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 Plainfeld, NJ 07080.
This recall has been terminated (originally issued April 12, 2017).
- Company
- G & W Laboratories Inc
- Recall Initiated
- March 20, 2017
- Posted
- April 12, 2017
- Recall Number
- D-0636-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 230,700 tubes
- Firm Location
- South Plainfield, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Distribution
Nationwide in the USA and Puerto Rico
Lot / Code Info
Lot #: a) 63800090, Exp 04/17; 63800095, Exp 11/17; 1000573, Exp 02/18; 1002560, Exp 06/18; b) 63800090, Exp 04/17; 63800092, Exp 07/17; 63800093, Exp 08/17; 63800095, Exp 11/17; 1000574, Exp 02/18; 1001772, Exp 05/18; c) 63800089, Exp 03/17; 63800091, Exp 07/17; 63800094, Exp 08/17; 1000842, Exp 01/18; 1000966, Exp 03/18; 1001771, Exp 05/18; 1002562, Exp 06/18.
More recalls by G & W Laboratories Inc
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (ND...
Feb 14, 2018 · Class III
G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tub...
Jul 12, 2017 · Class III
Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-09...
Mar 22, 2017 · Class III
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