D-0893-2018 Class III Terminated
FDA drug recall D-0893-2018 was initiated by Qualgen, LLC on June 8, 2018 and is designated Class III. Reason for recall: Labeling: Incorrect or Missing Lot and/or Exp Date. The recall status is terminated (terminated November 25, 2020).
Recall Details
- Product Type
- Drugs
- Report Date
- July 11, 2018
- Initiation Date
- June 8, 2018
- Termination Date
- November 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date.
Distribution Pattern
Nationwide in the USA
Code Information
lot# D001 EXP: 01/02/2018 CPD: 01/02/2019