Merck recalls lot of hepatitis B vaccine
Merck Sharp & Dohme Corp. on July 3, 2013 initiated a voluntary recall of 1 lot of its hepatitis B vaccine Recombinant HB Adult Formulation due to potential cracks in the vials.
Merck Sharp & Dohme Corp. on July 3, 2013 initiated a voluntary recall of 1 lot of its hepatitis B vaccine Recombinant HB Adult Formulation due to potential cracks in the vials.
A Merck’s investigation concluded that the potential exists for a crack to have occurred in the vials of lot J001183. The lot was distributed between March 12, 2013 and May 2, 2013. If a vial is cracked, the integrity of the vial and the sterility of any product remaining in the vial cannot be assured.
Merck officials advise that if a product from this lot has already been administered, revaccination is not necessary. Adverse reactions should be reported to FDA’s Vaccine Adverse Event Reporting System.
To get weekly news from the voice of the pharmacist, subscribe to the Drug Topics Community Pharmacists' Report or the Drug Topics Hospital Pharmacists' Report.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
