Home / Recalls / Qualgen, LLC / D-0235-2019

D-0235-2019 Class II Terminated

Recalled by Qualgen, LLC — Edmond, OK

Recall Details

Product Type
Drugs
Report Date
November 14, 2018
Initiation Date
October 17, 2018
Termination Date
June 4, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-137-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide.

Code Information

Lots: C245 BUD: 11/28/2018; D005 BUD: 1/5/2019; D027 BUD: 1/31/2019; D035 BUD: 2/9/2019; D058 BUD: 3/9/2019

Other recalls by Qualgen, LLC

  • D-0517-2025 Class III — Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded prod (June 16, 2025)
  • D-0230-2019 Class II — Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 1 (October 17, 2018)
  • D-0236-2019 Class II — Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06) (October 17, 2018)
  • D-0229-2019 Class II — Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 1 (October 17, 2018)
  • D-0237-2019 Class II — Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-0 (October 17, 2018)
  • D-0234-2019 Class II — Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: (October 17, 2018)
  • D-0233-2019 Class II — Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06 (October 17, 2018)
  • D-0232-2019 Class II — Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-0 (October 17, 2018)
  • D-0225-2019 Class II — Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 1 (October 17, 2018)
  • D-0227-2019 Class II — Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 1 (October 17, 2018)