Recalls / Class III
Class IIID-0636-2017
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 Plainfeld, NJ 07080.
- Brand name
- Ciclopirox Olamine
- Generic name
- Ciclopirox Olamine
- Active ingredient
- Ciclopirox Olamine
- Route
- Topical
- NDC
- 0713-0638
- FDA application
- ANDA078463
- Affected 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.
Why it was recalled
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Recalling firm
- Firm
- G & W Laboratories, Inc.
- Manufacturer
- Cosette Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 111 Coolidge St, N/A, South Plainfield, New Jersey 07080-3895
Distribution
- Quantity
- 230,700 tubes
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2017-03-20
- FDA classified
- 2017-04-04
- Posted by FDA
- 2017-04-12
- Terminated
- 2018-02-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0636-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.