Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date.
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
Lot numbers, UPCs & expiration codes
lot# D001 EXP: 01/02/2018 CPD: 01/02/2019
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0893-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 8, 2018
- FDA report date
- Jul 11, 2018
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualgen, LLC
Original FDA data
Every field from FDA enforcement report D-0893-2018, exactly as published.
Show all FDA fields
- City
- Edmond
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 80203
- Address
- 14844 Bristol Park Blvd
- Code information
- lot# D001 EXP: 01/02/2018 CPD: 01/02/2019
- Postal code
- 73013-1891
- Report date
- Jul 11, 2018
- Product type
- Drugs
- Recall number
- D-0893-2018
- Classification
- Class III
- Recalling firm
- Qualgen, LLC
- Termination date
- Nov 25, 2020
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 8, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 29, 2018