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Recall Observatory FDA recall evidence

Drug product

Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080.

D-0250-2018

January 19, 2018

Class III

Product summary

Firm
G & W Laboratories, Inc.
Event
Event 78974
Status
Terminated
Classification
Class III
Quantity
142,236 tubes
Official record key
drug-enforcement:D-0250-2018

Official wording

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

Code information: Lot #: a) 1002896, Exp 09/18; 1005797, Exp 05/19; 1006100, Exp 07/19; b) 1002561, Exp 06/18; 1002897, Exp 09/18; 1005798, Exp 05/19; 1006101, Exp 07/19; c) 1002898, Exp 10/18; 1004283, Exp 12/18; 1005837, Exp 05/19; 1006321, 1006322, Exp 07/19

Distribution pattern: Nationwide in the USA and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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