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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
February 4, 1998

PRODUCT
Caffeine and Sod

PRODUCT
Caffeine and Sodium Benzoate Injection, USP,
0.5 g/2 ml, Rx sterile solution for
intramuscular or slow intravenous
administration to treat respiratory depression
associated with overdosage with CNS depressant
drugs. NDC #11098-505-02.

Recall #D-057-8.

CODE

Lot #101406.

MANUFACTURER

Taylor Pharmaceuticals, Decatur, Illinois.

RECALLED BY

Manufacturer, by letter dated November 25,
1997. Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide and Canada.

QUANTITY

366 cartons were distributed; firm estimated
that 33 percent of product remained on market
at time of recall initiation.

REASON

Mislabeling - The ampule label and shelf
carton fail to list the strength of the
caffeine and sodium benzoate. Also, the shelf
carton lists the ampule size as 2 ml on the
principle display panel and 1 ml the end flap.

Arabia, Spain, Sweden, Switzerland, United Kingdom.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.