Home / Recalls / Qualgen, LLC / D-0892-2018

D-0892-2018 Class III Terminated

Recalled by Qualgen, LLC — Edmond, OK

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
2,940 pellets

Product Description

ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01

Reason for Recall

Labeling: Incorrect or Missing Lot and/or Exp Date.

Distribution Pattern

Nationwide in the USA

Code Information

lot# C211 Exp. date 10/03/2018; C257 Exp. date 12/14/2018 and lot # D001 exp. date 01/02/19

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-0234-2019 Class II — Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: (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-0235-2019 Class II — Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137- (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-0237-2019 Class II — Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-0 (October 17, 2018)