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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
January 13, 1999

PRODUCT
Various Rx drugs:
a) Metoprolol Tartrate Injection, 5 mg/5ml, in 5 ml single dose
vials, NDC #0364-3036-25 (Schein); b) Hydrocortisone Acetate
Injectable Suspension, USP, 25 mg/ml, in 10 ml multiple dose
vials, NDC #0402-0051-10 (Steris), NDC 0364-6624-54 (Schein);
c) Dexamethasone Acetate Injectable Suspension, USP, 8 mg/ml, in
5 ml multiple dose vials, NDC 0402-0092-05 (Steris)
NDC 0364-6699-53 (Schein)
NDC 0588-5344-75 (Keene)
NDC 0456-1075-05 (Forest)
NDC 0182-0928-62 (Goldline)
NDC 52384-068-05 (Teregen Labs)
NDC 63252-7644-3 (Radford Therapeutics);
d) Pentamidine Isethionate for Injection, lyophilized, 300 mg, in
single dose vials, NDC 0209-8560-20 (Marsam);
e) Methylprednisolone Acetate Injectable Suspension, USP, 40
mg/ml, in 10 ml multiple dose vials, NDC 0402-1069-10 (Steris)
NDC 0364-3064-54 (Schein)
NDC 57699-069-10 (A & G Pharmaceutical)
63252-1111-1 (Radford Therapeutics);
f) Methylprednisolone Acetate Injectable Suspension, USP, 80
mg/ml, in 5 ml multiple dose vials, NDC 0402-1070-05 (Steris)
NDC 0364-3065-53 (Schein)
NDC 55553-070-05 (Clint Pharmaceuticals)
NDC 63252-1112-5 (Radford Therapeutics)
NDC 0677-1539-20 (United Research Laboratories);
g) Estrone Injectable Suspension, USP, 5 mg/ml, in 10 ml multiple
dose vials, NDC 0402-0041-10 (Steris)
NDC 0364-6601-54 (Schein)
NDC 57699-041-10 (A&G Pharmaceutical)
NDC 0677-0274-21 (United Research Laboratories);
h) Testosterone Injectable Suspension, USP, 100 mg/ml, in 30 ml
multiple dose vials, NDC 0402-0084-30 (Steris)
DIN 00616931 (Univet Pharmaceuticals);
I) Triamcinolone Diacetate Injectable Suspension, USP, 40 mg/ml,
in 5 ml multiple dose vials, NDC 0402-1071-05 (Steris)
NDC 0364-3081-53 (Schein)
NDC 0677-0981-20 (United Research Laboratories)
NDC 0182-3064-62 (Goldline)
NDC 0456-1060-05 (Forest)
NDC 11001-071-05 (San Jose Surgical Supply);
j) Vercuronium Bromide for Injection, Lyophilized Powder, 10 mg,
in 10 ml vials, NDC 0209-9140-22 (Marsam)
NDC 0209-9140-92 (Marsam)
NDC 0209-9141-26 (Marsam);
k) Vecuronium Bromide for Injection, Lyophilized Powder, 20 mg,
in 20 ml vials, NDC 0209-9143-22 (Marsam)
NDC 0209-9143-92 (Marsam).  Recall #D-046/056-9.

CODE
Lot numbers:  a) 98A910, 98B570, 98C250, 98C890;
b) 98A210; c) 98A280, 98A890; d) 98A480; e) 98B300;
f) 98B520, 98B960, 98C790; g) 98B250; h) 98B410;
I) 98B490, 98B940;
j) 98A080, 98A260, 98A450, 98B090, 98B110, 98B330, 98B340,
98B540, 98B750, 98B770, 98C150, 98C270, 98C340, 98C530, 98C700,
98D080, 98D760;
k) 98A170, 98B120, 98B350, 98B780, 98C390, 98D110,
98D770.

MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.

RECALLED BY
Manufacturer, by letter on October 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Puerto Rico, Kenya, Africa, Nova Scotia, Canada.

QUANTITY
a) 231,465 vials; b) 9,044 vials; c) 168,557 vials; d) 6,088 vials; e) 35,934 vials; f) 173,188 vials; g) 3,484 vials; h) 1,925 vials; I) 138,733 vials; j) 674,440 vials; k) 67,730 vials were distributed.

REASON
Possible cross contamination with Triamcinolone Acetate.

 

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.