Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
6 FDA recalls mention Calcipotriene. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Calcipotriene.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact…
Reason Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
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