Ciclopirox Olamine Cream USP, 0.77% recall — FDA D-0250-2018
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Overview of recall records associated with G & W Laboratories, Inc., including dates, categories and classifications where available.
Classification mix: Class III: 5, Class II: 1.
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation…
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Failed Content Uniformity Specifications; at the 18 month time point.
This page summarizes recall records in which the official source identifies G & W Laboratories, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.