Why it was recalled
Lack of Assurance of Sterility
Product description
DMSO 99.9 (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Lot numbers, UPCs & expiration codes
a) Lot #: 151217-2, BUD: 05/30/16; Lot #: 160115-6, BUD: 05/30/16; Lot #: 160303-8, BUD: 08/30/16; Lot #: 160303-10, BUD: 08/30/16. b) Lot #: 151203-37, BUD: 05/30/16; Lot #: 151203-72, BUD: 05/30/16; Lot #: 151209-7, BUD: 05/30/16; Lot #: 151209-8, BUD: 05/30/16; Lot #: 151209-9, BUD: 05/30/16; Lot #: 151209-10, BUD: 05/30/16; Lot #: 151209-11, BUD: 05/30/16; Lot #: 151209-13, BUD: 05/30/16; Lot #: 151209-14, BUD: 05/30/16; Lot #: 160104-31, BUD: 05/30/16; Lot #: 160113-77, BUD: 05/30/16; Lot #: 151218-7, BUD: 06/15/16; Lot #: 151218-8, BUD: 06/15/16; Lot #: 160113-78, BUD: 07/11/16; Lot #: 160113-4, BUD: 07/11/16; Lot #: 160122-10, BUD: 07/20/16; Lot #: 160201-6, BUD: 07/30/16; Lot #: 160201-7, BUD: 07/30/16; Lot #: 160204-9, BUD: 08/02/16; Lot #: 160208-5, BUD: 08/06/16; Lot #: 160208-6, BUD: 08/06/16; Lot #: 160210-65, BUD: 08/08/16; Lot #: 160210-66, BUD: 08/08/16; Lot #: 160210-67, BUD: 08/08/16; Lot #: 160210-68, BUD: 08/08/16; Lot #: 160210-69, BUD: 08/08/16; Lot #: 160303-12, BUD: 08/30/16; Lot #: 160303-13, BUD: 08/30/16; Lot #: 160309-2, BUD: 09/05/16.
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-1181-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 13, 2016
- FDA report date
- Jul 20, 2016
- Quantity
- 2218 mL in Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medaus, Inc.
Original FDA data
Every field from FDA enforcement report D-1181-2016, 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 #: 151217-2, BUD: 05/30/16; Lot #: 160115-6, BUD: 05/30/16; Lot #: 160303-8, BUD: 08/30/16; Lot #: 160303-10, BUD: 08/30/16. b) Lot #: 151203-37, BUD: 05/30/16; Lot #: 151203-72, BUD: 05/30/16; Lot #: 151209-7, BUD: 05/30/16; Lot #: 151209-8, BUD: 05/30/16; Lot #: 151209-9, BUD: 05/30/16; Lot #: 151209-10, BUD: 05/30/16; Lot #: 151209-11, BUD: 05/30/16; Lot #: 151209-13, BUD: 05/30/16; Lot #: 151209-14, BUD: 05/30/16; Lot #: 160104-31, BUD: 05/30/16; Lot #: 160113-77, BUD: 05/30/16; Lot #: 151218-7, BUD: 06/15/16; Lot #: 151218-8, BUD: 06/15/16; Lot #: 160113-78, BUD: 07/11/16; Lot #: 160113-4, BUD: 07/11/16; Lot #: 160122-10, BUD: 07/20/16; Lot #: 160201-6, BUD: 07/30/16; Lot #: 160201-7, BUD: 07/30/16; Lot #: 160204-9, BUD: 08/02/16; Lot #: 160208-5, BUD: 08/06/16; Lot #: 160208-6, BUD: 08/06/16; Lot #: 160210-65, BUD: 08/08/16; Lot #: 160210-66, BUD: 08/08/16; Lot #: 160210-67, BUD: 08/08/16; Lot #: 160210-68, BUD: 08/08/16; Lot #: 160210-69, BUD: 08/08/16; Lot #: 160303-12, BUD: 08/30/16; Lot #: 160303-13, BUD: 08/30/16; Lot #: 160309-2, BUD: 09/05/16.
- Postal code
- 35242-9609
- Report date
- Jul 20, 2016
- Product type
- Drugs
- Recall number
- D-1181-2016
- Classification
- Class II
- Recalling firm
- Medaus, Inc.
- Product quantity
- 2218 mL in Vials
- Termination date
- Jun 16, 2017
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DMSO 99.9 (PF), In a) 5ML Vials and b) 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