Why it was recalled
Lack of Assurance of Sterility
Product description
SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Lot numbers, UPCs & expiration codes
Lot #: 151130-35, BUD: 05/21/16; Lot #: 151202-28, BUD: 05/21/16; Lot #: 151223-68, BUD: 05/21/16; Lot #: 151216-20, BUD: 05/21/16; Lot #: 151123-77, BUD: 05/21/16; Lot #: 151204-22, BUD: 05/21/16; Lot #: 160111-30, BUD: 05/21/16; Lot #: 160112-27, BUD: 05/21/16; Lot #: 160120-8, BUD: 05/21/16; Lot #: 160118-12, BUD: 05/21/16; Lot #: 160119-20, BUD: 05/21/16; Lot #: 160202-37, BUD: 05/21/16; Lot #: 160208-61, BUD: 05/21/16; Lot #: 160208-62, BUD: 05/21/16; Lot #: 160216-37, BUD: 08/14/16; Lot #: 160216-38, BUD: 08/14/16; Lot #: 160216-35, BUD: 08/14/16; Lot #: 160216-40, BUD: 08/14/16; Lot #: 160223-27, BUD: 08/14/16; Lot #: 160229-43, BUD: 08/14/16; Lot #: 160303-22, BUD: 08/14/16; Lot #: 160309-17, BUD: 08/14/16
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-1238-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 13, 2016
- FDA report date
- Jul 20, 2016
- Quantity
- 884 mL in Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medaus, Inc.
Original FDA data
Every field from FDA enforcement report D-1238-2016, 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
- Lot #: 151130-35, BUD: 05/21/16; Lot #: 151202-28, BUD: 05/21/16; Lot #: 151223-68, BUD: 05/21/16; Lot #: 151216-20, BUD: 05/21/16; Lot #: 151123-77, BUD: 05/21/16; Lot #: 151204-22, BUD: 05/21/16; Lot #: 160111-30, BUD: 05/21/16; Lot #: 160112-27, BUD: 05/21/16; Lot #: 160120-8, BUD: 05/21/16; Lot #: 160118-12, BUD: 05/21/16; Lot #: 160119-20, BUD: 05/21/16; Lot #: 160202-37, BUD: 05/21/16; Lot #: 160208-61, BUD: 05/21/16; Lot #: 160208-62, BUD: 05/21/16; Lot #: 160216-37, BUD: 08/14/16; Lot #: 160216-38, BUD: 08/14/16; Lot #: 160216-35, BUD: 08/14/16; Lot #: 160216-40, BUD: 08/14/16; Lot #: 160223-27, BUD: 08/14/16; Lot #: 160229-43, BUD: 08/14/16; Lot #: 160303-22, BUD: 08/14/16; Lot #: 160309-17, BUD: 08/14/16
- Postal code
- 35242-9609
- Report date
- Jul 20, 2016
- Product type
- Drugs
- Recall number
- D-1238-2016
- Classification
- Class II
- Recalling firm
- Medaus, Inc.
- Product quantity
- 884 mL in Vials
- Termination date
- Jun 16, 2017
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SELENIUM 200MCG/ML (PF), 10ML 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