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January 5, 2000

Acetaminophen Tablets Extra Strength Recalled

Allegan, MI (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Perrigo Company of Allegan, MI, is recalling Acetaminophen Tablets Extra Strength, 500 mg, bottles of 100 distributed under numerous brand names and distributors are listed below, because of tablet discoloration due to mold (penicillin species).

According to FDA - 44,736 bottles of 100 were distributed nationwide.

Product codes as follows:
Acetaminophen Tablets Extra Strength, 500 mg, bottles of 100, OTC pain reliever under the following brand names:

a) ARBOR brand NON-ASPIRIN PAIN RELIEF EXTRA STRENGTH. Distributed by Arbor Drugs, Inc., Troy, Michigan. NDC 50165-405-78.
b) Chateau brand EXTRA STRENGTH Non-Aspirin Tablets, Distributed by Preferred Products, Inc., Eden Prairie, MN. [label bears no NDC#].
c) Drug Guild brand EXTRA STRENGTH NON-ASPIRIN PAIN RELIEF, Distributed by Drug Guild Distributors, Inc., Secaucus, New Jersey. [label bears no NDC#].
d) Equate brand extra strength NON-ASPIRIN PAIN & FEVER RELIEF. Manufactured by Perrigo Co., Allegan, MI. [Label bears no NDC#].
e) FOOD LION brand Extra Strength PAIN RELIEVER, Distributed by Food Lion, Inc., Salisbury, NC 28144. [Label bears no NDC#].
f) GOOD SENSE brand EXTRA STRENGTH NON-ASPIRIN PAIN RELIEVER, Perrigo, Allegan, MI. [Label bears no NDC#]
g) Kroger brand EXTRA STRENGTH Pain Reliever Acetaminophen, 500 mg, Distributed by The Kroger Co., Cincinnati, Ohio. [label bears no NDC#].
h) Marquee brand EXTRA STRENGTH Non-Aspirin Pain Reliever-Fever Reducer Acetaminophen, 500 mg, Distributed by Fleming Companies, Inc., Oklahoma City, OK 73216. NDC 11205-405-78.
i) NEX brand EXTRA STRENGTH Pain Reliever Acetaminophen, 500 mg, Distributed by Nexcom, Virginia Beach, Virginia. [label bears no NDC#].
j) Shurfine brand EXTRA STRENGTH Non-Aspirin, 500 mg Distributed by Shurfine International, Inc., Northlake, IL 60164-1889. [label bears no NDC#].
k) spartan brand extra strength pain reliever without aspirin Acetaminophen - Strong Pain & Fever Relief, 500 mg, Distributed by Spartan Stores, Inc., Grand Rapids, Michigan. NDC 11213-405-78.
l) STOP & SHOP brand PAIN RELIEF, 500 mg, Distributed by Stop & Shop Supermarket Co., Boston, Massachusetts. [label bears no NDC#].
m) TOP CARE brand EXTRA STRENGTH ASPIRIN FREE Pain Relief, 500 mg., Distributed by Topco Associates, Inc., Skokie, Illinois NDC 36800-405-78

This ongoing Class II recall was initiated by the company by letter dated November 19, 1999.  This is the first public notice issued by the FDA.

Recall #D-187-0. CODE Lot #8EC037.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

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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