Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Innoveix Pharmaceuticals
Class I - Dangerous
Lack of Sterility Assurance.
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Prescription Drugs
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Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Innoveix Pharmaceuticals
Class I - Dangerous
Lack of Sterility Assurance.
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
Nephron Pharmaceuticals Corporation
Class I - Dangerous
Lack of Assurance of Sterility; bags have potential to leak
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25
Nephron Pharmaceuticals Corporation
Class I - Dangerous
GMP Deviations: potential glass contamination
PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25
Nephron Pharmaceuticals Corporation
Class I - Dangerous
GMP Deviations: potential glass contamination
del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10
Nephron Pharmaceuticals Corporation
Class I - Dangerous
Lack of Assurance of Sterility; bags have potential to leak
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20
Nephron Pharmaceuticals Corporation
Class I - Dangerous
GMP Deviations: potential glass contamination
Class I - Dangerous
Presence of Foreign Substance; Fiber particles.
Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 711 E Carefree Hwy, Suite 107, Phoenix, AZ 85085, NDC 71591-500-50.
Atlas Pharmaceuticals
Class I - Dangerous
Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839
Ingenus Pharmaceuticals
Class I - Dangerous
Crystallization: Presence of particulate matter identified as API crystallization
Class I - Dangerous
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Class I - Dangerous
Superpotent
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Class I - Dangerous
Lack of Assurance of Sterility: Bag has the potential to leak.
Class I - Dangerous
Microbial Contamination of Non-Sterile Product.
Class I - Dangerous
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class I - Dangerous
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class I - Dangerous
Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
Class I - Dangerous
GMP Deviation: lot not intended for commercial distribution.