Is 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 expirat recalled?

Question

Is 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 expirat recalled?

Accepted Answer

Good Manufacturing Practice deviations; including, but not limited to, lack of testing for approval or release, stability data, and validation for cleaning/manufacturing operations.  The firm is also not registered as drug manufacturer.

Distribution: Product distributed to patients in Puerto Rico only.

Monserrat Pharmaceuticals Inc.: Good Manufacturing Practice deviations; including, but not limited to, lack of testing for approval or release, stability data, and validation for cleaning/manufacturing operations. The firm is also not registered as drug manufacturer.

Additional Information

Were You Affected by This Recall?

Monserrat Pharmaceuticals Inc.: Good Manufacturing Practice deviations; including, but not limited to, lack of testing for approval or release, stability data, and validation for cleaning/manufacturing operations. The firm is also not registered as drug manufacturer.

Additional Information

Were You Affected by This Recall?