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FORM 8-K
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
January 30, 1998
ROBERTS PHARMACEUTICAL CORPORATION
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(exact name of registrant as specified in its charter)
New Jersey 1-1-432 22-2429994
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(State or other (Commission (IRS Employer
jurisdiction of File Number Identification
incorporation) Number)
Meridian Center II
4 Industrial Way West
Eatontown, New Jersey 07724
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(Address of principal executive offices, including zip code)
Registrant's telephone number, including area code: 732-389-1182
Meridian Center II
4 Industrial Way West
Eatontown, New Jersey 07724
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(Former name or former address, if changed from last report)
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Item 5. Other Events
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Roberts Pharmaceutical Corporation announced today that it is voluntarily
recalling its 4-ounce size antitussive, decongestant and expectorant product
ENTUSS-D Jr. Pediatric Expectorant, due to a labeling error in the adult dosage
instructions. Only 538 bottles of a single lot of product is involved, Lot
J960855A. This labeling error represents a major potential risk to health due to
the potential for overdose, which may result in serious adverse health
consequences.
Although the Company has not received a single patient/pharmacist complaint
subsequent to usage since the lot was released in January 1997, Roberts is
recalling the lot to safeguard the public.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
ROBERTS PHARMACEUTICAL CORPORATION
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(Registrant)
Date: February 5, 1998 /s/ Anthony A. Rascio
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Anthony A. Rascio
Vice President
