Recalls / Class II
Class IID-1098-2014
Product
Lidocaine 4% Urethral Gel
- Affected lot / code info
- Lot# 101213, Exp. 04/14 Lot# 09202013, Exp. 03/14 Lot# 08272013, Exp. 02/14 Lot# 08022013, Exp. 01/14
Why it was recalled
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recalling firm
- Firm
- Natures Pharmacy & Compounding Center
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 752 Biltmore Ave, Asheville, North Carolina 28803-2558
Distribution
- Quantity
- 104 syringes
- Distribution pattern
- NC
Timeline
- Recall initiated
- 2013-11-01
- FDA classified
- 2014-03-04
- Posted by FDA
- 2014-03-12
- Terminated
- 2014-04-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1098-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.