Why it was recalled
Lack of Assurance of Sterility
Product description
NA ASCORBATE 500MG/ML NON-CORN (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY
Lot numbers, UPCs & expiration codes
a) Lot #: 151201-30, BUD: 05/29/16; Lot #: 151209-26, BUD: 06/06/16; Lot #: 151216-63, BUD: 06/13/16; Lot #: 151231-11, BUD: 06/28/16; Lot #: 160105-4, BUD: 07/03/16; Lot #: 160125-41, BUD: 07/23/16; Lot #: 160211-20, BUD: 08/09/16. b) Lot #: 151201-30, BUD: 05/29/16; Lot #: 151209-26, BUD: 06/06/16; Lot #: 151216-63, BUD: 06/13/16; Lot #: 151231-11, BUD: 06/28/16; Lot #: 160105-4, BUD: 07/03/16; Lot #: 160125-41, BUD: 07/23/16; Lot #: 160511-20, BUD: 08/09/16. c) Lot #: 151201-30, BUD: 05/29/16; Lot #: 151209-26, BUD: 06/06/16; Lot #: 151216-63, BUD: 06/13/16; Lot #: 151231-11, BUD: 06/28/16; Lot #: 160105-4, BUD: 07/03/16; Lot #: 160125-41, BUD: 07/23/16; Lot #: 160511-20, BUD: 08/09/16.
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-1229-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 13, 2016
- FDA report date
- Jul 20, 2016
- Quantity
- 358000 mL in Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medaus, Inc.
Original FDA data
Every field from FDA enforcement report D-1229-2016, 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 #: 151201-30, BUD: 05/29/16; Lot #: 151209-26, BUD: 06/06/16; Lot #: 151216-63, BUD: 06/13/16; Lot #: 151231-11, BUD: 06/28/16; Lot #: 160105-4, BUD: 07/03/16; Lot #: 160125-41, BUD: 07/23/16; Lot #: 160211-20, BUD: 08/09/16. b) Lot #: 151201-30, BUD: 05/29/16; Lot #: 151209-26, BUD: 06/06/16; Lot #: 151216-63, BUD: 06/13/16; Lot #: 151231-11, BUD: 06/28/16; Lot #: 160105-4, BUD: 07/03/16; Lot #: 160125-41, BUD: 07/23/16; Lot #: 160511-20, BUD: 08/09/16. c) Lot #: 151201-30, BUD: 05/29/16; Lot #: 151209-26, BUD: 06/06/16; Lot #: 151216-63, BUD: 06/13/16; Lot #: 151231-11, BUD: 06/28/16; Lot #: 160105-4, BUD: 07/03/16; Lot #: 160125-41, BUD: 07/23/16; Lot #: 160511-20, BUD: 08/09/16.
- Postal code
- 35242-9609
- Report date
- Jul 20, 2016
- Product type
- Drugs
- Recall number
- D-1229-2016
- Classification
- Class II
- Recalling firm
- Medaus, Inc.
- Product quantity
- 358000 mL in Vials
- Termination date
- Jun 16, 2017
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NA ASCORBATE 500MG/ML NON-CORN (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML 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