Nephron Sterile Compounding Center Ketamine Hydrochloride Injection, USP, 50 mg/5 mL recall — FDA D-0960-2022
Lack of Assurance of Sterility
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lack of Assurance of Sterility
cGMP deviations: product stored outside of labeled temperature requirements.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lack of Assurance of Sterility
cGMP deviations: product stored outside of labeled temperature requirements.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.
Lack of assurance of sterility.
Defective Delivery System: customer complaints exceeded respective action limits.
Lack of assurance of sterility.
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.