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).
Goal-Glutamine 75mg/Ornithine 75mg/Arginine 150mg/Lysine…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of assurance of sterility
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
GOAL-GLUTAMINE 75MG/ORNITHINE 75MG/ARGININE 150MG/LYSINE 150MG+LIDOCAINE 10MG/ML 75MG/75MG/150MG/150MG/10MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Drug: Lidocaine
- Recalling firm
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0116-2022 · 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 Vita Pharmacy, LLC dba Talon Compounding Pharmacy
All 2021 recalls
Class II · Moderate risk
Tri-Mix Papaverine 40/Phentolamine 2/Pge-1 40 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Tri-Mix Papaverine 40/Phentolamine 2/Pge-1 10 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Tri-Mix Papaverine 30/Phentolamine 6/Pge-1 60 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 7.5/Ml Inj Injectable
Lack of assurance of sterility
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