Health Advisory
RECORDING LOT NUMBERS FOR VACCINES
WITH MULTIPLE, LINKED LOT NUMBERS
POSTED: November 12, 2008

Delaware Division of Public Health (DPH) wishes to convey the following information received from the CDC regarding the recording of lot numbers for vaccines with multiple linked lot numbers.

On October 3, 2008, a Notice to Readers was published in the Morbidity and Mortality Weekly Report (MMWR) that said: "Different lot numbers for the different components of Pentacel (DTaP-IPV/Hib) are included on the Pentacel DTaP-IPV vial and on the Hib powder vial and that providers should record lot numbers separately for the DTaP-IPV and Hib components."

Pentacel is supplied as a box containing 5 vials of liquid DTaP/IPV vaccine and 5 vials of lyophilized Hib vaccine. The vaccine component should be kept together in the original box until one vial of each component is removed, reconstituted, and administered. The combined vaccine must be used within 30 minutes of reconstitution.

Pentacel should always be used as a combination vaccine. The liquid DTaP/IPV vaccine should be used only to reconstitute the lyophilized Hib component, and the combined vaccine administered to an individual child. The component vaccines should not be used separately.

The lot numbers of the Pentacel components are linked so that the lot number of one component will identify the lot number of the other component. If Pentacel is used as supplied there is no need to record both numbers - the carton lot number or tear-off lot number label on the hib vial (which are identical) is adequate and identifies all components. However, if the DTaP-IPV component is used to reconstitute a vial of ActHIB that is not supplied as Pentacel, both numbers should be recorded.

Similarly, TriHIBit (DTaP-Hib) has a lot number for each of its two components, and there is no need to record both numbers when used as supplied.

Rotarix rotavirus vaccine (GlaxoSmithKline) is supplied in a carton containing 10 doses of lyophilized vaccine and 10 prefilled oral applicators of diluent. The outer carton, vaccine, and diluent each have different lot numbers which are linked. The lot number from either the outer carton, vaccine or diluent can be used by the manufacturer to identify the other components supplied in the same carton. The outer carton lot number is also listed on the packing slip. Only the outer carton lot number needs to be recorded.

For questions or additional information, please contact DPH's Immunization Program at 1-800-282-8672.

Delaware Health and Social Services is committed to improving the quality of the lives of Delaware's citizens by promoting health and well-being, fostering self-sufficiency, and protecting vulnerable populations.