G&w Laboratories

6 FDA enforcement records linked to this company.

• recall — Class III2018-02-14

  Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.

• recall — Class III2017-07-12

  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 product.

• recall — Class III2017-04-12

  Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.

• recall — Class III2017-03-22

  CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.

• recall — Class II2017-03-08

  Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.

• recall — Class III2014-01-08

  Failed Content Uniformity Specifications; at the 18 month time point.