D-1098-2014 Class II Terminated
FDA drug recall D-1098-2014 was initiated by Natures Pharmacy & Compounding Center on November 1, 2013 and is designated Class II. Reason for recall: 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 st… The recall status is terminated (terminated April 24, 2014). Affected quantity: 104 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- March 12, 2014
- Initiation Date
- November 1, 2013
- Termination Date
- April 24, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 104 syringes
Product Description
Lidocaine 4% Urethral Gel
Reason for Recall
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.
Distribution Pattern
NC
Code Information
Lot# 101213, Exp. 04/14 Lot# 09202013, Exp. 03/14 Lot# 08272013, Exp. 02/14 Lot# 08022013, Exp. 01/14