Medicine Recalls and Alerts 2002 (TXT)

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Monday, April 01, 2002 10:49 PM

Medicine Recalls and Alerts 2002 (TXT)

 

 

> eMedicine Recalls and Alerts 2002-

> http://www.emedicine.com/recalls_and_alerts.htm#AAMedical -

>

> Recalls and Alerts 2002

> Go to the site for past Recalls and Alerts.

>

> 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.

>

>

> 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.

>

>

> 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 Lyme Vaccine Withdrawn from Market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.

>

>

> 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.

>

>

>

> 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.

>

>

> 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.

>

>

> 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

>

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