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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
February 25, 1998

PRODUCT
Entuss-D Jr (Hydrocodone Bitartrate 2.5
mg/Pseudoephedrine Hydrochloride 30 mg),
Pediatric Expectorant Antitussive and Nasal
Decongestant, Rx, in 4 fluid ounce bottles.
NDC #59441-439-04.

Recall #D-078-8.

CODE

Lot #J960855A EXP 10/98
.
MANUFACTURER

Mikart, Inc., Atlanta, Georgia (contract
manufacturer).

RECALLED BY

Roberts Pharmaceutical Corporation, Eatontown,
New Jersey (responsible firm), by press
release on January 30, 1998, followed by
letter. Firm-initiated recall ongoing.

DISTRIBUTION

Eastern United States.

QUANTITY

538 bottles were distributed.

REASON

Misbranding - Incorrect label dosage
instructions for adults which may lead to an
overdose situation.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.