Class I - Dangerous
Lack of Assurance of Sterility
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Prescription Drugs
💊 Drugs • 12,141 recalls
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52
Dr. Reddy's Laboratories
Class I - Dangerous
Lack of Assurance of Sterility: Leaking vials
Class I - Dangerous
Lack of Assurance of Sterility
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
Hikma Injectables USA
Class I - Dangerous
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Failed Release Testing: Out of specification for particulate matter test.
Class I - Dangerous
Subpotent product in addition to having out-of-specification results for impurities.
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Preferred Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class I - Dangerous
Lack of Assurance of Sterility.
Class I - Dangerous
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class I - Dangerous
Presence of Particulate Matter: Potential for black particulates in the drug product.
Class I - Dangerous
Marketed Without An Approved NDA/ANDA
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 foreign substance: plastic-like substance.
Class I - Dangerous
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
Dr. Reddy's Laboratories
Class I - Dangerous
Sub-potent Drug; powder discoloration associated with decreased potency
Class I - Dangerous
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Out of specification for assay