Why it was recalled
Lack of Assurance of Sterility
Product description
TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML, and e) 5ML Vials, MEDAUS PHARMACY
Lot numbers, UPCs & expiration codes
a) Lot #151210-5, BUD: 06/07/16; Lot #160204-31, BUD: 08/02/16; Lot #160107-8, BUD: 07/05/16; Lot #160303-47, BUD: 08/30/16. b) Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160303-47, BUD: 08/30/16. c) Lot #151207-8, BUD: 06/04/16; Lot #160303-47, BUD: 08/30/16; Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160106-34, BUD: 07/04/16; Lot#160208-22, BUD: 08/06/16. d) Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160303-47, BUD: 08/30/16. e) Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160303-47, BUD: 08/30/16.
Where it was sold
U.S. Nationwide, Japan, and New Zealand.
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-1242-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 13, 2016
- FDA report date
- Jul 20, 2016
- Quantity
- 8000 mL in Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medaus, Inc.
Original FDA data
Every field from FDA enforcement report D-1242-2016, exactly as published.
Show all FDA fields
- City
- Birmingham
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 74466
- Address
- 6801 Cahaba Valley Rd Ste 116
- Code information
- a) Lot #151210-5, BUD: 06/07/16; Lot #160204-31, BUD: 08/02/16; Lot #160107-8, BUD: 07/05/16; Lot #160303-47, BUD: 08/30/16. b) Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160303-47, BUD: 08/30/16. c) Lot #151207-8, BUD: 06/04/16; Lot #160303-47, BUD: 08/30/16; Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160106-34, BUD: 07/04/16; Lot#160208-22, BUD: 08/06/16. d) Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160303-47, BUD: 08/30/16. e) Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160303-47, BUD: 08/30/16.
- Postal code
- 35242-9609
- Report date
- Jul 20, 2016
- Product type
- Drugs
- Recall number
- D-1242-2016
- Classification
- Class II
- Recalling firm
- Medaus, Inc.
- Product quantity
- 8000 mL in Vials
- Termination date
- Jun 16, 2017
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML, and e) 5ML Vials, MEDAUS PHARMACY
- Distribution pattern
- U.S. Nationwide, Japan, and New Zealand.
- Recall initiation date
- May 13, 2016
- Initial firm notification
- Center classification date
- Jul 8, 2016