Class I - Dangerous
Marketed without an Approved NDA/ANDA
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Other Drugs
💊 Drugs • 3,200 recalls
Class I - Dangerous
Marketed without an Approved NDA/ANDA
Class I - Dangerous
Marketed without an Approved NDA/ANDA
Class I - Dangerous
Marketed without an Approved NDA/ANDA
Class I - Dangerous
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
Spectrum Laboratory Products
Class I - Dangerous
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
Class I - Dangerous
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class I - Dangerous
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe. KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678375
KRS Global Biotechnology
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
cGMP Deviations: Potential glass contamination
Class I - Dangerous
cGMP Deviations: Potential glass contamination
Class I - Dangerous
cGMP Deviations: Potential glass contamination
Class I - Dangerous
Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles
Compounded Solutions in Pharmacy
Class I - Dangerous
Lack of Processing Controls:
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.
Compounded Solutions in Pharmacy
Class I - Dangerous
Lack of Processing Controls:
5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles
Compounded Solutions in Pharmacy
Class I - Dangerous
Lack of Processing Controls:
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.