Medaus B-complex Without W/pres Recall: FDA Class II

Why it was recalled

Lack of Assurance of Sterility

Product description

B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Lot numbers, UPCs & expiration codes

a) Lot #: 151222-11, BUD: 05/28/16; Lot #: 151224-5, BUD: 05/28/16; Lot #: 160111-1, BUD: 05/28/16; Lot #: 160119-3, BUD: 05/28/16; Lot #: 160119-64, BUD: 05/28/16; Lot #: 160217-10, BUD: 05/28/16; Lot #: 160307-22, BUD: 05/28/16. b) Lot #: 151223-30, BUD: 05/28/16; Lot #: 151224-2, BUD: 05/28/16; Lot #: 160111-1, BUD: 05/28/16; Lot #: 160112-2, BUD: 05/28/16; Lot #: 160118-2, BUD: 05/28/16; Lot #: 160119-64, BUD: 05/28/16; Lot #: 160125-1, BUD: 05/28/16; Lot #: 160208-4, BUD: 05/28/16; Lot #: 160210-64, BUD: 05/28/16; Lot #: 160215-6, BUD: 05/28/16; Lot #: 160222-14, BUD: 05/28/16; Lot #: 160307-22, BUD: 05/28/16; Lot #: 160307-23, 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-1171-2016
Classification: Class II
Status: Terminated
Recall initiated: May 13, 2016
FDA report date: Jul 20, 2016
Quantity: 955 mL in Vials
Recall type: Voluntary: Firm initiated
Recalling firm: Medaus, Inc.

Original FDA data

Every field from FDA enforcement report D-1171-2016, 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 #: 151222-11, BUD: 05/28/16; Lot #: 151224-5, BUD: 05/28/16; Lot #: 160111-1, BUD: 05/28/16; Lot #: 160119-3, BUD: 05/28/16; Lot #: 160119-64, BUD: 05/28/16; Lot #: 160217-10, BUD: 05/28/16; Lot #: 160307-22, BUD: 05/28/16. b) Lot #: 151223-30, BUD: 05/28/16; Lot #: 151224-2, BUD: 05/28/16; Lot #: 160111-1, BUD: 05/28/16; Lot #: 160112-2, BUD: 05/28/16; Lot #: 160118-2, BUD: 05/28/16; Lot #: 160119-64, BUD: 05/28/16; Lot #: 160125-1, BUD: 05/28/16; Lot #: 160208-4, BUD: 05/28/16; Lot #: 160210-64, BUD: 05/28/16; Lot #: 160215-6, BUD: 05/28/16; Lot #: 160222-14, BUD: 05/28/16; Lot #: 160307-22, BUD: 05/28/16; Lot #: 160307-23, BUD: 06/11/16.
Postal code: 35242-9609
Report date: Jul 20, 2016
Product type: Drugs
Recall number: D-1171-2016
Classification: Class II
Recalling firm: Medaus, Inc.
Product quantity: 955 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 WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, 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: E-Mail
Center classification date: Jul 8, 2016

Medaus B-Complex Without B12 W/Pres Recall

Summary