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U.S. Department of Health and Human Services

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Enforcement Report for May 16, 2007

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 16, 2007
07-20

RECALLS AND FIELD CORRECTIONS:  FOODS AND COSMETICS - CLASS I

_________________________________
PRODUCT
a) J Hungerford Smith, Peanut Butter Flavored Dessert Topping,
    Net Wt 6 lbs 10oz (3.01kg), Ready-To-Serve, Recall # F-255-7;
b) Sonic, America’s Drive-In, Ready-To-Use, Peanut Butter Topping,
    Made with Peter Pan Peanut Butter, Artificially Flavored,
    Net WT 6 lb 10.5 oz (3.02 kg), Recall # F-256-7;
c) Carvel, Peanut Butter Topping, 420, Net Wt 6 lbs 10 oz (3.01 kg),
    Recall # F-257-7;
d) Peanut Butter Topping, Net Contents 6 lbs, 10 oz (3.01 kg), Recall # F-258-7
CODE
All product distributed from 12/01/2004 - 02/16/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Conagra Foods Inc, Omaha, NB, by letters via email and followed with telephone calls and person visits beginning on February 16, 2007and second letter on March 9, 2007.
Manufacturer:  J Hungerford Smith Inc AKA ConAgra Foods, Humboldt, TN.  Firm initiated recall is ongoing.
REASON
Product contains peanut butter which may be contaminated with Salmonella Tennessee.
VOLUME OF PRODUCT IN COMMERCE
99,593 cases
DISTRIBUTION
Nationwide, Canada, Singapore and Slovenia

RECALLS AND FIELD CORRECTIONS:  FOODS AND COSMETICS - CLASS II

___________________________________
PRODUCT
a) FERROUS GLUCONATE 324MG TABLET, 250 count bags (NDC #61392022625),
    30 count bingo card (NDC #61392022639) & 30 count box (NDC #61392022630),
    OTC, Recall # F-242-7;
b) FERROUS SULFATE 325MG TABLET GREEN, 250 count bags
    (NDC #61392012725), 30 count bingo card (NDC #61392012739),
    30 count boxes (NDC #61392012730), 60 count boxes (NDC #61392012760)
    & 90 count boxes (NDC #61392012790), OTC, F-243-7;
c) ONE TAB DAILY TABLET, 250 count bags (NDC #61392093825) &
    30 count boxes (NDC #61392093830), OTC, Recall # F-244-7;
d) ONE TAB DAILY W/ IRON TABLET, 250 count bags (NDC #61392001525)
    & 30 count boxes (NDC #61392001530), OTC, Recall # F-245-7;
e) OYSTER SHELL 500MG TABLET, 250 count bags (NDC #61392000625),
    30 count bingo card (NDC #61392000639), 30 count boxes (NDC #61392000630)
    & 60 count boxes (NDC #61392000660), OTC, Recall # F-246-7;
f) VITAMIN B1 (THIAMINE) 50MG TABLET, 30 count bingo card (NDC #61392050639),
    OTC, Recall # F-247-7;
g) VITAMIN B12 1000MCG TABLET, 30 count bingo card (NDC #61392057539), OTC,
    Recall # F-248-7;
h) VITAMIN B12 100MCG TABLET, 30 count bingo card (NDC #61392050239)
    & 30 count boxes (NDC #61392050230), OTC, Recall # 249-7;
i) VITAMIN B12 500MCG TABLET, 250 count bags (NDC #61392050325),
    30 count bingo card (NDC #61392050339) & 30 count boxes (NDC #61392050330),
    OTC, Recall # F-250-7;
j) VITAMIN C 250MG TABLET (ASCORBIC ACID), 250 count bags
    (NDC #61392015525), 30 count bingo card (NDC #61392015539),
    30 count boxes (NDC #61392015530), OTC, Recall # F-251-7;
k) CALCIUM CARBONATE W/D 600MG TABLET, Recall # F-252-7;
l) CALCIUM W/D 250MG/125IU TABLET, 250 count bags (NDC #61392004725),
    30 count bingo card (NDC #61392004739), & 30 count boxes (NDC #61392004730),
    OTC, Recall # F-253-7;
m) CALCIUM W/D 500MG/200IU TABLET, 250 count bags (NDC #61392065325),
    30 count bingo card (NDC #61392065339), 30 count boxes (NDC #61392065330),
    60 count boxes (NDC #61392065360), OTC, Recall # F-254-7
CODE
a) All Lot Codes: U39727B25, U39727C25, U41009A25, U41946B25, 226M0501,
    226A0646, 226E0617, U39727A30, U41009B30, U41946A30;
b) All Lot Codes: U37269B25, U37519A25, U37519C25, U38039B25, 127D0512,
    127F0513, 127G0503, 127H0503, 127j0504, U36642C30, U36781C30,
    U36781D30, U36781F30, U37519B30, U38346B30, U38346C30, U38346D30,
    U37519D30, U38039C30, U36642A60, U36781A60, U36781B60, U36642E60,
    U36781E60, U37269A60, U37146A60, U38346A60, U38039D60, U38346E60,
    U36642B90, U36642D90, U38039A90;
c) All Lot Codes: U36554B25, U36271D25, U36554C25, U37557B25, U38195B25,
    U38944A25, U40237A25, U40434A25, C40481B25, U41252A25, U41252B25,
    C41967B25, C42641B25, C43073B25, U36271A30, U36271B30, U36271C30, 
    U36554A30, U37009A30, U36779A30, U36554D30, U36554E30, U37557A30,
    U37809A30, U38042A30, U38042B30, U38195A30, U38943A30, U38603A30,
    U38603B30, U38944B30, C39966A30, U38943B30, U39177A30, C39966B30,
    C40481, U40237B30, U40434B30, C41967A30, C41967C30, C41967D30,
    U41991A30, C42641A30, C43073A30, C43310A30, C43310B30;
d) All Lot Codes: U36246A25, U37140B25, U37807B25, U38679A25, U39855B25,
    U39855C25, U41174A25, U36246B30, U36246C30, U37140A30, U37807A30,
    U37807C30, U38389A30, U38679B30, U37140C30, U37807D30, U38389B30,
    U39855A30, U39855D30, U40601B30, U41174B30, U43046A30;
e) All Lot Codes: U36507B25, U36922B25, U37139B25, U39260A25, U37139E25,
    U36922D25, U40314A25, U40314D25, U40953A25, U42672A25, 36457, 006E0508,
    006F0513, 006G0507, 006H0509, 006j0504, 006J0516, 006K0517, 39009, 006L0532,
    006M0517, 006A0624, 006A0627, 066B0615, 006D0602, 006E0603, 006F0633,
    006E0602, 43204, U36507A30, U36922A30, U36242B30, U36922C30, U37139C30,
    U38852A30, U39260B30, U39022A30, U38147A30, U37882C30, U38852B30,
    U40000A30, U39803B30, U40000B30, U40314B30, U40314E30, U40953C30,
    U43268B30, U36242A60, U37139A60, U37139D60, U37882A60, U37882B60,
    U39803A60, U40314C60, U40953B60, U41563A60, U41941A60, U41630A60,
    U42672B60, U43268A60;
f) All Lot Codes: 39157, 506M0540;
g) All Lot Codes: 37002, 37235, 37683, 37897, 575k0531, 575A0621, 41079,
    41584, 575E0622
h) All Lot Codes: 39156, 39940, 41078, U41634A30;
i) All Lot Codes: U41635A25, 38459, 39458, 503A0650, 41740, 42769, U41635B30;
j) All Lot Codes: U41007B25, C42424A25, 36191, 36588, 38994, 38995,
    155M0517, 155C0613, U41007A30, C42426B30, C42424A30;
k) All Lot Codes: C41644A30;
l) All Lot Codes: U39848B25, U40168A25, U40604A25, U41177B25, U41177C25,
   047k0508, 047L0533, 047M0520, 047A0612, 047B0645, 047EO632, 42845,
   U38439A30, U38439B30, U38439C30, U39848A30, U39848C30, U40168B30,
   U40604B30, U40604C30, U41177A30, U41177D30;
m) All Lot Codes: U40264A25, U40282A25, U40282D25, U40635A25, U40112D25,
    U40282E25, U40635B25, U41876A25, U42232A25, U42569A25, U42603A25,
    U43214D25, 653A0606, 653A0634, 653A0652, 653B0623, 653B0628, 653D0602,
    653D0628, 653F0607, 653F0640, 653E0620, 653F0608, U40112C30, U40264B30,
    U40264C30, U40264E30, U40264D30, U40282B30, U40282C30, U41876C30,
    U41876D30, U42232C30, U42569C30, U42568A30, U42568B30, U43214B30,
    U43214A30, U43214C30, U40112B60, U40112A60, U40635C60, U40810A60,
    U41876B60, U42232B60, U42568C60, U42603B60, U42569B60, U43214E60
RECALLING FIRM/MANUFACTURER
Heartland Repack Services LLC, Toledo, OH, by telephone between February 14 and February 20, 2007.  Firm initiated recall is ongoing.
REASON
Misbranding. There is the possibility of multiple product packaging mix-ups. An OTC drug, RX drug, or nutritional supplement, other than what is indicated on the product labeling, may be inside the packaging.
VOLUME OF PRODUCT IN COMMERCE
31,485,030 units= 2,140,500/250 count; 257,220/90 count; 4,043,400/60 count & 25,043910/30 count
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
New Alpine Xtreme Evergreen Forest Body Wash, packaged in 28 fl. oz. plastic bottles, 6 bottles per case, Recall # F-259-7
CODE
Lot # 286071
RECALLING FIRM/MANUFACTURER
Vi Jon Laboratories, Inc, Saint Louis, MO, by telephone on April 13, 2007 and by e-mail on April 24, 2007.  Firm initiated recall is ongoing.
REASON
The product is contaminated with Enterobacter gergoviae.
VOLUME OF PRODUCT IN COMMERCE
10,242/28 fl. oz. bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I

___________________________________
PRODUCT
Ultra-TechneKow® DTE Technetium Tc 99m Generator (UTK-DTE™), radiopharmaceutical, Rx only, catalogue numbers N883 through N895, Recall # D-481-2007
CODE
Lot 7030, exp. 3/9/07
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Mallinckrodt Inc, Hazelwood, MO, by letters on March 5, 2007 and March 7, 2007.
Manufacturer:  Mallinckrodt Inc, Maryland Heights, MO. Firm initiated recall is ongoing.
REASON
Sterility test failure
VOLUME OF PRODUCT IN COMMERCE
166 generators
DISTRIBUTION
Nationwide, Canada, Panama, Dominican Republic, Mexico and Colombia

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT
Ultra-TechneKow® DTE Technetium Tc 99m Generator (UTK-DTE™), radiopharmaceutical, Rx only, catalogue numbers N884 through N895, Recall # D-482-2007
CODE
Lots: 7032, exp. 3/12/07; 7801, exp. 3/12/07; 7033, exp. 3/14/07
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Mallinckrodt Inc, Hazelwood, MO, by letters on March 5, 2007 and March 7, 2007.
Manufacturer:  Mallinckrodt Inc, Maryland Heights, MO. Firm initiated recall is ongoing.
REASON
Lack of sterility assurance
VOLUME OF PRODUCT IN COMMERCE
365 generators
DISTRIBUTION
Nationwide, Canada, Panama, Dominican Republic, Mexico and Colombia
___________________________________
PRODUCT
1) CARBAMAZEPINE 200MG TABLET, 250 count bags (NDC #61392003825), 30 count bingo card (NDC #61392003839), 60 count bingo card (NDC #61392003865), 30 count box (NDC #61392003830), 60 count box (NDC #61392003860) & 90 count box (NDC #61392003890), Rx, Recall # D-654-2007;

2) CARBAMAZEPINE CHEW 100MG TABLET, 250 count bags (NDC #61392002925), 30 count bingo card (NDC #61392002939) & 30 count boxes (NDC #61392002930), Rx, Recall # D-655-2007;

3) CARBIDOPA LEVODOPA 10/100MG TABLET, 250 count bags (NDC #61392017725), 30 count boxes (NDC #61392017730) & 60 count boxes (NDC #61392017760), Rx, Recall # D-656-2007;

4) CARBIDOPA LEVODOPA 25/100MG TABLET, 250 count bags (NDC #61392018025), 30 count bingo card (NDC #61392018039), 31 count bingo card (NDC #61392018031), 60 count bingo card (NDC #61392018065), 90 count bingo card (NDC #61392018095), 30 count boxes (NDC #61392018030), 60 count boxes (NDC #61392018060) & 90 count boxes (NDC #61392018090), Rx, Recall # D-657-2007;

5) CARBIDOPA LEVODOPA 25/250MG TABLET, 250 count bags (NDC #61392018325), 30 count bingo card (NDC #61392018339), & 30 count boxes (NDC #61392018330), Rx, Recall # D-658-2007;

6) CARBIDOPA LEVODOPA ER 50/200MG TABLET, 250 count bags (NDC #61392064725) & 30 count boxes (NDC #61392064730), Rx, Recall # D-659-2007;

7) CARISOPRODOL 350MG TABLET (c), 30 count bingo card (NDC #61392094939), Rx, Recall # D-660-2007;

8) CHLORDIAZAPOXIDE 25MG CAPSULE (c), 30 count bingo card (NDC #61392053439), Rx, Recall # D-661-2007;

9) CHLORPROMAZINE 10MG TABLET, 30 count bingo card (NDC #61392088039), Rx, Recall # D-662-2007;

10) CHLORPROMAZINE 200MG TABLET, 30 count bingo card (NDC #61392088239), Rx, Recall # D-663-2007;

11) CHLORPROMAZINE 25MG TABLET, 30 count bingo card (NDC #61392004039), Rx, Recall # D-664-2007;

12) CHLORPROMAZINE 50MG TABLET, 30 count bingo card (NDC #61392088139), Rx, Recall # D-665-2007;

13) CIMETIDINE 400MG TABLET, 30 count bingo card (NDC #61392020039), Rx, Recall # D-666-2007;

14) CLINDAMYCIN 300MG CAPSULE, 30 count bingo card (NDC #61392077439), Rx, Recall # D-667-2007;

15) CLOMIPRAMINE 50MG CAPSULE, 30 count bingo card (NDC #61392088539), Rx, Recall # D-668-2007;

16) CLONAZEPAM 0.5MG TABLET (c), 15 count bingo card (NDC #61392082515), 30 count bingo card (NDC #61392082539), 31 count bingo card (NDC #61392082531) & 15 count bingo card (NDC #61392082505), Rx, Recall # D-669-2007;

17) CLONAZEPAM 1MG TABLET (c), 30 count bingo card (NDC #61392082639), 31 count bingo card (NDC #61392082631) & 15 count bingo card (NDC #61392082605), Rx, Recall # D-670-2007;

18) CLONAZEPAM 2MG TABLET (c), 30 count bingo card (NDC #61392082839) & 31 count bingo card (NDC #61392082831), RX, Recall # D-671-2007;

19) CLONIDINE HCL 0.1MG TABLET, 250 count bags (NDC #61392051325), 30 count bingo card (NDC #61392051339), 31 count bingo card (NDC #61392051331), 30 count boxes (NDC #61392051330) 60 count boxes (NDC #61392051360), 90 count boxes (NDC #61392051390); & 15 count bingo card (NDC #61392051305), Rx, Recall # D-672-2007;

20) CLONIDINE HCL 0.2MG TABLET, 250 count bags (NDC #61392051625), 30 count bingo card (NDC #61392051639), 31 count bingo card (NDC #61392051631), 30 count boxes (NDC #61392051630) & 60 count boxes (NDC #61392051660), Rx, Recall # D-673-2007;
 
21) CLONIDINE HCL 0.3MG TABLET, 250 count bags (NDC #61392051925), 30 count bingo card (NDC #61392051939) & 30 count boxes (NDC #61392051930), Rx, Recall # D-674-2007;

22) COLCHICINE 0.6MG TABLET, 250 count bags (NDC #61392017425), 30 count bingo card (NDC #61392017439), & 30 count boxes (NDC #61392017430), Rx, Recall # D-675-2007;

23) CYCLOBENZAPRINE 10MG TABLET, 250 count bags (NDC #61392009825) & 30 count boxes (NDC #61392009830), Rx, Recall # D-676-2007;

24) CYPROHEPTADINE 4MG TABLET, 250 count bags (NDC #61392020925) & 30 count boxes (NDC #61392020930), Rx, Recall # D-677-2007;

25) DIAZEPAM 10MG TABLET (c), 30 count bingo card (NDC #61392053539), Rx, Recall # D-678-2007;

26) DIAZEPAM 2MG TABLET (c), 30 count bingo card (NDC #61392072639), Rx, Recall # D-679-2007;

27) DIAZEPAM 5MG TABLET (c), 30 count bingo card (NDC #61392083139), 31 count bingo card (NDC #61392083131) & 15 count bingo card (NDC #61392083105), Rx, Recall # D-680-2007;

28) DICYCLOMINE 10MG CAPSULE, 250 count bags (NDC #61392018225), 30 count bingo card (NDC #61392018239) & 30 count boxes (NDC #61392018230), Rx, Recall # D-681-2007;

29) DICYCLOMINE 20MG TABLET, 250 count bags (NDC #61392004125), 30 count bingo card (NDC #61392004139) & 30 count boxes (NDC #61392004130), Rx, Recall # D-682-2007;

30) DIGITEK 0.125MG TABLET, 250 count bags (NDC #61392099825), 30 count bingo card (NDC #61392099839), 31 count bingo card (NDC #61392099831), 30 count boxes (NDC #61392099830) & 15 count bingo card (NDC #61392099805), Rx, Recall # D-683-2007;

31) DIGITEK 0.25MG TABLET, 250 count bags (NDC #61392083925), 30 count bingo card (NDC #61392083939), 31 count bingo card (NDC #61392083931), 30 count boxes (NDC #61392083930) & 15 count bingo card (NDC #61392083905), Rx, Recall # D-684-2007;

32) DILTIAZEM 120MG TABLET, 250 count bags (NDC #61392014525), 30 count bingo card (NDC #61392014539), & 30 count boxes (NDC #61392014530), Rx, Recall # D-685-2007;

33) DILTIAZEM 30MG TABLET, 250 count bags (NDC #61392005325), 30 count bingo card (NDC #61392005339), 30 count boxes (NDC #61392005330) & 60 count boxes (NDC #61392005360), Rx, Recall # D-686-2007;

34) DILTIAZEM 60MG TABLET, 250 count bags (NDC #61392072025) & 30 count boxes (NDC #61392072030), Rx, Recall # D-687-2007;

35) DILTIAZEM 90MG TABLET, 30 count bingo card (NDC #61392014639) & 30 count boxes (NDC #61392014630), Rx, Recall # D-688-2007;

36) DILTIAZEM ER 120MG CAPSULE, 250 count bags (NDC #61392096125), 30 count bingo card (NDC #61392096139) & 30 count boxes (NDC #61392096130), Rx, Recall # D-689-2007;

37) DILTIAZEM ER 180MG CAPSULE, 250 count bags (NDC #61392096225), 30 count bingo card (NDC #61392096239) & 30 count boxes (NDC #61392096230), Rx, Recall # D-690-2007;

38) DILTIAZEM ER 240MG CAPSULE, 250 count bags (NDC #61392096325), 30 count bingo card (NDC #61392096339) & 30 count boxes (NDC #61392096330), Rx, Recall # D-691-2007;

39) DILTIAZEM ER 300MG CAPSULE, 250 count bags (NDC #61392096425), 30 count bingo card (NDC #61392096439) & 30 count boxes (NDC #61392096430), Rx, Recall # D-692-2007;

40) DIPHENHYDRAMINE 25MG CAPSULE, 250 count bags (NDC #61392022025) & 30 count boxes (NDC #61392022030), Rx, Recall # D-693-2007;
 
41) DIPHENOXY W/ATROP 2.5/.025MG TABLET (c), 30 count bingo card (NDC #61392086539), Rx, Recall # D-694-2007;

42) DIPYRIDAMOLE 25MG TABLET, 30 count bingo card (NDC #61392054939), Rx, Recall # D-695-2007;

43) DIPYRIDAMOLE 50MG TABLET, 30 count bingo card (NDC #61392055239), Rx, Recall # D-696-2007;

44) DIPYRIDAMOLE 75MG TABLET, 30 count bingo card (NDC #61392014239), Rx, Recall # D-697-2007;

45)DOCUSATE CALCIUM 240MG CAPSULE, 250 count bags (NDC #61392021325) & 30 count boxes (NDC #61392021330), OTC, Recall # D-698-2007;

46) DOCUSATE SODIUM 100MG CAPSULE, 250 count bags (NDC #61392001925), 30 count boxes (NDC #61392001930) & 60 count boxes (NDC #61392001960), OTC, Recall # D-699-2007;

47) DOXAZOSIN 1MG TABLET, 30 count bingo card (NDC #61392065439) & 30 count boxes (NDC #61392065430), Rx, Recall # D-700-2007;

48) DOXAZOSIN 2MG TABLET, 250 count bags (NDC #61392065625), 30 count bingo card (NDC #61392065639) & 30 count boxes (NDC #61392065630), Rx, Recall # D-701-2007;

49) DOXAZOSIN 4MG TABLET, 30 count bingo card (NDC #61392065539), Rx, Recall # D-702-2007;

50) DOXAZOSIN 8MG TABLET, 30 count bingo card (NDC #61392065739) & 30 count box (NDC 61392065730), Rx, Recall # D-703-2007;

51) DOXEPIN 50MG CAPSULE, 30 count bingo card (NDC #61392012239), Rx, Recall # D-704-2007;

52) DOXEPIN HCL 10MG CAPSULE, 30 count bingo card (NDC #61392012039), Rx, Recall # D-705-2007;

53) DOXEPIN HCL 25MG CAPSULE, 30 count bingo card (NDC #61392012139), Rx, Recall # D-706-2007;

54) ENALAPRIL 10MG TABLET, 250 count bags (NDC #61392065125) & 30 count boxes (NDC #61392065130), Rx, Recall # D-707-2007;

55) ENALAPRIL 2.5MG TABLET, 250 count bags (NDC #61392064925), Rx, Recall # D-708-2007;

56) ENALAPRIL 20MG TABLET, 30 count bingo card (NDC #61392065239), Rx, Recall # D-709-2007;

57) ENALAPRIL 5MG TABLET, 250 count bags (NDC #61392065025) & 30 count boxes (NDC #61392065030), Rx, Recall # D-710-2007;

58) FAMOTIDINE 20MG TABLET, 250 count bags (NDC #61392066325), 30 count bingo card (NDC #61392066339), 30 count box (NDC #61392066330), & 60 count box (NDC #61392066360), Rx, Recall # D-711-2007;

59) FAMOTIDINE 40MG TABLET, 30 count bingo card (NDC #61392066439), Rx, Recall # D-712-2007;

60) FLUDROCORTISONE 0.1MG TABLET, 250 count bags (NDC #61392058325), 30 count bingo card (NDC #61392058339) & 30 count boxes (NDC #61392058330), Rx, Recall # D-713-2007;

61) FLUOXETINE 10MG TABLET, 250 count bags (NDC #61392056125) & 30 count boxes (NDC #61392056130), Rx, Recall # D-714-2007;

62) FLUOXETINE 20MG CAPSULE, 250 count bags (NDC #61392066925) & 30 count boxes (NDC #61392066930), Rx, Recall # D-715-2007;

63) FLUOXETINE 40MG CAPSULE, 30 count bingo card (NDC #61392074039), Rx, Recall # D-716-2007;

64) FLUPHENAZINE 10MG TABLET, 30 count bingo (NDC #61392015039), Rx, Recall # D-717-2007;

65) FLUPHENAZINE 1MG TABLET, 30 count bingo card (NDC #61392005739), Rx, Recall # D-718-2007;

66) FLUPHENAZINE 2.5MG TABLET, 30 count bingo card (NDC #61392005839), Rx, Recall # D-719-2007;

67) FLUPHENAZINE 5MG TABLET, 30 count bingo card (NDC #61392015139), Rx, Recall # D-720-2007;

68) FOLIC ACID 1MG TABLET, 250 count bag (NDC #61392024425), 30 count boxes (NDC #61392024430), & 60 count boxes (NDC #61392024460), Rx, Recall # D-721-2007;

69) FUROSEMIDE 20MG TABLET, 250 count bags (NDC #61392025625), 30 count bingo card (NDC #61392025639), 31 count bingo card (NDC #61392025631), 30 count boxes (NDC #61392025630), 60 count boxes (NDC #61392025660), 90 count boxes (NDC #61392025690) & 15 count bingo card (NDC #61392025605), Rx, Recall # D-722-2007;

70) FUROSEMIDE 40MG TABLET, 250 count bags (NDC #61392025325), 30 count bingo card (NDC #61392025339), 60 count bingo card (NDC #61392025365), 30 count boxes (NDC #61392025330), 60 count boxes (NDC #61392025360) & 15 count bingo card (NDC #61392025305), Rx, Recall # D-723-2007;

71) FUROSEMIDE 80MG TABLET, 250 count bags (NDC #61392025425), 30 count bingo card (NDC #61392025439), 30 count boxes (NDC #61392025430), 60 count boxes (NDC #61392025460) & 15 count bingo card (NDC #61392025405), Rx, Recall # D-724-2007;

72) GABAPENTIN 100MG CAPSULE, 250 count bags (NDC #61392076025) & 30 count boxes (NDC #61392076030), Rx, Recall # D-725-2007;

73) GABAPENTIN 100MG TABLET, 60 count boxes (NDC #61392075360), Rx, Recall # D-726-2007;

74) GABAPENTIN 300MG CAPSULE, 250 count bags (NDC #61392076125) & 30 count boxes (NDC #61392076130), Rx, Recall # D-727-2007;

75) GABAPENTIN 300MG TABLET, 30 count boxes (NDC #61392074830), Rx, Recall # D-728-2007;

76) GABAPENTIN 400MG CAPSULE, 250 count bags (NDC #61392076225) & 30 count boxes (NDC #61392076230), Rx, Recall # D-729-2007;

77) GEMFIBROZIL 600MG TABLET, 30 count bingo card (NDC #61392009339) & 31 count bingo card (NDC #61392009331), Rx, Recall # D-730-2007;

78) GLIPIZIDE 10MG TABLET, 250 count bags (NDC #61392006425), 30 count bingo card (NDC #61392006439), 30 count boxes (NDC #61392006430), & 60 count boxes (NDC #61392006460), Rx, Recall # D-731-2007;

79) GLIPIZIDE 5MG TABLET, 250 count bags (NDC #61392006325), 30 count bingo card (NDC #61392006339) & 30 count boxes (NDC #61392006330), Rx, Recall # D-732-2007;

80) GLYBURIDE 2.5MG TABLET, 250 count bags (NDC #61392070925), 30 count bingo card (NDC #61392070939) & 30 count boxes (NDC #61392070930), Rx, Recall # D-733-2007;

81) GLYBURIDE 5MG TABLET, 250 count bags (NDC #61392083425), 30 count bingo card (NDC #61392083439), 31 count bingo card (NDC #61392083431), 30 count boxes (NDC #61392083430) & 60 count boxes (NDC #61392083460), Rx, Recall # D-734-2007
CODE
1) All Lot Codes: U37155B25, U37881B25, U37881C25, U38723B25, U37881E25, U38200B25, U39689A25, U39689B25, U38723H25, U41283A25, U41283G25, C41416B25, U42048A25, U42064A25, U42668A25, 37030, 37169, 038G0505, 038h0512, 038J0522, 038L0507, 038A0646, 038A0657, 038B0628, 038B0637, 038B0642, 038D0620, 038E0603, 038G0510, 038A0644, 038E0615, U37155C30, U37352A30, U37352B30, U37529A30, U38723C30, U38723E30, U39742A30, U39742B30, U39689C30, U38723K30, U41283D30, C41416A30, U42048D30, U42064D30, U37155A60, U37529B60, U37881A60, U38200A60, U38723F60, U38723G60, U41283C60, U41283E60, U42048C60, U42064C60, U42668B60, U37881D90, U38723A90, U38723D90, U38723J90, U41283B90, U41283F90, U42048B90, U42064B90;

2) All Lot Codes: U37270B25, U38367B25, U38873B25, U39518B25, U40001A25, U42673A25, 029H0525, 029H0529, 38532, 029k0520, 029L0521, 029M0514, 029A0621, 029A0659, 029C0622, 029C0630, 029D0616, 029D0627, 029F0625, 029F0626, U37270A30, U38367A30, U38367C30, U38873A30, U39518A30, U39784A30, U39784B30, U39635B30, U40001B30, U39635A30, U42673B30, U42968A30;

3) All Lot Codes: U37598C25, U38915B25, U39605B25, U40169A25, U40830B25, U41589A25, U37598A30, U38198A30, U37598D30, U38198B30, U38915A30, U39605B30, U40169B30, U40169D30, U40830A30, U40830D30, U41589C30, U37598B60, U38915C60, U40169C60, U40830C60, U41589B60;

4) All Lot Codes: U36923C25, U37513B25, U38146A25, U38722C25, U38413B25, U39220A25, U39786B25, U41006A25, U42065B25, C42674B25, C42632C25, 180D0520, 180G0501, 180H0504, 180H0526, 180J0530, 180L0506, 180L0525, 180M0513, 180M0546, 180A0649, 180C0618, 180D0618, 180D0619, 180E0614, 180E0616, 180F0621, 180F0635, 180F0637, 42844, 180F0622, 180h0513, 180A0643, 180C0621, 180E0615, 180G0509, 180j0516, 180L0524, 180C0620, U36836A30, U36923B30, U37513C30, U37846A30, U38146A30, U38722A30, U38146B30, U38471B30, U39220B30, U38722D30, U39220D30, U39495A30, U39786C30, U40438A30, C41451A30, U42608A30, C42632A30, C42986A30, C43203A30, C43308A30, U36836B60, U36836C60, U37846B60, U38471A30, U38722B60, U39786B60, U38471C60, U40438B60, U41006B60, U41371B60, C41451B60, U42089A60, U42065A60, U42608B60, C42674C60, U43313B60, C43308B60, U36836D90, U36923A90, U36923D90, U37513A90, U37268A90, U38413A90, U39220C90, U41006C90, U41371A90, C42632B90, C42986B90, C43203B90, U43313A90;

5) All Lot Codes: U39801A25, U39376A25, U39376B25, U40390B25, U41571A25, U42440A25, 183F0525, 183G0510, 183H0508, 183J0505, 183k0524, 183L0522, 183M0517, 183M0540, 183A0603, 183B0619, 183B0629, 183C0603, 183C0624, 183D0602, 183D0619, 183E0610, 183F0635, 183G0601, U37906A30, U37906B30, U37906C30, U38946A30, U39376A30, U39801B30, U40390A30, U39801C30, U40390C30, U40766A30, U40766B30, U41571B30, U42440B30;

6) All Lot Codes: U39499B25, U39499A30, U41697R30, U41702R30;

7) All Lot Codes: 949H0508, 949k0523, 949B0625, 41804, 949E0602;

8) All Lot Codes: 37993;

9) All Lot Codes: 38397, 39902;

10) All Lot Codes: 36612, 37228, 882M0540;

11) All Lot Codes: 37214, 040J0525, 040M0511, 41262;

12) All Lot Codes: 881A0615, 881B0607;

13) All Lot Codes: 40667, 43340;

14) All Lot Codes: 39907, 41263, 43336;

15) All Lot Codes: 36673, 37210, 39399, 885M0529;

16) All Lot Codes: 825G0512, 825H0517, 825k0515, 825m0515, 825F0629, 825E0612, 825C0523, 825D0521, 37334, 825F0528, 37421, 825G0505, 825H0504, 825H0513, 825k0531, 825k0548, 825L0542, 825K0517, 825a0610, 825M0533, 825B0608, 825B0612, 825B0630, 825D0605, 825D0624, 825E0609, 825F0635, 825F0637, 825G0608, 38839, 39433, 825F0633, 42023, 825D0606;

17) All Lot Codes: 826D0591, 826F0520, 826G0507, 826H0513, 826J0508, 826L0532, 826A0608, 826M0521, 826B0601, 826B0621, 826D0625, 826D0624, 826E0609, 826F0635, 39899, 826B0605, 42024, 43805;

18) All Lot Codes: 37305, 38460, 39159, 38461, 39158, 40080, 40081, 40082, 40707, 41151, 41986, 828E0610, 37680, 41080;

19) All Lot Codes: U36524A25, U36524C25, U37527C25, U39413B25, U39847A25, U39847C25, U40279B25, U40456B25, U40754B25, U40754D25, U41429A25, U42439A25, 513E0508, 513G0503, 513h0512, 513J0531, 513k0509, 513L0515, 513M0530, 513A0607, 513A0619, 513B0601, 513D0601, 513E0609, 513F0612, 513F0635, 513G0604, 513D0620, 513E0610, U37349A30, U37349B30, U37527B30, U37943B30, U39413A30, U39847B30, U39847D30, U40279C30, U40456A30, U40754C30, U41169B30, U41429C30, U42999A30, C43454A30, U36524B60, U36524E60, U37527A60, U38947A60, U40279A60, U40456C60, U40754A60, U41169A60, U41429B60, U42439B60, U42999B60, C43454B60, U36524D90, U37349C90, U37943a90, U38947B90, 513D0613, 513F0611, 513G0607;

20) All Lot Codes: U37176A25, U38657A25, U38657D25, U39691A25, U39691D25, U40718A25, U41430C25, U43220A25, U43584A25, 516G0510, 516H0512, 516J0530, 516K0517, 516L0520, 516M0506, 516M0525, 516A0611, 516A0653, 516B0607, 516C0605, 516C0626, 516DO602, 516E0601, 516F0612, 516G0608, 516E0602, U37176B30, U37176C30, U37672B30, U38657B30, U39264A30, U39264C30, U40343A30, U38657E30, U41430A30, U41430D30, U42663B30, U43220B30, U43584B30, U43584C30, U37672A60, U38657C, U39264B60, U39691B60, U39691C60, U40718B60, U41430B60, U42663A60;

21) All Lot Codes: U38324A25, U39692B25, U40748B25, U41436A25, U42664A25, 37230, 519J0531, 519L0507, 519A0602, 519A0611, 519B0606, 519C0623, 519F0616, U38324B30, U38324C30, U39692A30, U40748A30, U41436B30, U42664B30;

22) All Lot Codes: U38566A25, U40594A25, U40594C25, U41398A25, U42516A25, 174k0539, 174L0502, 174M0510, 174A0605, 174C0601, 174F0634, U38566B30, U38566C30, U38566D30, U40594B30, U40594D30, U41398B30, U42516B30;

23) All Lot Codes: U39261A25, U40401B25, U43227A25, U43227B25, U43533B25, U39261B30, U39261C30, U40401A30, U40401C30, U40869A30, U40869B30, C42392A30, C42392B30, U43227C30, U43533A30, U43533C30;

24) All Lot Codes: U37553A25, U37912A25, U38602B25, U37553A30, U37912B30, U38602A30, U38602C30, U40240A30, U40240B30, U41902A30;

25) All Lot Codes: 535H0531, 39055, 40420, 535B0643, 42094, 535F0626;

26) All Lot Codes: 41639, 42696;

27) All Lot Codes: 831k0507, 831K0538, 831M0533, 831A0621, 831B0610, 831B0646, 831C0624, 831D0611, 831F0606, 831F0604, 831G0606, 38114, 38816, 40732, 42178;

28) All Lot Codes: U41166B25, U41591A25, 38151, 182H0518, 182J0514, 182M0533, 40312, 182C0605, 182C0623, 182E0609, 182E0630, U41166A30, U41591B30;

29) All Lot Codes: U38680B25, U38680D25, 38294, 40115, 40384, 041B0607, 41775, U38680A30, U38680C30, U41437A30;

30) All Lot Codes: U40873A25, C40989B25, U41329A25, C42068B25, C42834B25, 998F0512, 998H0508, 998J0501, 998k0506, 998L0516, 998M0507, 998A0617, 998B0629, 998B0634, 998C0612, 998D0620, 998E0617, 998E0622, 998E0625, 998F0616, 998F0641, 998D0619, U38783A30, U39339A30, U39601A30, U38783B30, U39601B30, U40265A30, U39601C30, C40989A30, U41329B30, C42068A30, C42068C30, C42834A30, C43283A30, C42771A30, 998D0606;

31) All Lot Codes: U37783C25, U38732B25, U40339A25, U41699A25, C42375A25, 839G0509, 839M0541, 839A0621, 839B0616, 839B0638, 839C0612, 42120, 839F0613, 839F0614, 839F0641, 42085, , U37783A30, U37783B30, U38732A30, U38732C30, U39378A30, U40339B30, U41450A30, U41699B30, C42375A30, C42376B30, 839D0606;

32) All Lot Codes: U41458B25, 37975, 145L0541, 145B0607, 41741, U41458A30; 

33) All Lot Codes: U37601B25, U37601C25, U38724A25, U38724C25, U40713C25, U41588A25, 053D0505, 053G0519, 053H0523, 053k0524, 053L0511, 39641, 053M0540, 053A0608, 053B0620, 053B0636, U38724B30, U40713A30, U41588C30, U43120A30, U37601A60, U37601D60, U40713B60, U40713D60, U41588B60, U43120B60;

34) All Lot Codes: U39477A25, U39477C25, U40687A25, U413322B25, U41726A25, U42103A25, U39315A30, U39477B30, U39477D30, U40687B30, U41322A30, U41322C30, U41726B30, U42103B30;

35) All Lot Codes: 37974, 38833, 39780, 146A0645, 41703, 42352, U41326A30;
  
36) All Lot Codes: U37951A25, U37951B25, U40398A25, U41624A25, U42742A25, U43269A25, 38627, 961K0524, 961L0518, 961M0525, 961A0641, 961B0606, 961C0622, 961D0616, 961E0614, 961F0616, U37951C30, U39731A30, U40398B30, U40688A30, U41624A30, U42742B30, U43269B30;

37) All Lot Codes: U40691A25, U41595B25, U42741A25, U43170A25, 962H0518, 962J0512, 962L0512, 962M0525, 962A0639, 962B0606, U39606A30, U40440A30, U40691B30, U41590A30, U41595A30, U42741B30, U43170B30;

38) All Lot Codes: U38615A25, U41373A25, U42740A25, U43221A25, 963j0524, 963L0515, 963M0514, 963B0606, U38615B30, U39175A30, U39858B30, U39858A30, U41570A30, U41373B30, U42740B30, U43221B30;

39) All Lot Codes: U43311A25, 40079, 40730, 41500, 964E0614, U42510A30, U42101A30;

40) All Lot Codes: U37145A25, U36526C25, U38776A25, U39937B25, U39937C25, U40208C25, C41881B25, U41459A25, U36526A30, U36526B30, U37145B30, U37564A30, U37564B30, U38481A30, U38776B30, U39267A30, U39937A30, U39937D30, U40208A30, U40208B30, C41881A30, U41459B30;

41) All Lot Codes: 865D0511, 865-H0523, 38817, 865K0507, 39397, 39398, 865M0533, 865A0615, 865C0605, 865B0607, 865C0629, 865E0609, 865F0616;

42) All Lot Codes: 39994, 41987, 43196;

43) All Lot Codes: 552L0546, 42355;

44) All Lot Codes: 37852, 38264, 142A0624;

45) All Lot Codes: U36338B25, U36472B25, U38567B25, U38567D25, U41945A25, U36338A30, U36338D30, U36338C30, U36472A30, U37597A30, U38567A30, U37597B30, U38567C30, U38567E30, U41376A30, U40674A30, U41945B30;

46) All Lot Codes: U38411A25, U39048C25, U39048E25, U40131A25, U40441B25, C40596B25, U41022B25, U41022C25, C42009B25, C42253B25, C42704D25, C43076A25, U38474A30, U39048A30, U39048B30, U39048D30, C39859A30, U40131B30, C40251A30, C40596A30, C41622A30, C42704A30, C43076A30, C43076B30, C43790A30, U38474B60, U38474C60, U38870A60, U38411B60, U38474D60, C39859B60, C40251B60, U40441A60, U40542A60, U41022A60, U41022D60, C41622B60, U41569A60, C42009C60, C42253C60, C42704C60, C42704B60, C43076C60;

47) All Lot Codes: 40421, 654D0601, U41237A30;

48) All Lot Codes: U39342A25, 38265, 38337, 39510, 39958, 40304, 40817, 656C0605, 656E0623, 656F0635, U39342B30, U39342C30, U39342D30, U41249A30;

49) All Lot Codes: 39081, 39993, 40422, 41000, 655C0623, 42691, 655E0628;

50) All Lot Codes: 40572, 41094, R40575R30;

51) All Lot Codes: 40084, 40191, 41773;

52) All Lot Codes: 39791, 42091;

53) All Lot Codes: 39030, 39256, 39925, 43810;

54) All Lot Codes: U40342C25, U41289A25, U40342B30, U40342A30, U40342D30, U40342E30, U41289B30;

55) All Lot Codes: U41626A25;

56) All Lot Codes: 652J0511, 39014, 39394, 652l0533, 652M0541, 652D0624, 652E0610, 652F0601;

57) All Lot Codes: U40809A25, U41523A25, U40242A30, U40809B30, U41523B30;

58) All Lot Codes: U38360A25, U38848A25, U39932B25, U41442A25, 663H0525, 663j0505, 663L0525, 663m0539, 663A0650, 663B0641, 41638, 663C0624, U38360B30, U38781A30, U38848C30, U39071A30, U39412B30, U39932A30, U39932D30, U40289A30, U40289B30, U40356A30, U41168A30, U41442C30, U42107A30, U43026B30, U38360C60, U38848B60, U39412A60, U39932C60, U40356B60, U41442B60, U43026A60;

59) All Lot Codes: 40385, 40846, 42095, 664F0612, 43339, 43811;

60) All Lot Codes: U40400A25, U41427A25, 583k0530, 583A0626, 40816, 583C0623, U40400B30, U40400C30, U41427B30;

61) All Lot Codes: U41995A25, U41995C25, U41995B30;

62) All Lot Codes: U38984A25, U41562A25, U42969A25, U38984B30, U39416A30, U41562B30, U41990A30, U42969B30;

63) All Lot Codes: 39015, 740M0513, 740B0624, 740D0624, 740E0616;
.
64) All Lot Codes: 37865, 39258, 150mo542, 42287, 43208;

65) All Lot Codes: 37312, 37968, 39900, 41559, 43206;

66) All Lot Codes: 37312, 37968, 39900, 41559, 43206;

67) All Lot Codes: 38152, 151H0518, 151k0504, 151C0629, 151F0601;

68) All Lot Codes: U38777B25, U39218B25, U39675D25, U39218G25, U40755A25, U41521B25, U42050A25, C42896B25, C43237B25, C42495D25, U43459A25, U38777A30, U39218B25, U38777C30, U39675A30, U39675B30, U39218C30, U39218D30, U39218F30, U39675E30, U40595B30, U40755B30, U41521C30, U41521D30, C41908A30, C42495A30, C42495B30, C42495C30, C42896A30, C43237A30, U39675C60, U39218E60, U40595A60, U41521A60, C41908B60, C42495E60, C42896C60;

69) All Lot Codes: U36929F25, U37430B25, U37430C25, U37514B25, U37266A25, U38438B25, U39313A25, C39968B25, U40344A25, C42263D25, C42651B25, C43075C25, C43384C25, 256D0503, 256F0520, 256G0501, 256H0503, 256J0504, 256k0538, 256L0514, 256L0529, 256M0542, 256M0547, 256A0619, 256A0649, 256A0658, 256C0609, 256D0601, 256E0608, 256E0614, 256E0631, 256F0640, 256E0602, 256E0632, U36553A30, U36553D30, U36929A30, U36553E30, U36929D30, U37430A30, U37514A30, U37430D30, U38361B30, U38441B, U38441A, U38438A30, U39313B30, U39313C30, U38438D30, U38441E30, U39313E30, C39968A30, U38438F30, U38441F30, U40344C30, C40710, C41511A30, C42263A30, C42650A30, C43075A30, C43384A30, C42650C30, U36553C60, U36929C60, U36929E60, U37514C60, U38361A60, U38438C60, U38441D60, U38438E60, U40344B60, U40344E60, U38441G60, C40710B60, C41511B60, C42263C60, C42651C60, C42650B60, C43075D60, C43384D60, U36553B90, U36929B90, U38441C90, U39313D90, U40344D90, C41511C90, C42263B90, C43075B30, C42651B90, C43384B90, 256D0622;

70) All Lot Codes: U38530A25, U38530E25, U38896A25, U39047A25, U40002A25, U40239A25, U40239B25, C40442C25, U40670A25, U41276B25, U42049B25, C42613B25, C42751B25, C42832B25, C42833B25, 253J0506, 253K0508, 253L0521, 253L0543, 253M0549, 253A0618, 253A0635, 253A0654, 253B0622, 253B0630, 253B0638, 253B0642, 253F0640, 253F0641, 253A0642, 253C0617, 253E0605, U38530C30, U38530D30, U39047B30, U38896C30, U39374A30, U39374B30, U39374D30, U39911A30, U39911B30, U39374F30, C40442, U40670C30, U40670D30, C41287A30, U42049C30, C42347A30, C42613D30, C42613A30, C42751A30, C42833A30, C43265A30, C43418A30, C43470A30, C43418B30, U38530B60, U38896B60, U39374C60, U39374E60, U40439A60, C40442B60, U40439B60, U40670B60, C41287B60, U41276A60, U41276C60, U42049A60, C42347B60, C42613C60, C42751C60, C42832C60, C43265B60, C43470B60, 253D0606, 253F0636, 253F0642;

71)  All Lot Codes: U36928A25, U37525B25, U37525C25, U38778C25, U39726B25, U40714A25, U41370A25, C41754B25, U42441A25, 254E0501, 254F0508, 254G0505, 254H0511, 254J0517, 254k0527, 254k0540, 254L0514, 254M0522, 254A0619, 254A0656, 254B0626, 254C0616, 254D0601, 254D0630, 254F0612, 254E0628, 254F0623, U37267A30, U37267B30, U37525A30, U37525D30, U38513A30, U38778A30, U38513C30, U38778B30, U39726A30, U39880B30, U39880C30, U39726D30, U38778D30, U40714B30, U41370C30, C41754A30, U36928B60, U38513B60, U39726C60, U39880A, U40714C60, U41370B60, C41754C60, U42441B60, 42075;

72) All Lot Codes: U37812R25, U38288R25, U38619R25, U39146R25, U40831A25, U41282A25, U42739A25, U43191A25, U37812R30, U38288R30, U38619R30, U39146R30, U39497A30, U39876A30, U40831B30, U41170A30, U41282B30, U41282C30, U42739B30, U43191B30, U43385A30, U43385B30, U43385C30;

73) All Lot Codes: U42442C60, U43190A60;

74) All Lot Codes: U37952R25, U38321R25, U38618R25, U39147R25, U41171B25, U41281C25, U42086A25, U42627A25, U37952R30,U38321R30, U38618R30, U39147R30, U39964A30, U39964B30, U40387A30, U41171B30, U41281A30, U41281B30, U42086B30, U42627B30, U43174A30, U43174B30, U43386A30, U43386B30;

75) All Lot Codes: U42779B30;

76) All Lot Codes: U39148R25, U40399B25, U41567A25, U39148R30, U39539A30, U40399A30, U41567B30, U41404A30, U42610A30;

77) All Lot Codes: 093j0532, 093L0501, 093A0626, 093B0619, 093C0623, 093C0629, 093E0601, 42711, 093G0606, 093F0608, 42353;

78) All Lot Codes: U38290B25, U38290C25, U38290D25, U40204A25, U40828A25, U41244B25, 37224, 064H0529, 064J0513, 064j0529, 064k0544, 064L0512, 064L0540, 064M0549, 064A0626, 064A0652,064B0616, U38290A30, U38617A30, U38617B30, U38617C30, U39266B30, U39266C30, U40204B30, U40828B30, U41244C30, U41244D30, U42606A30, C43745A30, U39266A60, U40204C60, U41244A60, U42606B60;

79) All Lot Codes: U36825R25, U37248A25, U38014C25, U38682A25, U38682B25, U39265A25, U39671A25, U39987C25, U40130A25, U39987B25, U40130B25, U40130D25, U40827A25, U41090B25, C42579B25, 36872, 37223, 063H0518, 063J0512, 063j0529, 063L0511, 063M0543, 063A0610, 063B0601, U36825R30, U37248A30, U38014A30, U38014B30, U38682C30, U39265B30, U39671B30, U39987A30, U40130C30, U40827B30, U41090A30, U41090C30, C42579C30;

80) All Lot Codes: U38369A25, U39340A25, U39340B25, U40826B25, U42735B25, 709k0505, 709L0519, 709M0503, 709M0535, 709A0618, 709A0654, 41001, 709C0615, 709D0627, 709F0616, 709F0635, U38369B30, U38847A30, U38847B30, U39729A30, U39340C30, U39729B30, U40826A30, U39340D30, U42735A30;

81) All Lot Codes: U38325C25, U38958A25, U38958C25, U39380A25, U41448B25, 834H0535, 834J0534, 834L0521, 834M0503, 834M0509, 834M0524, 834A0628, 834C0623, 834E0601, 834E0622, 834F0616, 834E0623, 834F0623, U38325A30, U38958B30, U39730B30, U39730C30, U40389A30, U41448C30, U42434B30, U38325B60, U39730A60, U39380B60, U40389B60, U41448A60, U42434A60, U43223A60
RECALLING FIRM/MANUFACTURER
Heartland Repack Services LLC, Toledo OH, by telephone between February 14 and February 20, 2007.  Firm initiated recall is ongoing.
REASON
Misbranding. There is the possibility of multiple product packaging mix-ups. An OTC drug, Rx drug, or nutritional supplement other than what is indicated on the product labeling, may be inside the packaging.
VOLUME OF PRODUCT IN COMMERCE
566,734,636 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT
Prasco Fexofenadine Hydrochloride Tablets, 60 mg, 100-count bottles, 48 bottles per case, Rx Only, NDC 66993-107-02, Recall # D-793-2007
CODE
1100743, Exp. 1/31/09; 1100744, Exp. 1/31/09; and 1102674, Exp. 3/19/09
RECALLING FIRM/MANUFACTURER
Sanofi - Aventis US LLC, Kansas City, MO, by letters dated April 2007 via e-mail.  Firm initiated recall is ongoing.
REASON
Labeling Error; some of the labels are missing certain portions of text (strength, tablet count, and/or NDC number).
VOLUME OF PRODUCT IN COMMERCE
78,887/100-tablet bottles
DISTRIBUTION
OH

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT
Mysis Laboratory Blood Bank and Blood Donor Software, Recall # B-0114-07
CODE
Version 6.1 and 6.2
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by e-mail dated July 27, 2006.  Firm initiated recall is ongoing.
REASON
Blood Bank software, containing a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
200 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Mysis Laboratory Blood Bank and Blood Donor Software, Recall # B-0115-07
CODE
Version 6.1 and 6.2
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by e-mail dated August 16, 2006.  Firm initiated recall is ongoing.
REASON
Blood Bank software, containing a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
210 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0421-07
CODE
Unit:  5579247
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone on March 28, 2005. Firm initiated recall is complete.
REASON
Platelets, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0471-07
CODE
Unit: 5578933
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone on January 10, 2005 and by follow-up facsimile transmission on July 5, 2006. Firm initiated recall is complete.
REASON
Platelets, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0513-07
CODE
Unit:  5579153
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone on March 12, 2005 and April 4, 2005. Firm initiated recall is complete.
REASON
Platelets, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
 Mysis Laboratory Blood Bank and Blood Donor Software, Recall # B-0549-07
CODE
Version 6.1 and 6.2
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by e-mail dated November 8, 2006.  Firm initiated recall is ongoing.
REASON
Blood Bank software, containing a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
246 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Mysis Laboratory Blood Bank and Blood Donor Software, Recall # B-0561-07
CODE
Version 6.1 and 6.2
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by e-mail dated November 10, 2006.  Firm initiated recall is ongoing.
REASON
Blood Bank software, containing a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
246 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Platelets, Pheresis Leukocytes Reduced, Recall # B-0729-07
CODE
Units:  5828315 and 5827335
RECALLING FIRM/MANUFACTURER
Life Share Blood Centers, Shreveport, LA, by telephone on April 24, 2006 and by letter on June 2, 2006 and February 1, 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
LA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0851-07
CODE
Units:  71X136037
RECALLING FIRM/MANUFACTURER
Recalling Firm:  LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on January 24, 2005.
Manufacturer:  LifeSouth Community Blood Centers, Inc., Birmingham, AL.  Firm initiated recall is complete.
REASON
Blood products, prepared with insufficient plasma to support the platelet yields, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0861-07
CODE
Units:  4037386 (2 units)
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by facsimile transmissions on June 27, 2005.  Firm initiated recall is complete.
REASON
Platelets, inappropriately prepared by splitting the product into two storage bags instead of one, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets, Recall # B-0917-07
CODE
Units:  7421604, 7421609, 7421612, 7421613, 7421615, 7421616
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by letter dated January 20, 2005. Firm initiated recall is complete.
REASON
Platelets, which did not meet specifications for the required rest time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
OR
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0942-07
CODE
Unit:  71X188894
RECALLING FIRM/MANUFACTURER
Recalling Firm:  LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on February 7, 2005.
Manufacturer:  LifeSouth Community Blood Centers, Inc., Birmingham, AL.  Firm initiated recall is complete.
REASON
Blood product, prepared with insufficient plasma to support the platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0949-07;
b) Platelets, Recall # B-0450-07;
c) Fresh Frozen Plasma, Recall # B-0451-07
CODE
a), b), and c) Unit:  Z119920
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter dated August 31, 2004.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not answer all questions on the health history questionnaire, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Whole Blood CPDA-1, Recall # B-0952-07
CODE
Unit:  22LL32421
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on November 29, 2006, and by letter on December 14, 2006. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from whole blood in which the associated blood component contained clots, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0955-07
CODE
Unit:  5829286
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on April 25, 2006.  Firm initiated recall is complete.
REASON
Blood product, prepared with insufficient plasma to support the platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0979-07
CODE
Unit:  20GY20768
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone on September 10, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MT
___________________________________
PRODUCT
Platelets, Recall # B-1069-07
CODE
Units:  7116152, 7116153, 7216929, 7216930, 7116155, 7216926
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by facsimile transmissions on May 10, 2004.  Firm initiated recall is complete.
REASON
Platelets, which did not meet specifications for the required rest time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
OR
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1085-07;
b) Fresh Frozen Plasma, Cryoprecipitate Reduced, Recall # B-1086-07;      
c) Cryoprecipitated AHF, Recall # B-1087-07;     
d) Recovered Plasma, Recall # B-1088-07     
CODE
a) and c) Units:  7114289, 9703931;
b) Unit:  9703931;
d) Unit:  7114289
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone, facsimile transmissions and e-mails beginning on October 25, 2005.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
LA, MI, WA, and Switzerland
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1089-07;
b) Recovered Plasma, Recall # B-1090-07
CODE
a) and b) Unit:  026FW04563
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Alabama Region, Birmingham, AL, by telephone on February 9, 2006 and by letters dated February 9, 2006.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL and Switzerland
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1091-07;
b) Fresh Frozen Blood, Recall # B-1092-07
CODE
a) and b) Unit:  6151186
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood & Tissue Center, Austin, TX, by facsimile transmissions dated May 18, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had tested RR for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1093-07;
b)  Fresh Frozen Plasma, Recall # B-1094-07
CODE
a) and b) Units:  1711956 and 2332440
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by facsimile transmissions dated February 14, 2005.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose spouse was from an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1209-07
CODE
Units:  1013622, 1017920
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Inc., Jackson, TN, by letter dated August 10, 2006.  Firm initiated recall is complete.
REASON
Red Blood Cells, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. 
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets, Recall # B-1228-07   
CODE
Unit:  4064981
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone, facsimile, and electronic mail beginning August 29, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from donors for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1240-07
CODE
Units:  203121278 and 207272514
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Blood Systems, Inc., Scottsdale, AR, by email on January 3, 2006. 
Manufacturing Firm:  Blood Systems, Inc., Lafayette, LA.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Source Plasma, Recall # B-1241-07
CODE
Units:  I72054338, I72054114, I72053650, I72053124, I72052275, I72049431, I72048890, I72048505, I72043932, I72043021, I72042786, I72042178, I72041414, I72041150, I72040877
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Fort Worth, TX, by facsimile on August 2, 2006.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
NC
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1242-07;     
b) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1243-07;             
c) Platelets, Recall # B-1244-07;
d) Fresh Frozen Plasma, Recall # B-1245-07;
e) Recovered Plasma, Recall # B-1246-07
CODE
a) Units:  1017339, 0980991;
b) and c) Unit:  0745446;
d) Unit:  0980991;
e) Units:  1017339, 0745446
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, St. Paul, MN, by facsimile on September 11, 2003 or by letter dated September 12, 2003.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in an area with increased risk for human immunodeficiency virus (HIV) Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MN, NY, and Switzerland
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1256-07
CODE
Units:  W001304220045, W001304220046, W001304220047, W001304200508, W001304200511, W001304200529, W001304200541AO, W001304200545, W001304200563AO, W001304200564, W001304200565, W001304200568, W001304200571AO, W001304200650, W001304200581, W001304200582, W001304200592, W001304200598BO, W001304200600, W001304200604, W001304200607, W001304200613AO, W001304200616AO, W001304200616BO, W001304200617, W001304200620BO, W001304200624, W001304200628, W001304200571BO, W001304200596, W001304200629, W001304200630, W001304200633, W001304200634, W001304200641, W001304200647, W001304200648, W001304200649, W001304200613BO, W001304200626, W001304200636CO, W001304200609
RECALLING FIRM/MANUFACTURER
Department of the Air Force, Lackland Air Force Base, TX, by e-mail and facsimile transmission dated November 17, 2004.  Firm initiated recall is complete.
REASON
Platelets, lacking quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
42 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1260-07
CODE
Unit:  04FK66165
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New England Region, Dedham, MA, by facsimile transmission dated October 26, 2006.  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
DISTRIBUTION
MA
___________________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1261-07
CODE
Units:  041FQ12130 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Alabama Region,Birmingham, AL, by telephone on July 17, 2006 and by letter dated July 24, 2006.  Firm initiated recall is complete. 
REASON
Blood products, collected from a donor who was involved in a possible transfusion-transmitted hepatitis infection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1262-07;
b) Cryoprecipitated AHF, Recall # B-1263-07;
c) Plasma, Frozen, Cryoprecipitate Reduced, Recall # B-1264-07
CODE
a), b), and c) Unit:  20312-2328 
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Blood Systems, Inc., Scottsdale, AZ, by telephone, e-mail, and letter beginning September 14, 2005.
Manufacturer:  Blood Systems, Inc., Lafayette, LA.  Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor who was subsequently determined to have a history of testing positive for Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
LA and Switzerland

___________________________________
PRODUCT
 Autologous Blood Processing Devices:
a) 800-0503A  GPS Mini Platelet Concentrate Separation Kit with 30mL
    ACD-A, Recall # B-1269-07;
b) 800-0504A GPS Mini Platelet Concentrate Separation Kit with 50ML
    ACD-A, Recall # B-1270-07;
c) 800-0515 Plasmax Plus Plasma Concentrator with GPS II and 50ML
    ACD-A, Recall # B-1271-07;
d) 800-1001A GPS II Platelet Concentrate Separation Kit 50mL
    ACD-A, Recall # B-1272-07;
e) 800-1002A GPS II Platelet Concentrate Separation Kit 50mL
    ACD-A Double, Recall # B-1273-07;
f) 800-0501 Plasmax Plasma Concentrator with GPS Mini and 50mL
    ACD-A, Recall # B-1274-07;
International Distribution Only:
g) 800-0621A  GPS II Double Unit with Syringes 30mL ACD-A,
    Recall # B-1275-07;
h) 800-0650  Recover Mini Platelet Separation Kit 30mL ACD-A,
    Recall # B-1276-07;
i) 800-0721A  GPS II Single Unit with Syringes 30mL ACD-A,
   Recall # B-1277-07;
j) 800-0921 GPS II Single Unit with Syringes, Recall # B-1278-07
CODE
a) Lots 907540, 910980, 910990, 911000;
b) Lots 910950, 910960, 910970, 932920, 932930, 932940;
c) Lot 965030;
d) Lots 910750, 910760, 910770, 910780, 932550, 932560,
    932570, 932580, 932600, 932610, 932620, 932630, 932640,
    932650, 932660, 932670, 932680, 932690, 932700, 932710, 932720;
e) Lots 932510, 932520, 932530, 932540;
f) Lots 878630, 878640, 878650, 878660, 878670, 932950,
    932970, 932980, 932990, 945260;
g) Lots 910910, 910920;
h) Lot 916550;
i) Lot 910800;
j) Lots 933020, 945410
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated March 5, 2007.  Firm initiated recall is ongoing.
REASON
Autologous blood processing devices, with a potential lack of assurance of sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,291 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1279-07;
b) Fresh Frozen Plasma, Recall # B-1280-07;
c) Platelets Leukocytes Reduced, Recall # B-1281-07  
CODE
a), b), and c) Unit:  LL50560
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, BA Rhode Island blood Center, Providence, RI, by telephone and follow up letter on January 19, 2007.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MA and NY
___________________________________
PRODUCT
Red Blood Cells Apheresis Leukocytes Reduced, Recall # B-1282-07  
CODE
Units:  LM24475 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, DBA Rhode Island blood Center, Providence, RI, by telephone and follow up letter on January 25, 2007.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MA
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1299-07;
b) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1300-07;
c) Red Blood Cells, Apheresis, Leukocytes Reduced,  Recall # B-1301-07;
d) Fresh Frozen Plasma, Recall # B-1302-07
CODE
a) Units:  16382-8794, 16382-9657, 16382-9658, 16382-9659, 16382-9707, 16382-9716, 16382-9729, 16382-9745, 16382-9763, 16383-3251, 16383-3253, 16383-3254, 16383-3257, 16383-6347, 16383-6348, 16383-6358, 16383-6417, 16383-6419, 16383-6423, 16383-6460, 16383-6477, 16383-6478, 16383-6479, 16383-6481, 16383-6485, 16383-6489, 16383-6492, 16383-6542, 16383-6700, 16383-6703, 16383-6707, 16383-6710, 16383-6822, 16383-6987, 16383-6988, 16383-7001, 16383-7003, 16383-7010, 16383-7013, 16383-7018, 16383-7019, 16383-7063, 16383-7064, 16383-7065, 16383-7067, 16383-7070, 16383-7071, 16383-7072, 16383-7073, 16383-7074, 16383-7075, 16383-7082, 16383-7085, 16383-7091, 16383-7098, 16383-7100, 16383-7103, 16383-7130, 16383-7135, 16383-7150, 16383-7153, 16383-7160, 16383-7180, 16383-7185, 16383-7190, 16383-7193, 16383-7196, 16383-7199, 16383-7247, 16383-7257, 16383-7262, 16383-7269, 16383-7271, 16383-7279, 16383-7281, 16383-7324, 16383-7325, 16383-7329, 16383-7405, 16383-7427, 16383-7454, 16383-7456, 16383-7461, 16383-7464, 16383-7487, 16383-7489, 16383-7490, 16383-7491, 16383-7555, 16383-7581, 16383-7584, 16383-7587, 16383-7589, 16383-7591, 16383-7593, 16383-7596, 16383-7597, 16383-7864, 16383-7882, 16383-7902, 16383-7922, 16383-7943, 16383-8078, 16383-8091, 16383-8093, 16383-8200, 16383-8499, 16383-8500, 16383-8507, 16383-8508, 16383-8512, 16383-8515, 16383-8541, 16383-8554, 16383-8814, and 16383-8816;
b) Unit:  16383-7919;
c) Units:  16383-6361 (2 units), 16383-6415 (2 units), 16383-6446 (2 units),
    16383-6483 (2 units), 16383-6537 (2 units), 16383-6538 (2 units),
    16383-6545, 16383-6826 (2 units), 16383-6977 (2 units), 16383-6979 (2 units),
    16383-7094 (2 units), 16383-7133 (2 units), 16383-7294 (2 units),
    16383-7410 (2 units), 16383-7819 (2 units), 16383-7826 (2 units),
    16383-7855 (2 units), 16383-8539, 16383-8543 (2 units), 16383-8547 (2 units);
d) Units:  16380-9592, 16381-0426, 16381-0584, 16381-0585, 16381-0587,
    16381-1139, 16381-1200, 16381-1774, 16381-1954, 16381-1960, 16381-2114,
    16381-2116, 16381-2199, 16381-2318, 16381-4402, 16381-4404, 16381-4728,
    16381-8237, 16381-8242, 16381-8243, 16381-8244, 16381-8246, 16382-0160,
    16382-0162, 16382-0177, 16382-0415, 16382-0634, 16382-0636, 16382-0646,
    16382-0648, 16382-0654, 16382-0756, 16382-1093, 16382-1200, 16382-1218,
    16382-1221, 16382-1222, 16382-1223, 16382-1238, 16382-1244, 16382-1247,
    16382-1250, 16382-1254, 16382-1330, 16382-1385, 16382-1389, 16382-1556,
    16382-1581, 16382-1582, 16382-1590, 16382-1591, 16382-1592, 16382-1670,
    16382-1677, 16382-1714, 16382-1722, 16382-1797, 16382-2027, 16382-2033,
    16382-2036, 16382-2055, 16382-2068, 16382-2250, 16382-2441, 16382-2445,
    16382-2455, 16382-2457, 16382-4545, 16382-4610, 16382-4624, 16382-4739,
    16382-4749, 16382-4791, 16382-6031, 16382-6747, 16382-6750, 16382-6751,
    16382-6757, 16382-6773, 16382-6811, 16382-6971, 16382-7166, 16382-7167,
    16382-7859, 16382-8432, 16382-8462, 16382-8726, 16382-8731, 16382-8794,
    16382-9032, 16382-9041, 16382-9115, 16382-9125, 16382-9369, 16382-9371,
    16382-9451, 16382-9453, 16382-9473, 16383-6348, 16383-6417, 16383-6460,
    16383-6485, 16383-6492, 16383-6542, 16383-6703, 16383-6707, 16383-6710,
    and 16383-6996.
RECALLING FIRM/MANUFACTURER
United Blood Services, Meridian, MS, by telephone and e-mail on July 11, 2005.  Firm initiated recall is ongoing.
REASON
Blood products, collected from donors who may have received inappropriate arm preparation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
284 units
DISTRIBUTION
AL, MS, and UK
___________________________________
PRODUCT
Platelets, Pheresis Leukocytes Reduced, Recall # B-1303-07
CODE
Units:  5828867, 5827950 (2 units), 5827086, 5825508, 5788342, 5787670, 5787514 and 5827753
RECALLING FIRM/MANUFACTURER
Life Share Blood Centers, Shreveport, LA, by telephone on April 17, 2006 and by letter on June 2, 2006. 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
9 units
DISTRIBUTION
LA, TX, and NY
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1304-07;
b) Plasma Frozen, Recall # B-1305-07 
 CODE
a) Units:  21GE58301, 21GE58302, 21GE58304, 21GE58306,
    21GE58308, 21GE58311, 21GE58312, 21GE58313, 21GE58316,
    21GE58318, 21GE58320, 21GE58321, 21GE58323, 21GE58332,
    21GE58334, 21GE58340, 21GE58342, and 21GE58346;
b) Units:  21GE58316 and 21GE58320
RECALLING FIRM/MANUFACTURER
American National Red Cross, Pacific Northwest Region,Portland, OR, by telephone on January 5, 2005 and January 7, 2005 and by letter on January 12, 2005. Firm initiataed recall is complete.
REASON
Blood products, collected from donors whose arm scrubs may have been incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
CA, OR, and WA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1308-07
CODE
Unit:  040P13070
RECALLING FIRM/MANUFACTURER
American National Red Cross, Heart of American Region, Peoria, IL, by telephone on December 19, 2006 and by letter dated December 27, 2006.  Firm initiated recall is complete.
REASON
Blood product, collected in an apheresis collection kit that may have exceeded the acceptable time period for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1310-07
CODE
Unit:  04GR35146 (Part 1)
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by facsimile on November 30, 2006.  Firm initiated recall is complete.
REASON
Blood product, with a low platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT
Source Plasma, Recall # B-1313-07
CODE
Units:  0410040382, 0410040713, 0410041084, 0410041293, 0410041608, 0410041815, 0410041938, 0410042100, 0410042218, 0410042379, 0410042475, 0410042623, 0410042702, 0410042859, 0410042945, 0410043090
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on October 13, 2006.  Firm initiated recall is complete.
REASON
Blood products, which tested negative for viral markers, but were collected from a donor who was previously deferred for a positive viral marker test, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
Spain
___________________________________
PRODUCT
Cryoprecipitated AHF, Pooled, Recall # B-01317-07
CODE
Units (2 pooled Cryoprecipitated AHF)   Pool unit numbers KR01554 (containing GR45441, KC16569, KZ88552, KC16464) and KR01508 (containing FJ96361 and KC16477)
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on June 16, 2003.  Firm initiated recall is complete.
REASON
Blood products, which were not refrozen within one hour of preparation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1318-07;
b) Recovered Plasma, Recall # B-1319-07    
CODE
a) and b) Units:  614759 and 1617589
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood Tissue CenterAustin, TX, by letter dated June 23, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in deferral status, were distributed
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX, FL, and Switzerland
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1320-07
CODE
Units:  030FN07227, 030FN07230, 030FN07236 and 030FN07247
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on November 10, 2006 and by letter November 15, 2006.
REASON
Blood products, which did not meet the quality control requirements for distribution, were distributed
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OK and MD

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0941-07
CODE
Units:  7787165 (split product)
RECALLING FIRM/MANUFACTURER
Life Source, Glenview, IL, by telephone on December 11, 2006.  Firm initiated recall is complete.
REASON
Blood products, labeled “leukoreduced” but which were not tested to verify the white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Platelets, Recall # B-1229-07    
CODE
Unit:  4064461
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone, facsimile, and electronic mail beginning August 29, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from donors for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1236-07;
b) Platelets, Pooled, Recall # B-1237-07
CODE
a) Unit:  KQ55908;
b) Units:  P26695 (KQ55878, KQ55879, KQ55880, KQ55904),
    P26698 (KQ55890, KQ55891, KQ55892, KQ55894, KQ55896, KQ55907) and
    P26717 (KQ55895, KQ55893, KQ55897, KQ55898, KQ55900, KQ55905)        
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on July 14, 2003.  Firm initiated recall is complete.
REASON
Blood products, which may have reached unacceptable temperatures during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Platelet Pheresis, Recall # B-1238-07
CODE
Units:  22LE18108 (parts 1 and 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on October 24, 2006 and by letter dated November 1, 2006.  Firm initiated recall is complete.
REASON
Blood products, collected using automated equipment that was not validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1265-07;
b) Plasma, Frozen, Recall # B-1266-07;    
c) Recovered Plasma, Recall # B-1267-07   
CODE
a) Units:  21FS27292, 21FS29126, 21FS30031, 21FS34397, 21FZ08393;
b) Units:  21FS30031, 21FS34397;
c) Units:  21FS27292, 21FS29126
RECALLING FIRM/MANUFACTURER
American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone and electronic notification on June 2, 2005 and by letters dated between June 8 and 15, 2005. 
REASON
Blood products, which tested negative for Hepatitis B surface antigen (HBsAg) and for the antibody to Hepatitis B core antigen (anti-HBc), but were collected from a donor who previously tested positive for HBsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
OR and CA
___________________________________
PRODUCT
 Platelets Pheresis, Leukocytes Reduced, Recall # B-1268-07
CODE
Units:  041FP52395 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Alabama Region, Birmingham, AL, by telephone on August 29, 2006 and by letter dated September 18, 2006.  Firm initiated recall is complete.
REASON
Blood products, mislabeled as crossmatch compatible, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced, Recall # B-1283-07;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1284-07
CODE
a) Unit:  21FP12467;
b) Units:  21KP08121, 21P86715 (2 units), 21P83001
RECALLING FIRM/MANUFACTURER
American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on June 1, 2004 and by letter dated June 10, 2004. Firm
REASON
Blood products, which were mislabeled as to HLA type, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
ID, OR, and WA
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1285-07
CODE
Unit:  41FE25673
RECALLING FIRM/MANUFACTURER
American National Red Cross, Alabama Region, Birmingham, AL, by telephone on June 16, 2005 and by letter dated June 23, 2005.  Firm initiated recall is complete.
REASON
Blood product, for which antigen testing was performed incorrectly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1286-07
CODE
Units:  1014151, 1031004, 1031005
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, St. Paul, MN, by letter dated July 22, 2003.  Firm initiated recall is complete.
REASON
Blood products, which were not refrigerated within eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MN and WI
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1287-07
CODE
Unit:  01GK37248
RECALLING FIRM/MANUFACTURER
American National Red Cross, Alabama Region, Birmingham, AL, by telephone on October 15 and 17, 2005 and by letter dated October 19,, 2005.  Firm initiated recall is complete.
REASON
Blood product, for which there was no documentation for the time period out of controlled storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1288-07
CODE
Units:  41GQ12567, 26FV94051, 26FF52585
RECALLING FIRM/MANUFACTURER
American National Red Cross, Alabama Region, Birmingham, AL, by telephone on June 9, 2003 and by letter dated June 12,, 2003.  Firm initiated recall is complete.
REASON
Blood product, for which there was no documentation for the time period out of controlled storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1289-07
CODE
Units:  2879025260 (part 1), 2879025270 (part 1), 2879025271 (parts 1 & 2), 2879025276 (part 1), 2879025278 (part 1)
RECALLING FIRM/MANUFACTURER
Recalling Firm:  American National Red Cross, Alabama Region, Birmingham, AL, by telephone on March 28, 2005 or April 14, 2005 and by letter dated April 7, 2005.
Manufacturer:  American National Red Cross, Gulf Coast Region, Mobile, AL.  Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
AL
___________________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced, Recall # B-1306-07;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1307-07
CODE    
a) Units:  21FP22074, 21FP22128, 21FP22161, 21KP63091, 21KP62917,
    21KP62683, 21KP63483, 21KP62773, 21KP62813, 21KP63026 (2 units),
    21KP62877, 21KP62576;
b) Units:  21FP22161, 21KP62917, 21KP62773, 21KP62877
RECALLING FIRM/MANUFACTURER
American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on October 4, 2004 and by letters dated October 18, 2004 or October 22, 2004.  Firm initiated recall is complete.
REASON
Blood products, possibly collected without the entire amount of anticoagulant solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
OR, PA, and WA
___________________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1309-07
CODE
Units:  04GE03317 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by letter dated November 29, 2006.  Firm initiated recall is complete.
REASON
Blood products, for which documentation of the apheresis procedure was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
 Red Cross Cells, Leukocytes Reduced, Recall # B-1311-07
CODE
Unit:  004R56212
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by telephone on November 21, 2006 and by letter dated November 22, 2006.  Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect antibody identification, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1312-07
CODE
Unit:  1079504
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, St. Paul, MN, by telephone on August 12, 2003.  Firm initiated recall is complete.
REASON
Blood product, which was untested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Source Plasma, Recall # B-1314-07    
CODE
Units:  381007521, 381008593, 381008290, 381007994, 381007735, 381007319, 381007041, 381006748, 381005966, 381005670, 381005301, 381005087, 381004734, 381004565, 381004112, 381003957, 381003552, 381003174, 381002917, 381002610, 381000832, 381000752, 381002125, I55043605, I55043357, I55043006, I55042821, I55038944, I55038651, I55038223, I55037866, I55041799, I55041580, 381007151, 381006887, 381006582, 381005786, 381005506, 381005189, 381004932, 381004653, 381004331, 381004020, 381003690, 381003417, 381003114, 381002831, 381002509, 381001204, 381000868, 381000558, 381002227, 381001926, 381001605, I55043422, I55042600, I55038755, I55038466, I55038159, I55037885, I55037647, I55041862, I55041601, I55041342, 381008850, 381008407, 381008122, 381007814, 381007270, 381007056, 381005603, 381005412, 381005020, 381004779, 381003708, 381003208, 381001498, 381001307, 381002364, 381001576, I55043289, I55043098, I55042524, I55038918, I55038404, I55038312, I55037842, I55037731, I55041798, I55041451, 381008882, 381008543, 381008226, 381007861, 381007576, 381007214, 381006997, 381005991, 381005834, 381001532, I55043322, I55043039, I55042817, I55038983, 381008433, 381008251, 381007771, 381007147, 381006991, 381005977, 381005945, 381005357, 381005121, 381004775, 381004542, 381004168, 381003963, 381003531, 381003314, 381002685, 381001441, 381001036, 381000798, 381001844, 381001677, I55043168, I55042866, 155038849, 155038577, I55038320, I55037910, 381008710, 381008273, 381008099, 381007696, 381007473, 381007021, 381006843, 381005953, 381005778, 381005364, 381005186, 381004811, 381004628, 381004183, 381004001, 381003579, 381002888, 381002663, 381001285, 381001068, 381000665, 381002428, 381001943, 381001722, I55043069, I55042935, I55042512, I55038579, I55038395, I55037691, I55037556, I55041642, I55041536, 381008865, 381008602, 381008234, 381007739, 381007457, 381007066, 381006909, 381005974, 381005277, 381005123, 381004732, 381004503, 381004117, 381003950, 381002817, 381002581, 381000867, 381002236, 381001539, I55043552, I55043084, I55042982, I55042506, I55038926, I55038397, I55038300, I55037810, I55037740, I55041786, I55041670, 381008846, 381008468, 381008121, 381007336, 381007131, 381006724, 381006544, 381005641, 381005457, 381004714, 381004514, 381004098, 381003927, 381003523, 381003344, 381002929, 381002699, 381000105, 381000077, 381008565, 381008281, 381007977, 381007721, 381007390, 381007020, 381006745, 381006529, 381005699, 381005411, 381005108, 381004806, 381004497, 381004192, 381003857, 381003613, 381003285, 381002997, 381002721, 381001389, 381001126, 381000701, 381002437, I55043545, I55043224, I55042962, I55042699, I55038847, I55038453, I55038244, I55037895, I55037685, I55041783, I55041539, 381008821, 381008329, 381008160, 381007710, 381007636, 381007053, 381006956, 381005839, 381005407, 381005321, 381004845, 381004777, 381004195, 381004019, 381003233, 381002912, 381001392, 381001327, 381000667, 381002441, 381002062, 381001817, I55043572, I55043221, I55042839, I55042598, I55038771, I55038363, I55038104, I55037799, I55041941, I55041751, I55041448, 381008864, 381008600, 381007740, 381007614, 381007068, 381007506, 381005998, 381005866, 381005384, 381005073, 381004817, 381004504, 381004205, 381003897, 381003618, 381002764, 381001163, 381000623, 381002408, 381001983, 381001767, I55043481, I55043133, I55042881, I55042622, I55038752, I55038509, I55038157, I55037900, I55037604, I55041845, I55041595, I55041385, 381001545, 381005719, 381008727, 381008263, 381008056, 381007682, 381007269, 381006967, 381006708, 381005600, 381005036, 381004843, 381004242, 381004025, 381003321, 381002680, 381001338, 381001123, 381002481, 381002265, 381001860, 381001647, I55043216, I55043027, I55041779, 381008781, 381008310, 381008260, 381007704, 381007669, 381007073, 381007512, 381006513, 381005934, I55043351, I55043100, I55042791, I55038742, I55038599, I55038153, I55037938, I55037558, I55041872, I55041543, 381002748
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Peoria, IL, by telephone between December 21, 2006 and January 6, 2007.  Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
358 units
DISTRIBUTION
NC
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1315-07;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1316-07
CODE
a) Unit:  22KZ30762
b) Unit 22KT29805
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter on November 15, 2006.
REASON
Blood products, collected from an unsuitable donor due to a history of Hemochromatosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with software  version 3.x and 4.11; identification numbers 1505-9000-000 and M1057699 (upgrade), Recall # Z-0784-2007
CODE
Serial numbers: CBCH00101, CBCH00110, CBCJ00135, CBCJ00136, CBCJ00207, CBCJ00472, CBCJ00623, CBCJ00685, CBCJ00686, CBCJ00688 thruCBCJ00702, CBCK00100, CBCK00101 thru CBCK00208, CBCK00210 thru CBCK00269, CBCK00271 thru CBCK00298, CBCK00301 thru CBCK00516, CBCK00519 thru CBCK00526, CBCK00535
RECALLING FIRM/MANUFACTURER
Datex – Ohmeda, Inc, Madison, WI, by letter on February 2, 2007. Firm initiated recall is ongoing.
REASON
There are two unique conditions with the Engstrom Carestation that require corrective action. These include an anomaly in the control of the safety relief valve and a situation where the display unit may reset.
VOLUME OF PRODUCT IN COMMERCE
449 units
DISTRIBUTION
GA, RI, WI, and TX
___________________________________
PRODUCT
CIBASoft® Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9, Expiration 2011-10, Recall # Z-0793-2007
CODE
Lot #41074100201110
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Ciba Vision Corporation, Duluth, GA, by letter on April 30, 2007 and May 2, 2007.
Manufacturer:  Ciba Vision Puerto Rico, Inc, Cidra, PR.  Firm initiated recall is ongoing.
REASON
Base curve of the lenses does not meet specification.
VOLUME OF PRODUCT IN COMMERCE
22 lenses
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland, Recall # Z-0795-2007
CODE
Lot Number 2990052 2007-12
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Ethicon, Inc, Somerville, NJ, by letter on April 20, 2007.
Manufacturer:  Ethicon SARL, Neuchatel, Switzerland. Firm initiated recall is ongoing.
REASON
The pre-printed outer box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor System (Product Code PFRT01). The contents of the box actually contain GYNECARE PROLIFT Anterior Pelvic Floor System (Product Code PFRA01)
VOLUME OF PRODUCT IN COMMERCE
60 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Maxi Move Patient Lift with Scale; Model KMBB4ELU2FUS, Recall # Z-0796-2007;
b) Maxi Move Patient Lift with Scale; Model KMBB4MSU2FUS, Recall # Z-0797-2007;
c) Maxi Move Patient Lift with Scale; Model KMBB4OLU2FUS, Recall # Z-0798-2007;
d) Maxi Move Patient Lift with Scale; Model KMBB4OSU2FUS, Recall # Z-0799-2007
CODE
a) Serial numbers:  SEE0624509, SEE0624510, SEE0624511, SEE0624512, SEE0624513, SEE0624514, SEE0624515;

b) Serial numbers:  SEE0628311, SEE0628312, SEE0628314, SEE0628315, SEE0628319, SEE0628320, SEE0628322, SEE0628323, SEE0628324, SEE0628326;

c) Serial numbers:  SEE0624160, SEE0624161, SEE0624162, SEE0624163, SEE0624164, SEE0624165, SEE0624166, SEE0624167, SEE0624168, SEE0624169, SEE0624170, SEE0624171, SEE0624172, SEE0624173, SEE0624174, SEE0624175, SEE0624177, SEE0624178, SEE0624179, SEE0624180, SEE0624181, SEE0624182, SEE0624183, SEE0624184, SEE0624185, SEE0624186, SEE0624187, SEE0624188, SEE0624189, SEE0624190, SEE0624191, SEE0624192, SEE0624193, SEE0624194, SEE0624195, SEE0624196, SEE0624197, SEE0624198, SEE0624199, SEE0624200, SEE0624201, SEE0624202, SEE0624203, SEE0624204, SEE0624205, SEE0624206, SEE0624207, SEE0624208, SEE0624209, SEE0624210, SEE0624211, SEE0624212, SEE0624213, SEE0624214, SEE0624215, SEE0624216, SEE0624217, SEE0624218, SEE0624219, SEE0624220, SEE0624221, SEE0624222, SEE0624223, SEE0624224, SEE0624225, SEE0624226, SEE0624227, SEE0624228, SEE0624229, SEE0624230, SEE0624231, SEE0624233, SEE0624234, SEE0624235, SEE0624236, SEE0624237, SEE0624238, SEE0624239, SEE0624240, SEE0624567, SEE0624568, SEE0624569, SEE0624570, SEE0624571, SEE0624572, SEE0624573, SEE0624574, SEE0624575, SEE0624576, SEE0624577, SEE0624578, SEE0624579, SEE0624580, SEE0624581, SEE0624582, SEE0624583, SEE0624584, SEE0624585, SEE0624586, SEE0624587, SEE0624588, SEE0624589, SEE0624591, SEE0624592, SEE0624593, SEE0624594, SEE0624595, SEE0624596, SEE0624597, SEE0624598, SEE0624599, SEE0624600, SEE0624601, SEE0624602, SEE0624603, SEE0624604, SEE0624605, SEE0624606, SEE0624607, SEE0624608, SEE0624609, SEE0624610, SEE0624611, SEE0624612, SEE0624613, SEE0624614, SEE0624615, SEE0624616, SEE0624617, SEE0624618, SEE0624619, SEE0624621, SEE0624622, SEE0624623, SEE0624624, SEE0624625, SEE0624626, SEE0624628, SEE0624629, SEE0624630, SEE0624631, SEE0624632, SEE0624633, SEE0624634, SEE0624635, SEE0624636;

d) Serial numbers:  SEE0627469, SEE0627470, SEE0627471, SEE0627472, SEE0627473, SEE0627474, SEE0627476, SEE0627477, SEE0627478, SEE0627480, SEE0627481, SEE0627482, SEE0627483, SEE0627484, SEE0627485, SEE0627486, SEE0627487, SEE0627488, SEE0627489, SEE0627490, SEE0627491, SEE0627492, SEE0627493, SEE0627494, SEE0627495, SEE0627496, SEE0627498, SEE0627499, SEE0627500, SEE0627501, SEE0627502, SEE0627503, SEE0627504, SEE0627505, SEE0627506, SEE0627507, SEE0627508, SEE0627509, SEE0627510, SEE0627511, SEE0627512, SEE0627513, SEE0627514, SEE0627515, SEE0627516, SEE0627517, SEE0627518, SEE0627519, SEE0627520, SEE0627521, SEE0627522, SEE0627523, SEE0627524, SEE0627526, SEE0627527, SEE0627528, SEE0627529, SEE0627530, SEE0627531, SEE0627532, SEE0627533, SEE0627534, SEE0627535, SEE0627536, SEE0627537, SEE0627538, SEE0627539, SEE0627540, SEE0627541, SEE0627542, SEE0627543, SEE0627544, SEE0628342, SEE0628343, SEE0628344, SEE0628345, SEE0628346, SEE0628347, SEE0628348, SEE0628349, SEE0628350, SEE0628351, SEE0628352, SEE0628353, SEE0628354, SEE0628355, SEE0628356, SEE0628357, SEE0628358, SEE0628359, SEE0628360, SEE0628361, SEE0628362, SEE0628363, SEE0628364, SEE0628365, SEE0628366, SEE0628367, SEE0628368, SEE0628369, SEE0628370, SEE0628371, SEE0628372, SEE0628373, SEE0628374, SEE0628375, SEE0628376, SEE0628377, SEE0628378, SEE0628379, SEE0628381, SEE0628382, SEE0628383, SEE0628386, SEE0628388, SEE0628391, SEE0628399, SEE0628401, SEE0628402, SEE0628403, SEE0628404
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Arjo, Inc, Roselle, IL, by letters dated January 5, 2007.
Manufacturer:  Arjo Hospital Equipment, Esloev, Sweden.  Firm initiated recall is ongoing.
REASON
The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting on the two bolts holding the scale in place.
VOLUME OF PRODUCT IN COMMERCE
284 lifts
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, is a radiopaque , color stable light-cured resin cement indicated for bonding veneers fabricated of porcelainor composite, Recall # Z-0800-2007
CODE
Lot 20070124 on box/bag, 7CG code on syringe
RECALLING FIRM/MANUFACTURER
3M Espe Dental Products, Irvine, CA, by telephone or email starting on February 12, 2007. Firm initiated recall is ongoing.
REASON
Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected.
VOLUME OF PRODUCT IN COMMERCE
99 units
DISTRIBUTION
IN, PA, NY, CA, NV, AZ, and Malaysia

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

___________________________________
PRODUCT
Boston Scientific Medi-Tech Stainless Steel Greenfield Vena Cava Filter, order #50-400, Recall # Z-0794-2007
CODE
Lot #7826572
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Boston Scientific, Maple Grove, MN, by letter on October 6, 2006.
Manufacturer:  Boston Scientific Cork, Ltd, Cork, Ireland.  Firm initiated recall is complete.
REASON
One lot of product, Stainless Steel Greenfield Vena Cava Filter, may have the incorrect expiration date of 2008-07 and the correct date is 2008-06.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Biohorizons 3 0mm Overdenture Implant System, REF 30120S2, (3 mm x 12 mm-2mm collar), Recall # Z-0801-2007
CODE
Lot:  S0207053
RECALLING FIRM/MANUFACTURER
BioHorizons Implant Systems, Inc, Birmingham, AL, by letters on April 18, 2007.  Firm initiated recall is ongoing.
REASON
Dental implant system is missing ball attachment system.
VOLUME OF PRODUCT IN COMMERCE
34 units
DISTRIBUTION
Nationwide and Italy

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINE - CLASS I

___________________________________
PRODUCT
Beef Pizzle dog chew. Label includes ''American Bullie A.B. Dog Chew Medium Made from All American Beef Pizzle. Distributed by T.W. Enterprises Inc., Ferndale, WA 98248'' where all sizes are included. The firm manufactures the following products/sizes: 6 inch/dog chew Medium; 10 inch/dog chew large; 13 inch/dog chew XL; 16 inch/dog chew mega; 26 inch/dog chew jumbo; 3-4 inch/puppy chew and 4-6 inch/puppy chew. Each chew is individually heat shrink wrapped in clear polypropelene plastic with multicolored label. Recall # V-032-2007
CODE
Product contains no manufacturing or lot codes.
RECALLING FIRM/MANUFACTURER
T.W. Enterprises, INC, Ferndale, WA, by telephone on April 2, 2007 and follow up letter on April 10, 2007.  Firm initiated recall is ongoing.
REASON
Product contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
12,463 units
DISTRIBUTION
CA, WA, PA, IL, and OR

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINE - CLASS II

*****CORRECTION*****

In the May 9, 2007 (07-19) Enforcement Report, Recall # V-034-2007, Fort Dodge Aureomycin Chlortetracycline Powder was reported as a Class II recall and is classified as a Class III recall. 

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINE - CLASS III

___________________________________
PRODUCT
a) Muscle Pig IV CSP Medicated, A Complete Starter Feed for Baby
    Pigs, labeled as containing 100 g/ton chlortetracycline, 0.011% sulfathiazole,
    and 50 g/ton penicillin (as procaine), packaged in 50-lb. bags, 7-day
    withdrawal period. Recall # V-037-2007;
b) Bulk Muscle Pig III CSP Medicated, A Complete Starter Feed for Baby Pigs,
    labeled as containing 100 g/ton chlortetracycline, 0.011% sulfathiazole,
    and 50 g/ton penicillin (as procaine), 7-day withdrawal period.
    Recall # V-038-2007
CODE
a) Requisition (batch) 669;
b) Requisition (batch) 711
RECALLING FIRM/MANUFACTURER
Recalling Firm: MFA Inc, Columbia, MO, by telephone on April 10, 2007.
Manufacturer: MFA Inc, Gerald, MO.  Firm initiated recall is complete.
REASON
The product is mislabeled as containing sulfathiazole, but it actually contains sulfamethazine
VOLUME OF PRODUCT IN COMMERCE
20/50-lb. bags Muscle Pig IV CSP and 5,840 lbs. bulk Muscle Pig III CSP
DISTRIBUTION
MO
___________________________________
PRODUCT
Muscle Pig IV CSP Medicated, A Complete Starter Feed for Baby Pigs,
    labeled as containing 100 g/ton chlortetracycline, 0.011% sulfathiazole,
    and 50 g/ton penicillin (as procaine), packaged in 50-lb. bags, 7-day
    withdrawal period. Recall # V-039-2007;
b) Muscle Pig III CSP Medicated, A Complete Starter Feed for Baby Pigs,
    labeled as containing 100 g/ton chlortetracycline, 0.011% sulfathiazole,
    and 50 g/ton penicillin (as procaine), packaged in 50-lb. bags 7-day
    withdrawal period. Recall # V-040-2007
CODE
a) Requisition (batch) 0604 and 14143;
b) Requisition (batch) 15337
RECALLING FIRM/MANUFACTURER
Recalling Firm: MFA Inc, Columbia, MO, by telephone on April 10, 2007 and April 11, 2007.
Manufacturer: MFA Inc, Gerald, MO.  Firm initiated recall is complete.
REASON
The product was supposed to only contain AureoZol containing sulfathiazole, but Aureomix containing sulfamethazine was also used.
VOLUME OF PRODUCT IN COMMERCE
229/50-lb. bags Muscle Pig IV and 60/50-lb. bags Muscle Pig III
DISTRIBUTION
MO
___________________________________
PRODUCT
a) Muscle Pig III CSP Medicated, A Complete Starter Feed for Baby Pigs,
    labeled as containing 100 g/ton chlortetracycline, 0.011% sulfathiazole,
    and 50 g/ton penicillin (as procaine), sold in bulk and in 50-lb. bags,
    7-day withdrawal period, Recall # V-041-2007;
b) Muscle Pig IV CSP Medicated, A Complete Starter Feed for Baby Pigs,
    labeled as containing 100 g/ton chlortetracycline, 0.011% sulfathiazole,
    and 50 g/ton penicillin (as procaine), packaged in 50-lb. bags, 7-day
    withdrawal period. Recall # V-042-2007
CODE
a) Requisition (batch) 14288, 14546, 15055 (bulk feed only), and 15115;
b) Requisition (batch) 14485, 14717, 14793, and 15193
RECALLING FIRM/MANUFACTURER
Recalling Firm: MFA Inc, Columbia, MO, by telephone on April 11, 2007.
Manufacturer: MFA Inc, Gerald, MO.  Firm initiated recall is complete.
REASON
The product is mislabeled as containing sulfathiazole, but it actually contains sulfamethazine.
VOLUME OF PRODUCT IN COMMERCE
3,900 lbs. bulk and 235/50-lb. bags Muscle Pig III, and 350/50-lb. bags Muscle Pig IV
DISTRIBUTION
MO

END OF ENFORCEMENT REPORT FOR MAY 16, 2007

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