Status
Terminated
Drug Enforcement D-456-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Classification
Class II
Report Date
June 5, 2013
Termination Date
August 1, 2014
Product Information
- Product description
- Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration,
- Product quantity
- 8
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Nora Apothecary and Alternative Therapies, Inc.
- Address
-
1101 E 86th St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-456-2013
- Event ID
- 65019
- Recall initiation date
- April 22, 2013
- Center classification date
- May 29, 2013
- Code info
- All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).
- More code info
- —