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Class II: temporary or reversible health riskTerminated

Nora Apothecary and Alternative Therapies Hydroxycobalamin Inj 1 mcg/ml MDV Recall

Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,

Nora Apothecary and Alternative Therapies, Inc. · Indianapolis, IN

Risk level
Class II
Reported by FDA
Jun 5, 2013
Recall ID
D-481-2013
Check your lot numberHow we source this data

Summary

Nora Apothecary and Alternative Therapies recalled Hydroxycobalamin Inj 1 mcg/ml MDV starting Apr 22, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-481-2013 on Jun 5, 2013. Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Product description

Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,

Lot numbers, UPCs & expiration codes

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Where it was sold

Nationwide

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-481-2013
Classification
Class II
Status
Terminated
Recall initiated
Apr 22, 2013
FDA report date
Jun 5, 2013
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
Nora Apothecary and Alternative Therapies, Inc.

Original FDA data

Every field from FDA enforcement report D-481-2013, exactly as published.

Show all FDA fields
City
Indianapolis
State
IN
Status
Terminated
Country
United States
Event ID
65019
Address
1101 E 86th St
Code information
All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Postal code
46240-3729
Report date
Jun 5, 2013
Product type
Drugs
Recall number
D-481-2013
Classification
Class II
Recalling firm
Nora Apothecary and Alternative Therapies, Inc.
Termination date
Aug 1, 2014
Reason for recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
Distribution pattern
Nationwide
Recall initiation date
Apr 22, 2013
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
May 29, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-481-2013, published Jun 5, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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