Class II · Moderate risk
Lidocaine Ointment USP
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Sodium Bicarbonate and Lidocaine Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Sodium Bicarbonate and Lidocaine Injection, all strengths and all presentations including Sod-Bicarb-Lido-0.27-2.73-3 syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Drug: Lidocaine
- Recalling firm
- FVS Holdings, Inc. dba. Green Valley Drugs
- Origin
- NV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-405-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Lidocaine recalls
See all
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Lidocaine HCl Injection
Presence of Particulate Matter: Hair was found in products
Class III · Low risk
Lidolog Kit
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Other recalls by FVS Holdings, Inc. dba. Green Valley Drugs
All 2013 recalls
Class II · Moderate risk
Zinc Sulfate Injection
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
Triamcinolone Injection
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
Thiamine Hydrochloride Injection
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
Testosterone Cypionate Injection
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
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