Medaus M.i.c B-complex Premix W/hydroxy W/pres Hydroxy Recall

Why it was recalled

Lack of Assurance of Sterility

Product description

M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG, B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG, METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY

Lot numbers, UPCs & expiration codes

Lot #: 160229-24, BUD: 07/25/16, Lot #: 160315-5, BUD: 07/25/16

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-1222-2016
Classification: Class II
Status: Terminated
Recall initiated: May 13, 2016
FDA report date: Jul 20, 2016
Quantity: 110 mL in Vials
Recall type: Voluntary: Firm initiated
Recalling firm: Medaus, Inc.

Original FDA data

Every field from FDA enforcement report D-1222-2016, 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 #: 160229-24, BUD: 07/25/16, Lot #: 160315-5, BUD: 07/25/16
Postal code: 35242-9609
Report date: Jul 20, 2016
Product type: Drugs
Recall number: D-1222-2016
Classification: Class II
Recalling firm: Medaus, Inc.
Product quantity: 110 mL in Vials
Termination date: Jun 16, 2017
Reason for recall: Lack of Assurance of Sterility
Voluntary / mandated: Voluntary: Firm initiated
Product description: M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG, B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG, METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1222-2016, published Jul 20, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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Medaus M.I.C B-Complex Premix W/Hydroxy B12 W/Pres. Recall

Summary