Lidocaine 4% Urethral Gel Recalled Due to Sterility Assurance Concerns
Natures Pharmacy & Compounding Center is recalling Lidocaine 4% Urethral Gel due to quality control issues affecting sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving potential sterility risks.
Plain-English summary
Natures Pharmacy & Compounding Center is recalling 104 syringes of Lidocaine 4% Urethral Gel. The recall covers specific lots distributed in North Carolina (NC) with expiration dates ranging from January 2014 to April 2014.
The recall was initiated due to a lack of sterility assurance. This issue stems from quality control procedures observed during a recent FDA inspection that present a potential risk to the sterility of the compounded products.
Consumers who have purchased this product should stop using it and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Lidocaine 4% Urethral Gel
- Manufacturer
- Natures Pharmacy & Compounding Center
- Hazard
- Affected units
- 104
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot# 101213
- Exp. 04/14 Lot# 09202013
- Exp. 03/14 Lot# 08272013
- Exp. 02/14 Lot# 08022013
- Exp. 01/14
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 48 recalled by Natures Pharmacy & Compounding Center under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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