Class I - Dangerous
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1
IntegraDose Compounding Services
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Lack of Sterility Assurance: Aseptic process simulation failure.
Class I - Dangerous
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Class I - Dangerous
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class I - Dangerous
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class I - Dangerous
Presence of Particulate Matter; identified as glass
Class I - Dangerous
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Class I - Dangerous
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Class I - Dangerous
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class I - Dangerous
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class I - Dangerous
Presence of Particulate Matter; identified as glass
Class I - Dangerous
Presence of Particulate Matter; identified as glass
Class I - Dangerous
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class I - Dangerous
Defective Container: powder may leak out of the pouch
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.
Lupin Pharmaceuticals
Class I - Dangerous
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01
Dr. Reddy's Laboratories
Class I - Dangerous
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15
Dr. Reddy's Laboratories
Class I - Dangerous
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Class I - Dangerous
Presence of Foreign Tablets/Capsules
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Fresenius Medical Care Holdings
Class I - Dangerous
Lack of Sterility Assurance