Lack of Assurance of Sterility: environmental monitoring failure.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Class I - Dangerous
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class I - Dangerous
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Class I - Dangerous
Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class I - Dangerous
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
Novartis Pharmaceuticals
Class I - Dangerous
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Class I - Dangerous
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Lack of Assurance of Sterility
Class I - Dangerous
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class I - Dangerous
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Class I - Dangerous
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Class I - Dangerous
Lack of Assurance of Sterility
QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Microbial contamination of non-sterile products.
TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Class I - Dangerous
Lack of Assurance of Sterility