Recalls / Class III
Class IIID-0250-2018
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.
- 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) 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
Why it was recalled
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Recalling firm
- Firm
- G & W Laboratories, Inc.
- Manufacturer
- Cosette Pharmaceuticals, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 200 Helen St, N/A, South Plainfield, New Jersey 07080-3800
Distribution
- Quantity
- 142,236 tubes
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2018-01-19
- FDA classified
- 2018-02-02
- Posted by FDA
- 2018-02-14
- Terminated
- 2020-02-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0250-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.