January 5, 2000Acetaminophen Tablets Extra
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
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.
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