Class I - Dangerous
Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).
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Prescription Drugs
💊 Drugs • 12,141 recalls
CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523
Dr. Reddy's Laboratories
Class I - Dangerous
Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.
Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS
Vital Care Compounder
Class I - Dangerous
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01
Aidarex Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ 08807. NDC: 0187-4220-10.
Valeant Pharmaceuticals North America
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Class I - Dangerous
Discoloration: presence of scuffing marks on tablets.
Class I - Dangerous
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada
Attix Pharmaceuticals
Class I - Dangerous
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10
Virtus Pharmaceuticals
Class I - Dangerous
Chemical Contamination: Bottles may contain broken dessicants
VERMOX Tablets 500 mg, 1-count box, UPC 501109900596
Profarma Distributors
Class I - Dangerous
CGMP Deviations
tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057
Profarma Distributors
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619
Profarma Distributors
Class I - Dangerous
CGMP Deviations
tabcin NOCHE; Capsules,12-count box, UPC 501008485033
Profarma Distributors
Class I - Dangerous
CGMP Deviations
VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30
Virtus Pharmaceuticals
Class I - Dangerous
Defective delivery system: Softgel capsules are leaking.
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10.
Valeant Pharmaceuticals North America
Class I - Dangerous
Failed Impurities/Degradation Specifications
Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.
Galderma Laboratories, L.P.
Class I - Dangerous
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 68682-409-10.
Valeant Pharmaceuticals North America
Class I - Dangerous
Failed Impurities/Degradation Specifications