Class I - Dangerous
Out of Specification for active ingredient
💊
Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Out of Specification for active ingredient
Class I - Dangerous
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class I - Dangerous
Out of Specification for active ingredient
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
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.
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
Dercher Enterprises, Inc.
Class I - Dangerous
cGMP Deviations
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