D-477-2013 Class II Terminated
FDA drug recall D-477-2013 was initiated by Nora Apothecary and Alternative Therapies, Inc. on April 22, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. The recall status is terminated (terminated August 1, 2014). Affected quantity: 3.
Recall Details
- Product Type
- Drugs
- Report Date
- June 5, 2013
- Initiation Date
- April 22, 2013
- Termination Date
- August 1, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration,
Reason for Recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Distribution Pattern
Nationwide
Code Information
All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).