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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
June 24, 1998

PRODUCT
Schein Pharmaceutical Potassium Chloride for Oral Solution, USP, 20 mEq, Orange Flavor, in 1.5 gram packets of 30 per carton, Rx for therapeutic use in patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis; and for the prevention of potassium depletion. NDC #0364-7378-30. Recall #D-176-8.

CODE
Lot numbers: KC60209-5, KC70203-1, KC60709-1, KC70203-5, KC60710-1, KC70713-4, KC60901-3, KC70819-7, KC60901-4, KC70819-6, KC61122-1, KC71125-6, KC61122-2, KC71125-4.

MANUFACTURER
Bajamar Chemical Company Inc., St. Louis, Missouri (repacker/responsible firm).

RECALLED BY
Repacker, by letter dated April 16, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
New York and Arizona.

QUANTITY
27,024 30-packet cartons were distributed.

REASON
Mislabeling - Exterior cartons incorrectly declare 2.5 grams of potassium chloride.

 

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.