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Recall Enforment Report D-0893-2018

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Qualgen, LLC, originally initiated on 06-08-2018 for the product TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01 The product was recalled due to labeling: incorrect or missing lot and/or exp date.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0893-201806-08-201807-11-2018Class IIITESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01Labeling: Incorrect or Missing Lot and/or Exp Date.Terminated
D-0892-201806-08-201807-11-2018Class III2,940 pelletsESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01Labeling: Incorrect or Missing Lot and/or Exp Date.Terminated