Class II · Moderate risk
SIH-Testosterone Cypionate 200 mg/mL Injectable
Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory
FDA Drug Recalls
657 recalls, newest first
Class II · Moderate risk
Estradiol 1.25 mg
Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory.
Class I · High risk
Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution
Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution may not be effective through expiry.
Class II · Moderate risk
Histamine
Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
Sodium Phosphate Injectable
Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
Pge-1
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Class II · Moderate risk
Pge-1
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Class II · Moderate risk
Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Class II · Moderate risk
Testosterone CYP
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Class II · Moderate risk
Testosterone Cypionate
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Class II · Moderate risk
0.5% Bupivacaine HCl and Epinephrine 1:200
Lack of Assurance of Sterility; potential for vial breakage
Class II · Moderate risk
Bevacizumab 25mg/mL
Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate.
Class II · Moderate risk
Hydroxocobalamin MDV 5 mg/mL
Lack of Assurance of Sterility: The pharmacy is recalling one lot of Hydroxocobalamin MDV 5mg/mL due to failed sterility results by a third party contract testing lab. Hence the sterility of the product cannot be assured.
Class II · Moderate risk
Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Class II · Moderate risk
Bevacizumab
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
Hyaluron (hyaluronidase)
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Class II · Moderate risk
Dextrose 50% Preservative Free SDV Injection Solution
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Class II · Moderate risk
EDTA disodium 150 mg/mL Sterile Injection
Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility.
Class II · Moderate risk
Lidocaine 1% PF Sterile Injection
Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility.
Class II · Moderate risk
Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection
Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate sterile injection due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.
Class II · Moderate risk
NA Ascorbate 500 mg/mL
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
NA Ascorbate 500 mg/mL
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
Magnesium Chl 200 mg/mL PF
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
Pyridoxine HCL 100 mg/mL NS
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
L-Glutathione 200 mg/mL PF
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.