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October 2009


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"Geis, Phil" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Wed, 14 Oct 2009 22:18:35 -0400
text/plain (77 lines)
Recall - Health Canada recall was based only on failed USP PET - no
contamination reported in market.  Deleted manuf/product name, you can
find these at following if interested:

Oct 14---<snip> recalls <snip> Solutions---Canada 
Manufacturer: See Below
Product: Medical
Start Date: 2009-10-14  End Date: 2009-11-14

Trade Name - <snip> 

Recalling Firm  - 

Hazard Classification - Type III 

Dosage Form - Solution 

Strength - 50 & 450 mL 

Reason for Recall 
The reason for the recall is that based on the preservative challenge
test there was significant growth of yeast and mold when the product was
exposed. However, the recalled lots were tested for Microbial
contamination and found to be well within USP limits. The recall is
based solely on the preservative challenge test. 

Depth of Recall - Distribution 
Two Wholesalers and 1 Pharmacy. No exports.

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