Recalls / Class II
Class IID-0434-2017
Product
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed by Perrigo, Allegan, MI --- NDC 45802-736-84, UPC 345802736840
- Brand name
- Clindamycin Phosphate And Benzoyl Peroxide
- Generic name
- Clindamycin, Benzoyl Peroxide
- Active ingredients
- Benzoyl Peroxide, Clindamycin Phosphate
- Route
- Topical
- NDC
- 45802-736
- FDA application
- ANDA090979
- Affected lot / code info
- 080806 (exp 12/16) 080844 ( exp 12/16) 080963 (exp 12/16) 080999 ( exp 12/16) 0841 09 ( exp 03/17 084197 ( exp 03/17) 091 090 ( exp 1 0/17) 092319 (exp 11/17) 092399 ( exp 12/17) 092440 ( exp 12/17)
Why it was recalled
Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Recalling firm
- Firm
- L. Perrigo Company
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 162,534 tubes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-12-28
- FDA classified
- 2017-01-17
- Posted by FDA
- 2017-01-25
- Terminated
- 2017-08-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0434-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.