 77473 77295 77355 77380 77407 77434 77474 77296 77356 77381 77408 77435 77475 77297 77357 77382 77409 77436 77476 77302 77358 77383 77410 77437 77477 77303 77359 77384 77411 77438 77479 77304 77360 77385 77412 77439 77480 77305 77361 77386 77413 77440 77481 77306 77362 77387 77414 77441 77483 77307 77363 77388 77415 77442 77484 77308 77364 77389 77416 77443 77485 77309 77365 77390 77417 77444 77651 77319 77366 77391 77418 77445 77335 77320 77367 77392 77420 77446 77321 77368 77394 77421 77447 77334 77369 77396 77422 77448 77336 77370 77397 77423 77462 77337 77371 77398 77424 77463 77338 77372 77399 77425 77464 77339 77373 77400 77426 77465.
RECALLING FIRM/MANUFACTURER
Access CardioSystems, Concord, MA, by telephone and email on December 18, 2003 and December 19, 2003, and by letters dated December 19, 2003. Firm initiated recall is ongoing.
REASON
Difibrillator may fail to operate due to a faulty component on the circuit board.
VOLUME OF PRODUCT IN COMMERCE
143 units.
REASON
AL, CA, LA, FL, OR, NC, TN, and Grenada.

END OF ENFORCEMENT REPORT FOR January 28, 2004

###