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Safecor Health, LLC Recall: Box labeled Thiamine Hydrochloride instead of Thiamine Mononitrate - F-0606-2017

United States

TerminatedClass III

Company
Safecor Health, LLC
Product
Safecor Vitamin B-1 (THIAMINE) 100 mg tablets NDC: 48433-01…
Recall date
September 12, 2016
Terminated
August 1, 2017
Source
FDA

Reason for recall

Box labeled Thiamine Hydrochloride instead of Thiamine Mononitrate

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
Safecor Vitamin B-1 (THIAMINE) 100 mg tablets NDC: 48433-0108-01 Distributed by: SAFECOR HEALTH, 317 NEW BOSTON STREET, WOBURN, MA Not published in this source record 1431 boxes Safecor Health Lot # A15012, A15021, 16A004, 16A015 and 16A035

Distribution

  • Nationwide

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-0606-2017
Event ID
75196
Status
Terminated
Classification
Class III
Company
Safecor Health, LLC
Product description
Safecor Vitamin B-1 (THIAMINE) 100 mg tablets NDC: 48433-0108-01 Distributed by: SAFECOR HEALTH, 317 NEW BOSTON STREET, WOBURN, MA
Quantity
1431 boxes
Reason
Box labeled Thiamine Hydrochloride instead of Thiamine Mononitrate
Recall initiation date
September 12, 2016
Report date
December 14, 2016
Classification date
Not published in this source record
Termination date
August 1, 2017
Distribution pattern
Nationwide
UPC, lot, and code information
Safecor Health Lot # A15012, A15021, 16A004, 16A015 and 16A035
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
Letter
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Responsible company: Safecor Health, LLC

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Metoclopramide Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 51079-886-20.

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Published
November 4, 2026
Distribution
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FDA Recall Ongoing2026 recordClass II

Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04

by Safecor Health, LLC

Published
September 23, 2026
Distribution
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FDA Recall Ongoing2026 recordClass II

Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04

by Safecor Health, LLC

Published
September 23, 2026
Distribution
Nationwide

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Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information. See FDA Enforcement Reports versus recall announcements for how that database differs from a press-release-style announcement.

New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class III mean?

FDA classifies this recall as Class III. See how to read an FDA recall record (linked above) for what each classification level means.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the responsible agency's published instructions, linked below -- recall guidance is set by that agency, not by Public Health Trace.

Official guidance and record verification

Public Health Trace does not provide medical advice -- review the linked official source below for current, authoritative information.

How to interpret this historical record

This record is preserved as published by FDA, as of August 1, 2017.

Status as reported: Terminated.

This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.

View the official FDA source

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.

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