Ranier's Compounding Laboratory Avastin 1.25 mg/0.05 mL prefilled syringe recall — FDA D-1082-2018
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
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.
10,690 detailed records are currently available in this category.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Microbial Contamination of a Non-Sterile Product
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin…
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
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.
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