| Reason for the Action |
Medsurge has been made aware that there is strong evidence to suggest vials from batch number BN: 0286, have potentially been either counterfeited (falsified), OR subjected to significant manufacturing anomalies OR both, in which case reliable lab testing has shown:
1. The “suspect” vials will not contain any active ingredient;
2. They may or may not contain a visible black precipitate;
3. There is a possibility of microbial (mould) contamination; and
4. The primary packaging between unaffected and “suspect” vials has several subtle differences that in totality, could be used as an identification tool.
As there is no evidence to suggest otherwise, ALL BATCHES are subject to this notice as a precautionary measure, however, at this time only BN 0286 has been confirmed to be affected via lab testing and as a result, only this batch is being recalled in its entirety. |