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.
Product description
Lidocaine 4% Urethral Gel
Lot numbers, UPCs & expiration codes
Lot# 101213, Exp. 04/14 Lot# 09202013, Exp. 03/14 Lot# 08272013, Exp. 02/14 Lot# 08022013, Exp. 01/14
Where it was sold
NC
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1098-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 1, 2013
- FDA report date
- Mar 12, 2014
- Quantity
- 104 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Natures Pharmacy & Compounding Center
Original FDA data
Every field from FDA enforcement report D-1098-2014, exactly as published.
Show all FDA fields
- City
- Asheville
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 66856
- Address
- 752 Biltmore Ave
- Code information
- Lot# 101213, Exp. 04/14 Lot# 09202013, Exp. 03/14 Lot# 08272013, Exp. 02/14 Lot# 08022013, Exp. 01/14
- Postal code
- 28803-2558
- Report date
- Mar 12, 2014
- Product type
- Drugs
- Recall number
- D-1098-2014
- Classification
- Class II
- Recalling firm
- Natures Pharmacy & Compounding Center
- Product quantity
- 104 syringes
- Termination date
- Apr 24, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine 4% Urethral Gel
- Distribution pattern
- NC
- Recall initiation date
- Nov 1, 2013
- Initial firm notification
- Telephone
- Center classification date
- Mar 4, 2014