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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Important Product Information – Evicel and Evithrom

 

DATE NOTIFICATION INITIATED: September 26, 2012
 
 

Evicel® Product Codes
Product Description
 Lot Numbers
S3905
FIBRIN SEALANT (HUMAN) EVICEL* - 5mL Sample
Q02F010
S3905
FIBRIN SEALANT (HUMAN) EVICEL* - 5mL Sample
Q05F120
S3905
FIBRIN SEALANT (HUMAN) EVICEL* - 5mL Sample
Q19F420
S3905
FIBRIN SEALANT (HUMAN) EVICEL* - 5mL Sample
Q35F780
S3905
FIBRIN SEALANT (HUMAN) EVICEL* - 5mL Sample
Q33F700
3901
FIBRIN SEALANT (HUMAN) EVICEL* -1 mL
Q44F97K
3901
FIBRIN SEALANT (HUMAN) EVICEL* -1 mL
Q53F350
3902
FIBRIN SEALANT (HUMAN) EVICEL* -2 mL
Q03F030
3902
FIBRIN SEALANT (HUMAN) EVICEL* -2 mL
Q09F310
3902
FIBRIN SEALANT (HUMAN) EVICEL* -2 mL
Q29F610
3902
FIBRIN SEALANT (HUMAN) EVICEL* -2 mL
Q44F980
3902
FIBRIN SEALANT (HUMAN) EVICEL* -2 mL
Q31F640
3902
FIBRIN SEALANT (HUMAN) EVICEL* -2 mL
Q35F750
3902
FIBRIN SEALANT (HUMAN) EVICEL* -2 mL
Q36F820
3902
FIBRIN SEALANT (HUMAN) EVICEL* -2 mL
Q46F040
3902
FIBRIN SEALANT (HUMAN) EVICEL* -2 mL
Q47F050
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
P44F050
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
P45F100
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
P45F090
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
P46F120
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
P48F180
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R06F130
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R07F180
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R07F190
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R07F250
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R07F260
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R10F310
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R10F320
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R10F330
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R12F380
Evicel® Product Codes
Product Description
 Lot Numbers
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
P48F190
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
P53F390
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q03F040
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
P50F310
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
P50F330
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q02F010
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
P52F370
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q11F320
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
P52F360
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q02F020
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q04F090
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q04F100
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q04F110
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q05F120
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q32F660
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q05F130
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q05F140
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q06F160
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q06F170
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q07F210
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q08F280
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q08F290
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q16F400
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q08F300
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q13F340
Evicel® Product Codes
Product Description
 Lot Numbers
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q33F710
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q13F350
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q14F360
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q14F370
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q15F380
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q15F390
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q19F410
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q28F560
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q19F420
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q21F470
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q21F480
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q32F670
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q31F620
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q31F630
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q22F490
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R03F090
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q28F570
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q35F760
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q29F580
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q29F590
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q33F720
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q34F730
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q34F740
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q32F680
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q33F690
Evicel® Product Codes
Product Description
 Lot Numbers
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q50F210
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q33F700
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q35F770
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q35F790
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q36F810
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q41F900
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R01F010
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R01F020
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R01F030
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q41F920
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q40F880
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q41F910
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q48F090
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R06F140
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q42F940
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q43F950
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q48F100
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q43F960
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q45F990
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q47F070
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q49F140
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q49F150
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q50F220
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q52F300
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R03F080
Evicel® Product Codes
Product Description
 Lot Numbers
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q51F280
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q52F290
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R07F200
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q50F230
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q50F240
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q51F260
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q51F270
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q52F310
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
Q53F330
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R02F060
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R09F270
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R10F300
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R10F340
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R11F350
3905
FIBRIN SEALANT (HUMAN) EVICEL*-5 mL
R12F370
 
 
 
EVITHROM® Product Codes
Product Description
Lot Numbers
S4602
THROMBIN TOPICAL (HUMAN) EVITHROM*- 2mL Sample
Q36T62K
4602
THROMBIN TOPICAL (HUMAN) EVITHROM*- 2mL
P49T05K
4602
THROMBIN TOPICAL (HUMAN) EVITHROM*- 2mL
Q11T44J
4602
THROMBIN TOPICAL (HUMAN) EVITHROM*- 2mL
Q32T46K
4602
THROMBIN TOPICAL (HUMAN) EVITHROM*- 2mL
Q45T77J
4605
THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL
P46T84J
4605
THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL
P50T150
4605
THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL
Q07T23J
4605
THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL
Q08T28K
4605
THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL
Q23T88K
4605
THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL
Q25T93J
4605
THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL
Q25T94J
4605
THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL
Q27T08J
4605
THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL
Q30T31J
4605
THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL
Q31T34J
4605
THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL
Q31T360
4605
THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL
Q32T41K
4605
THROMBIN TOPICAL (HUMAN) EVITHROM* - 5mL
Q33T48J

 
MANUFACTURER:
 
OMRIX biopharmaceuticals, Ltd.
Israel
 
REASON:
 
Ethicon, Inc. is notifying customers of a manufacturing process deviation that may have potentially led to the production of vials of Thrombin with decreased potency. This manufacturing deviation may affect product that was produced before December 25, 2011, and was discovered through an internal review of the manufacturing process. We believe this potential decrease in potency does not pose a risk to patients as the Thrombin level would still be effective in clot formation. Ethicon has not received any reports of adverse events related to this issue. Customers are asked to return product in inventory that corresponds to the lot numbers and code numbers listed.
 
 
______________________________________________________________________________________
 
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.