Field Correction
Component Pack packaged with Mononine (Coagulation Factor IX, Human)
DATE NOTIFICATION INITIATED:
November 20, 2008
PRODUCT / LOT NUMBER / EXPIRATION DATE:
| Mononine Lot Number |
NDC Number | Component Pack Lot Number |
Mononine Expiration Date |
|---|---|---|---|
| J22306 | 0053-7668-04 | 60970417 | 6/19/2010 |
| J22506 | 0053-7668-04 | 60970417 | 6/29/2010 |
| J22607 | 0053-7668-04 | 60970417 | 7/09/2010 |
| J22707 | 0053-7668-04 | 60970417 | 7/14/2010 |
| J23208 | 0053-7668-04 | 60970417 | 8/15/2010 |
MANUFACTURER:
CSL Behring
Kankakee, IL
REASON:
CSL Behring has identified an incidence of component packs that did not have a complete seal between the soft blister pack and the package cover. Mononine vials are not affected, only the component packs. To determine if your inventory is effected, match both the product lot number and the component pack lot number. The combination of the two lot numbers must match to be effected by this field correction. CSL Behring will ship sufficient replacement component packs to direct customers.
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.