FOOD AND DRUG
ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
February 25, 1998PRODUCT
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. |
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