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SafetyAlerts
September 20, 2000

Packaging Problems Prompt Wyeth to Recall Three Products

Marietta, 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 or chipped.

This is the first public notice of this Class II recall issued by FDA.

PRODUCT
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 #0008-0384-01.

Recall #D-453/455-0.

CODE
Lot Numbers:

a) 4990194 exp. 5/01
b) 49990197 exp. 10/01
c) Lot 49990052 exp. 2/02.

MANUFACTURER
Wyeth Ayerst Laboratories, Marietta, Pennsylvania.

RECALLED BY
Manufacturer, by letter on July 17, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY
a) 40,470 tubexes

b) 70,370 tubexes
c) 40,900 tubexes were distributed.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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