Class II · Moderate risk
SIU-Papaverine 30 mg/mL Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
FDA Drug Recalls
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Class II · Moderate risk
SIH-Testosterone Cyp. 20 mg/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
S-methylcobalamin 25 mg/mL
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIH-Testosterone Cyp. 200 mg/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
S-Chorionic Gonad HCG 1000 U/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
S-Methylcobalamin 1000 mcg/mL
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
Absorica (isotretinoin)
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Class III · Low risk
Desmopressin Acetate Tablets
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Class III · Low risk
Desmopressin Acetate Tablets
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Class III · Low risk
Cortisol-Mc
Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
Class II · Moderate risk
c-Budesonide 0.6MG capsules
Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules.
Class III · Low risk
Disulfiram tablets
Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.
Class II · Moderate risk
Methylcobalamin 1
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Lidocaine/Sodium Chloride 0.4%/20% Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Hydroxocobalamin
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Doxycycline/0.9% NaCl 300 mg/500 mL IV
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Papaverine/Phentolamine/Atropine/PGE-1 Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Methadone 10 mg/mL Injection
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Phenol 6% Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Glycerin (v/v)
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Morphine/0.9 % NaCl 1 mg/mL IV
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Dexamethasone 24 mg/mL Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Doxycycline/0.9% NaCl 150 mg/250 mL IV
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Papervine/Phentolamine/PGE-1 Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.