MEDICINE RECALL - UPDATE
CHLOROFLUOR GEL 30ml, 250ml, 100ml PUMP
Product number: 35530, 35532, 35533
Batch numbers: BK 119
AUST R 21505
TGA Ref: RC-2016-RN-00880-
Dear Dealer Partner,
Further to the letter dated July 1st concerning the recall and quarantine of the Chlorofluor GEL Batch BK 119. We are pleased to advise that batches BL033 (current batch) and BK099 comply with the release requirements of TG077 Clause 9(1). Extensive testing from multiple test laboratories, including the TGA, have found no bacterial contamination detected in these batches. This result enables the immediate release of ALL sponsor quarantined stock of batches BL033 and BK099.
Any and all backorders will also be released without delay from PDS. In closing this recall, all batch BK119 identified product will be replaced in full.
Without delay, kindly notify the relevant department within your business to initiate the immediate return of batch BK119 from your facilities to PDS where it will be destroyed.
Additional testing regimes have been established to ensure future batches exceed the nominated testing criteria. Further to this letter please find attached a copy of each of the Laboratory reports for your review. PDS sincerely thanks you for your patience in dealing with this matter. We do acknowledge that this has caused inconvenience to your business and apologise. For the past 27 years PDS has established a product credibility and confidence in its range and we wish to reaffirm our commitment to this quality along with our manufacturing partners.
We thank you for your continued support of our business.
Sinikka Knight, Director
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