Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot..
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
THE COMPOUNDING SHOP
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class I - Dangerous
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class I - Dangerous
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL
THE COMPOUNDING SHOP
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration,
Nora Apothecary and Alternative Therapies
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration,
Nora Apothecary and Alternative Therapies
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India
Mylan Pharmaceuticals
Class I - Dangerous
Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration,
Nora Apothecary and Alternative Therapies
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
Nora Apothecary and Alternative Therapies
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration,
Nora Apothecary and Alternative Therapies
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class I - Dangerous
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label