Talecris has issued a recall for HyperRHO™ S/D, Rh0 (D) Immune Globulin (Human) (Mini-Dose) lot number 26N7XX1.
Talecris distributed the recalled lot only to customers in the United States.
Please find the details regarding this recall within the attached document below.
Recall Notice: HyperRHO™ S/D Mini-Dose
Compare Rh0(D) Immune Globulin (Human) Products (PDF)
The products discussed herein may only be dispensed with a prescription from a doctor or healthcare provider.
For Prevention of Rh Hemolytic Disease of the Newborn (HDN)
Each year approximately 540,000 pregnancies in the US are complicated by maternal-fetal Rh0 (D) blood type incompatibility. Although the risk to the first fetus is only slight, subsequent pregnancies carry progressively higher risk of life-threatening hemolytic disease of the fetus. Treatment with HyperRHO™ S/D, Rh0(D) Immune Globulin (Human), can reduce the risk of hemolytic disease for present and future maternal-fetal Rh0(D) incompatible situations.
Recommended Use of HyperRHO™ S/D
Indicated for the prevention of Rh hemolytic disease of the newborn by its administration to the Rh0(D) negative mother within 72 hours after birth of an Rh0(D) positive infant when the following criteria are met:
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The mother must be Rh0(D) negative and must not be already sensitized to the Rh0(D) factor
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Her child must be Rh0(D) positive and should have a negative direct antiglobulin test |
Not for neonatal administration.
For Intramuscular Administration Only
Needle guard can protect against post-injection needlesticks
Available on selected Hypermunes™ products.
Product Attributes
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Solvent/Detergent treatment for virus removal/inactivation (See : Full Dose, Mini-Dose (PDF)
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Pre-filled syringes for single-use IM injection only
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Tamper-evident packaging
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Distinct dosing for women who are postpartum and those who miscarry before 13 weeks gestation |
Contraindications, side effects, and precautions
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Use caution in persons with a history of prior systemic allergic reaction to human immune globulin products or a history of IgA deficiency
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Administration of live virus vaccines (eg, MMR) should be deferred for approximately 3 months after Rh0(D) immune globulin (human) administration
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The most common side effects reported are slight soreness at the site of injection and slight temperature elevation |
Rh0(D) Blood Type Incompatibility Info
Hemolytic Disease of the Newborn (HDN)
HDN, also known as erythroblastosis fetalis or "blue baby syndrome," occurs when a pregnant woman's Rh blood type differs from her baby's. Rh refers to the presence or absences of the Rh antigen; blood is considered either Rh positive or Rh negative.
Rh incompatibility causes the woman's antibodies to attack and destroy the baby's red blood cells. In response to the attack on its red blood cells, the baby reacts by manufacturing a large number of red blood cells quickly. The baby's liver is unable to handle the increased work, and fluid begins to collect throughout the baby's body.
After delivery, the baby might experience severe newborn jaundice (yellowing of the body and skin) and a low red blood cell count (anemia).
Intravenous immune globulin can be used to treat an Rh-negative mother who gives birth to an Rh-positive infant.
HyperRHO S/D Full Dose — Important Safety Information
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NEVER ADMINISTER HyperRHO S/D FULL DOES INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. NEVER ADMINISTER TO THE NEONATE.
| HyperRHO S/D Mini Dose — Important Safety Information
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NEVER ADMINISTER HyperRHO S/D MINI DOES INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. ADMINISTER ONLY TO WOMEN POSTABORTION OR POSTMISCARRIAGE BEFORE 13 WEEKS GESTATION. NEVER ADMINISTER TO THE NEONATE.
| As with all plasma-directed therapeutics, the potential to transmit infectious agents, such as viruses, cannot be totally eliminated.
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