Bayer, CSL Behring Recall Antihemophilic Factor Products Formulated with Sucrose
The potency of the active ingredient in several lots of Kogenate FS and Helixate FS antihemophilic factor when analyzed during stability testing has been declining faster than expected, prompting Bayer HealthCare LLC and CSL Behring LLC to extend recalls the companies said they initially communicated a month ago, according to notices posted on Monday by FDA.
Both products are manufactured by Bayer. Their active ingredient is coagulation factor VIII produced by recombinant DNA technology and stabilized in part by sucrose.
The recalls affect Kogenate FS and Helixate FS lots made with active ingredient manufactured before November 2015.
Two of these lots — Kogenate FS 2000 IU lot 270PWG8 and Kogenate FS 3000 IU lot 270NPV2 — were distributed between May 19, 2014, and February 23, 2015. Bayer said the potency of antihemophilic factor in those lots' vials during stability testing decreased below the product's acceptable range of coagulation factor VIII activity.
The potency of antihemophilic factor in two other lots — Helixate FS 2000 IU lot 270PWG6 and Helixate FS 1000 IU lot 270NV9G — also decreased below the acceptable range during stability testing. CSL Behring did not state when vials in those lots were distributed.
Bayer and CSL Behring said antihemophilic factor potency "may eventually fall below the pre-specified acceptable range before shelf life expiry" for the following lots:
- Kogenate FS 250 IU lots 270RV8X and 270TN10,
- Helixate FS 250 IU, lots 270P892, 270PH46, 270P4NL, 270R5CH, 270R0LV, 270R7N5, 270RV8T, and 270TGX1
- Kogenate FS 500 IU lots 270R70V, 270RJ5L, 270T306, and 270TG7L,
- Helixate FS 500 lots 270NTPP, 270P8V6, 270R5K1, 270RR6J, 270RHG3, 270RTPX, and 270T2T8,
- Kogenate FS 1000 IU lot 270TWOR,
- Helixate FS 1000 IU lots 270P9CR, 270RV9C, 270T0R4, 270T508, 270TW0V, and 270V5P1,
- Helixate FS 2000 IU lots 270NW81, 270PCPX, 270PP8N, 270R0NN, 270R53J, 270R9HV, 270RR1G, and 270T556,
- Kogenate FS 3000 IU lot 270TTR6, and
- Helixate FS 3000 IU lots 270NPV1, 270NT1J, 270PJ1G, 270PP5C, 270R83W, 270RXCT, 270T4G4, 270TG53, 270TGWJA, 270TGWJ, and 270TTR7.
The companies said customers should "quarantine inventory of the affected product under their direct control" and contact pharmacies to have them return any affected product in their inventories.
The recalls that the companies said they communicated on July 21 concerned the following lots:
- Kogenate FS 2000 IU lots 270R978 and 270TN1C, and
- Helixate FS 2000 IU lots 270R979 and 270TN1G.