What does Class III mean?

Class III is FDA's low risk recall category: use of or exposure to the product is not likely to cause adverse health consequences.

Is this recall still active?

The FDA lists the recall as terminated (closed 06/16/2017). FDA has determined the recall is complete and closed it.

Checked Oct 26, 2026

Class IIIDrug recallTerminated

PYRIDOXINE HCL recall

Recalled by Medaus, Inc. of Birmingham, AL · FDA report 07/20/2016

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class: Class III; Low risk
Status: Terminated; Closed 06/16/2017
Recall started: 05/13/2016
Distribution: Nationwide

Reason for recall

Lack of Assurance of Sterility

Class III: Use of or exposure to the product is not likely to cause adverse health consequences.

Recalled product

Product: PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY
Lot and code info: Lot #: 151220-6, BUD: 06/17/16, Lot #: 160225-7, BUD: 08/23/16
Quantity: 4000 mL in Vials
Recall number: D-1236-2016
Event ID: 74466
Initiated by: Voluntary: Firm initiated

Where it was distributed

U.S. Nationwide, Japan, and New Zealand.

Nationwide

Recall timeline

05/13/2016Firm started the recall
07/08/2016FDA classified it as Class III
07/20/2016Published in the FDA enforcement report
06/16/2017FDA closed (terminated) the recall

All products in this recall

88 products under event 74466

More recalls from Medaus

Class IIDrug09/25/2013Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183Medaus, Inc. · 8 products · Lack of Assurance of Sterility: The product lots are being...

Frequently asked questions

Why was PYRIDOXINE HCL recalled?: Lack of Assurance of Sterility
What does Class III mean?: Class III is FDA's low risk recall category: use of or exposure to the product is not likely to cause adverse health consequences.
Where was the recalled product sold?: U.S. Nationwide, Japan, and New Zealand.
Is this recall still active?: The FDA lists the recall as terminated (closed 06/16/2017). FDA has determined the recall is complete and closed it.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 07/20/2016 · Do not rely on openFDA to make decisions regarding medical care

Recall at a glance

Class: Class III
Status: Terminated
Type: Drug
Reported: 07/20/2016

FDA enforcement report search

What recall classes mean

Class IMost serious: A reasonable chance that using or being exposed to the product will cause serious health problems or death.
Class IIModerate: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Class IIILow risk: Use of or exposure to the product is not likely to cause adverse health consequences.

Classes are assigned by the FDA based on the health hazard.

If you have a recalled product

Stop using or eating it. Check the lot number, UPC or date code against the recall.
Return it to the store or follow the firm's instructions for a refund, repair or disposal.
For medicines, talk to your pharmacist or doctor before stopping a prescription.
Report problems to the FDA through MedWatch or to the CPSC at SaferProducts.gov.

Browse recalls

About this data

Recalls: Recall information comes from NHTSA, FDA, USDA, CPSC and other agencies. A product, vehicle or lot may be affected even if it is not listed here, and listings may be delayed. Check the official recall notice and contact the manufacturer or dealer to confirm whether your item is included.

DatenUS is a private website and is not affiliated with or endorsed by any government agency. We republish public data from the sources listed on this page. Data can be incomplete, delayed or wrong. Always check the original source before you make a decision.

Our servers read this data automatically from government sources. Errors can come from the source itself or from the way we read, process or display it, and we do not guarantee that it is accurate, complete or current. Verify anything important with the official source.

Report an error Read the full disclaimer