CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Prescription Drugs
💊 Drugs • 12,141 recalls
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01
Teva Pharmaceuticals USA
CGMP Deviation; cotton coil is missing in some packaged bottles
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146, Mfg By: Novartis Consumer Health, Parsippany, NJ 07054, NDC 54868-5965-00
Physicians Total Care
Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because the lot number and expiration date on the tube may not be legible.
Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60
Legacy Pharmaceutical Packaging
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
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.
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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..
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
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
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
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..
Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
Nora Apothecary and Alternative Therapies
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.