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Recall Observatory FDA recall evidence

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

December 28, 2016

Class II

Product summary

Firm
L. Perrigo Company
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

    reason.microbial_contamination · v1.0.0

    Microbial Contamination