September 20, 2000Packaging Problems Prompt Wyeth
to Recall Three Products
PA (SafetyAlerts) - The Food and
Drug Administration (FDA) has announced that Wyeth Ayerst Laboratories is recalling
certain lots of its Digoxin Injection, Dimenhydrinate Injection, and its Diphenhydramine
HCl Injection in Tubex cartridge packaging because the Tubex(r) cartridges may be cracked
This is the first public notice of
this Class II
recall issued by FDA.
a) Digoxin Injection USP 0.25 mg per ml, 1 ml Tubex cartridge, 10 cartridges per
package; 60 cartridges per case, is used to treat heart failure, atrial fibrillation and
atrial flutter. NDC #0008-0480-02.
b) Dimenhydrinate Injection USP 50 mg per ml, 1 ml Tubex cartridge, 10
cartridges per package; 60 cartridges per case. The product is used to prevent and treat
nausea, vomiting, or vertigo related to motion sickness. NDC #0008-0485-01.
c) Diphenhydramine HCl Injection USP 50 mg per ml, 1 ml Tubex cartridge,
10 cartridges per package; 60 cartridges per case. The product is used to treat motion
sickness and is consider an antihistamine and antiparkinson drug. NDC
a) 4990194 exp. 5/01
b) 49990197 exp. 10/01
c) Lot 49990052 exp. 2/02.
Wyeth Ayerst Laboratories, Marietta, Pennsylvania.
Manufacturer, by letter on July 17, 2000. Firm-initiated recall ongoing.
Nationwide and Puerto Rico.
a) 40,470 tubexes
b) 70,370 tubexes
c) 40,900 tubexes were distributed.
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