Why it was recalled
Lack of Assurance of Sterility
Product description
B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, LIDOCAINE 1%, METHYL B12 1MG/ML, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
Lot numbers, UPCs & expiration codes
a) Lot #: 151228-62, BUD: 06/25/16. b) Lot #: 160111-2, BUD: 06/11/16; Lot #: 160113-3, BUD: 06/11/16; Lot #: 160113-76, BUD: 06/11/16; Lot #: 160118-1, BUD: 06/11/16; Lot #: 160119-2, BUD: 06/11/16; Lot #: 160119-65, BUD: 06/11/16; Lot #: 160122-9, BUD: 06/11/16; Lot #: 160128-10, BUD: 06/11/16; Lot #: 160202-65, BUD: 06/11/16; Lot #: 160204-44, BUD: 06/11/16; Lot #: 160217-54, BUD: 06/11/16; Lot #: 160223-5, BUD: 06/11/16; Lot #: 160224-66, BUD: 06/11/16; Lot #: 160229-23, BUD: 06/11/16; Lot #: 160315-3, BUD: 06/11/16. c) Lot #: 160118-1, BUD: 06/11/16; Lot #: 160127-2, BUD: 06/11/16; Lot #: 160210-37, BUD: 06/11/16; Lot #: 160223-5, BUD: 06/11/16; Lot #: 160310-14, BUD: 06/11/16.
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-1175-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 13, 2016
- FDA report date
- Jul 20, 2016
- Quantity
- 370 mL in Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medaus, Inc.
Original FDA data
Every field from FDA enforcement report D-1175-2016, 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 #: 151228-62, BUD: 06/25/16. b) Lot #: 160111-2, BUD: 06/11/16; Lot #: 160113-3, BUD: 06/11/16; Lot #: 160113-76, BUD: 06/11/16; Lot #: 160118-1, BUD: 06/11/16; Lot #: 160119-2, BUD: 06/11/16; Lot #: 160119-65, BUD: 06/11/16; Lot #: 160122-9, BUD: 06/11/16; Lot #: 160128-10, BUD: 06/11/16; Lot #: 160202-65, BUD: 06/11/16; Lot #: 160204-44, BUD: 06/11/16; Lot #: 160217-54, BUD: 06/11/16; Lot #: 160223-5, BUD: 06/11/16; Lot #: 160224-66, BUD: 06/11/16; Lot #: 160229-23, BUD: 06/11/16; Lot #: 160315-3, BUD: 06/11/16. c) Lot #: 160118-1, BUD: 06/11/16; Lot #: 160127-2, BUD: 06/11/16; Lot #: 160210-37, BUD: 06/11/16; Lot #: 160223-5, BUD: 06/11/16; Lot #: 160310-14, BUD: 06/11/16.
- Postal code
- 35242-9609
- Report date
- Jul 20, 2016
- Product type
- Drugs
- Recall number
- D-1175-2016
- Classification
- Class II
- Recalling firm
- Medaus, Inc.
- Product quantity
- 370 mL in Vials
- Termination date
- Jun 16, 2017
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, LIDOCAINE 1%, METHYL B12 1MG/ML, In a) 1ML Vials, b) 5ML Vials, and c) 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