Medicine & Vaccine Recalls and Alerts 2002

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eMedicine Recalls and Alerts 2002

 

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Recalls and Alerts 2002

Click here for past Recalls and Alerts.

3/19/02

FDA Recalls All Medical Devices from A & A Medical, Inc

The FDA has issued a recall of all medical devices manufactured by A & A

Medical, Inc. of Alpharetta, GA, labeled as sterile and shipped since 1999

nationwide. A & A Medical also does business as A & A Medical/Rocket USA, and

Lifequest. The devices may not have undergone sterilization. A & A Medical

manufactures many types of obstetrics, gynecology, and surgical devices. The

recall includes, but is not limited to curettes (flexible and rigid), uterine

dilators, fetal blood samplers, and laparoscopy accessories. Please refer to the

link below for a current list of known products affected by this recall.

 

Find more information at FDA Safety Alert.

 

 

3/1/02

Midazolam (Versed) Syrup Recalled

Roche pharmaceutical has issued a class I recall for midazolam (Versed)

oral syrup. The recall affects the 118 mL bottle (2 mg/mL) of lots U0009-50 and

U0010-50. The recall is due to the potential crystalline precipitate of an

insoluble complex of midazolam and saccharin. If present, this precipitate

causes the syrup to lack uniformity; thus, it may result in the administration

of a super or subpotent dose.

 

Find more information at FDA MedWatch.

 

 

2/26/02

Lyme Vaccine Withdrawn from Market

A decrease in demand of lyme vaccine (LYMErix) resulting in poor sales has

prompted Glaxo SmithKline to withdraw it from the market. The company's decision

was announced despite federal health officials warning that Lyme disease cases

had reached record highs in recent years.

 

Find more information at News.

 

 

2/20/02

Pentothal Ready-To-Mix Syringe 500 mg 2.5% (25 mg/mL)

The voluntary recall by Abbott Hospital Products Division is due to a

single 400 mg pentothal vial found in a single 500 mg pentothal kit within a

case of 25 kits. The NDC number affected is 0074-6420-01 and the lot number is

80-076-DK. Only the referenced lot number is affected. Institutions who have

pentothal supplies with that referenced lot number are encouraged to contact

Abbott Customer Service (1-800-222-6883) to obtain return information..

 

For more information contact Abbott Hospital Products Division

(1-800-222-6883).

 

 

2/20/02

Clozapine Associated with Fatal Myocarditis

Post-marketing surveillance data of patients taking clozapine in the

United States, Canada, United Kingdom, and Australia show a myocarditis

incidence of 5, 16.3, 43.2, and 96.6 cases/100,000 patient years, respectively.

Fatalities were reported to occur at a rate of 2.8, 2.3, 11.5, and 32.2

cases/100,000 patient years, respectively. The increased risk of fatal

myocarditis is particularly prevalent within the first month of treatment.

 

Individuals taking clozapine who experience unexplained fatigue, dyspnea,

tachypnea, fever, chest pain, palpitations, other signs or symptoms of heart

failure, or electrocardiographic findings such as ST- T wave abnormalities or

arrhythmias should be evaluated for myocarditis.

 

Find more information at FDA MedWatch.

 

 

2/08/02

CDC Updates Childhood Immunization Schedule

New recommendations include an annual influenza vaccine for children with

risk factors (eg, cardiac or sickle cell disease, diabetes mellitus, HIV), which

may increase the likelihood of influenza complications. Also emphasized is

vaccine coverage for adolescents who have missed vaccine doses. Administering

missed doses of hepatitis B vaccine for age 11-12 years was expanded to include

the entire " preadolescent " period (ie, 2-18 years). Those 14-18 years old are

now part of the age groups that should be brought up-to-date on MMR. The

catch-up ages for varicella vaccination were expanded to include children up to

age 18 years. The new guidelines also mention that administering a dose up to 4

days earlier than the minimum interval of age is unlikely to have a significant

negative impact on the immune response to that dose. In addition, aspiration

prior to injecting a dose IM, is no longer recommended in the " 2002 General

Recommendations on Immunization " because no data exist to document the necessity

of this procedure. All preterm infants born to mothers that are HbsAg positive

or whose HbsAG status is unknown should be given hepatitis B vaccine and HBIG

within 12 h of birth and receive additional doses at 1, 2, and 6 months. The

birth dose of hepatitis B should not be counted. MMWR 2002;51(No. RR-2):1-34

 

Find more information at Centers for Disease Control.

 

 

1/15/02

Oseltamivir (Tamiflu) suspension unavailable this flu season

Roche Laboratories Inc. has announced a production problem at a

manufacturing site in Switzerland will prevent distribution of Tamiflu powder

for suspension during the current flu season in the United States. The

production problem does not affect distribution of the capsules, which may be

used in children >40 kg, adolescents, and adults.

 

Find more information at Finance.

 

 

1/9/02

Liver failure warnings and nefazodone (Serzone)

Rare cases of liver failure leading to transplant and/or death in patients

have been reported. The package insert now includes a Black Box Warning

explaining the observation of an observed rate in the United States is about 1

case of liver failure resulting in death or transplant per 250,000 - 300,000

patient-years on postmarketing experience in more than 7.2 million patients in

the United States.

 

Find more information at FDA MedWatch.

 

 

1/4/02

CDC Advises Deferring DTaP Vaccine in Older Children

In an effort to reserve enough diphtheria, tetanus toxoids, and acellular

pertussis adsorbed vaccine (DTaP) for young infants, the CDC's Advisory

Committee on Immunization Practices (ACIP) has asked health care providers to

defer administering doses of the vaccine to older children. Health care

providers who lack sufficient DTaP stocks and cannot maintain all of their young

patients on the five-dose childhood immunization schedule should defer the

fourth DTaP dose.

 

If deferring the fourth dose (usually given at age 15-18 mo) does not free

up enough DTaP for infants to receive their first 3 doses on schedule, ACIP

recommends deferring the fifth dose (administered between age 4-5 y).

 

In areas where the shortage of DTaP is " severe, " ACIP said local public

health authorities could recommend community wide deferral of the fourth dose

and possibly the fifth. MMWR 2002; 50(51):1159

 

Find more information at Centers for Disease Control and Prevention.

 

 

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