Multi-event April 2013 FDA Recall Drug by Nora Apothecary And Alternative Therapies, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Nora Apothecary And Alternative Therapies, Inc. on April 22, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
D-458-2013 D-466-2013 D-492-2013 D-467-2013 D-482-2013 D-479-2013 D-470-2013 D-453-2013 D-454-2013 D-488-2013 D-483-2013 D-491-2013 D-484-2013 D-481-2013 D-494-2013 D-493-2013 D-468-2013 D-490-2013 D-480-2013 D-460-2013 D-465-2013 D-469-2013 D-478-2013 D-476-2013 D-475-2013 D-474-2013 D-472-2013 D-464-2013 D-461-2013 D-477-2013 D-456-2013 D-471-2013 D-486-2013 D-459-2013 D-495-2013 D-457-2013 D-485-2013 D-487-2013 D-489-2013 D-463-2013 D-473-2013 D-462-2013 D-455-2013
Recall Number: D-458-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
37
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-466-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-492-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-467-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-482-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-479-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-470-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-453-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
5
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30 and 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-454-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
5
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-488-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
5
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-483-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
14
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutaneous, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-491-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-484-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
11
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-481-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-494-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Meperidine 100mg/ml MDV, 5ml 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-493-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lidocaine 2% Inj MDV, 20 ml 30 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-468-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-490-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-480-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
7
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-460-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-465-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-469-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-478-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
HCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-476-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
3
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-475-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Folic Acid Inj 5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-474-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-472-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Chlorhexidine Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-464-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
1
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-461-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-477-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
3
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-456-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
8
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-471-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-486-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
3
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-459-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-495-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pyridoxine 100mg/ml Inj MDV, 1X30 ml 30 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-457-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-485-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-487-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
5
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr Subcutaneous, 30 and 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-489-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
2
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-463-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-473-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
7
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-462-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
72
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
Recall Number: D-455-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
04-22-2013
06-05-2013
128
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nora Apothecary and Alternative Therapies, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration,
Batch or Lot Expiration Information
Lot# All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
