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October 1, 2003

Monserrat Pharmaceuticals Has Recalled Albuterol Sulfate

(SafetyAlerts) - The FDA has released the following information.

PRODUCT
Albuterol Sulfate 0.083%, unit-dose vial containing
Albuterol Sulfate Inhalation Solution, Rx ONLY, Pre-mix
solution for inhalation only, Distributed and
manufactured by Farmacia (Pharmacy) La Monserrate, Calle
Munoz Rivera, Esq. Monserrate, Aguas Buenas, PR. The
units are packaged in white cardboard boxes containing
the vials needed by the patient for the month. The box
has a custom made, typewritten pharmacy label. At the
other side of the box, there is another label with the
lot # and expiration date. Recall # D-335-3;
b) Ipratropium Bromide 0.02%, unit-dose vial, pre-mixed
solution for inhalation only, Rx Only. The units are
packaged in white cardboard boxes containing the vials
needed by the patient for the month. The box has a
custom made, typewritten pharmacy label in one side. At
the other side of the box, there is another label with
the lot# and expiration date. Recall # D-336-3

CODE
a) All codes manufactured and distributed between June and
July 2003.
b) All codes manufactured and distributed between April and
July 2003.

RECALLING FIRM/MANUFACTURER
Monserrat Pharmaceuticals, Inc., Aguas Buenas, PR, by visit starting on July 20, 2003. Firm initiated recall is ongoing.

REASON
Good Manufacturing Practice deviations; including, but not limited to, lack of testing for approval or release, stability data, and validation for cleaning/manufacturing operations.

VOLUME OF PRODUCT IN COMMERCE
44,000.

DISTRIBUTION
Puerto Rico.

 
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Health Professional:

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During 2000 there were over
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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.