CLASS II Drug recall · Reported 5 Jun 2013 · FDA Enforcement Report

Hydroxycobalamin Inj 1000mcg/ml MDV: Subcutaneous, 90 day recalled

Nora Apothecary and Alternative Therapies is recalling Hydroxycobalamin Inj 1000mcg/ml MDV: Subcutaneous, 90 day, distributed nationwide in the US. The recall was initiated on 22 Apr 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Quantity recalled7

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-480-2013
FDA event ID
65019
Recalling firm
Nora Apothecary and Alternative Therapies, Indianapolis, IN
Classification
Class II
Status
Terminated
Recall initiated
22 Apr 2013
FDA classified
29 May 2013
Reported
5 Jun 2013
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Sterility

Timeline

22 Apr 2013Recall initiated by company
29 May 2013Classified by FDA+37 days
5 Jun 2013Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous, 90 day expiration,

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

42 other products · FDA event 65019

This product is part of a recall event; the main page for the event is Renacidin Irrigation: Bladder Irrigation, 30 day recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIRenacidin Irrigation: Bladder Irrigation, 30 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIPapaverine Inj 30mg/ml Syr, 5mlsyr recalled by Nora Apothecary andNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IITobramycin Opth Soln 13mg/ml Opthalmic Soln, 10 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IITrimix Inj 30:1:40 MDV Penile Injection, 30 and 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IITrimix Inj 30:3:5 MDV Penile Injection, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIPGE-1 Inj 10mcg/ml MDV Penile Injection, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IITrimix Inj Form MDV Penile Injection, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIHCG Inj 500un/ml MDV Subcutaneous, 30 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIGlutathione 200mg/ml Inj SDV: 3x50ml 14 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIVancomycin Opth Soln14mg/ml PF Opthalmic Soln, 30 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IITobramycin Opth Soln 14mg/ml Opthalmic Soln, 10 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIPGE-1 Inj 40mcg/ml MDV Penile Injection, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIPGE-1 Inj 20mcg/ml MDV: Penile Injection, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIBimix Inj 30 :1 Syr, . syr, . syr, ml syr, ml syr, 12x recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIMethylcobalamin Inj 5mg/ml MDV: Subcutaneous, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IITrimix Inj 30:1:10 MDV Penile Injection, 30 and 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIBimix Inj 30:0.5 MDV syr Penile Injection, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIMethylcobalamin Inj 2.5mg/ml MDV Subcutaneous, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIHCG Inj 1250 un/ml MDV Subcutaneous, 30 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIHydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IISuper Trimix #1 Inj MDV Penile Injection, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIVancomycin Opth Soln 30mg/ml PRES Opthalmic Soln, 30 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIDexamethasone Opth Soln 0.1% PF Opthalmic Soln, 30 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIMethylcobalamin 5mg/ml Inj Syr, .4syr Subcutaneous, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IITrimix Inj 30:1:20 MDV:, ml Penile Injection, 30 and 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIPGE-1 Inj 30mcg/ml MDV Penile Injection, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIHCG Inj 1000un/ml MDV: Subcutaneous, 30 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIM.I.C.+B12 Inj MDV: 3x50ml, ml 90 day recalled by Nora Apothecary andNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIVancomycin Opth Soln 25mg/ml PF Opthalmic Soln, 10 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIGentamicin 24mg/ Irrigation, 15x60ml Syr Irrigation, 14 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIBimix Inj 30:1 MDV:, 3x10ml, 2x10ml Penile Injection, 30 and 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIPyridoxine 100mg/ml Inj MDV, ml 30 day recalled by Nora Apothecary andNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIMeperidine 100mg/ml MDV 90 day recalled by Nora Apothecary andNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IILidocaine 2% Inj MDV 30 day recalled by Nora Apothecary andNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIMethylcobalamin Inj 25mg/ml Syr: .06mlsyr, . syr recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIHydroxyprogesterone Inj 250mg/ml MDV Intramuscular, 30 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIFolic Acid Inj 5mg/ml MDV Subcutaneous, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIMethylcobalamin Inj 1mg/ml MDV, ml Subcutaneous, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIPHMB Opth Soln 0.02% Opthalmic Soln, 30 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIHydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIChlorhexidine Opth Soln 0.02% Opthalmic Soln, 30 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
CLASS IIHCG Inj 1200un/ml MDV Subcutaneous, 30 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide

More recalls from Nora Apothecary and Alternative Therapies

All 43
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIHCG Inj 1200un/ml MDV Subcutaneous, 30 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
DrugCLASS IIChlorhexidine Opth Soln 0.02% Opthalmic Soln, 30 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
DrugCLASS IIHydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
DrugCLASS IIPHMB Opth Soln 0.02% Opthalmic Soln, 30 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
DrugCLASS IIMethylcobalamin Inj 1mg/ml MDV, ml Subcutaneous, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide

Other Hydroxycobalamin Inj recalls

All 3
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIHydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide
DrugCLASS IIHydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day recalledNora Apothecary and Alternative TherapiesSterilityNationwide