Drug 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
D-0434-2017
Product summary
- Event
- Event 76061
- Status
- Terminated
- Classification
- Class II
- Quantity
- 162,534 tubes
- Official record key
drug-enforcement:D-0434-2017
Official wording
Reason: Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Code information: 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)
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination