Class III
Terminated
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.
This recall has been terminated (originally issued February 14, 2018).
- Company
- G & W Laboratories Inc
- Recall Initiated
- January 19, 2018
- Posted
- February 14, 2018
- Recall Number
- D-0250-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 142,236 tubes
- Firm Location
- South Plainfield, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Distribution
Nationwide in the USA and Puerto Rico
Lot / Code Info
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
More recalls by G & W Laboratories Inc
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Apr 12, 2017 · Class III
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