FDA Drug Recalls

1,523 recalls · Class III, newest first

Class III · Low risk Terminated Oct 21, 2014

Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa…

Reason Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory…

Taro Pharmaceuticals U.S.A., Inc. NDC 51672-4005-3 D-0049-2015

Class III · Low risk Terminated Oct 20, 2014

Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, Powder, NET: 22 KG, Packaged in double plastic…

Reason cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.

Nanophase Technologies Corporation D-0238-2015

Class III · Low risk Terminated Oct 16, 2014

Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only…

Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Apotex Inc. NDC 60505-3621-3 D-0244-2015

Class III · Low risk Terminated Oct 16, 2014

Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only…

Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Apotex Inc. NDC 60505-3620-3 D-0243-2015

Class III · Low risk Terminated Oct 16, 2014

Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099…

Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Apotex Inc. NDC 60505-3619-3 D-0242-2015

Class III · Low risk Terminated Oct 16, 2014

Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099…

Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Apotex Inc. NDC 60505-3618-3 D-0241-2015

Class III · Low risk Terminated Oct 10, 2014

TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only…

Reason Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold…

Pfizer Inc. NDC 0008-1179-01 D-0235-2015

Class III · Low risk Terminated Oct 10, 2014

MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus…

Reason Subpotent; 6 month stability time point

American Health Packaging NDC 68084-149-01 D-0043-2015

Class III · Low risk Terminated Oct 2, 2014

candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan…

Reason Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone…

Sandoz, Inc NDC 0781-5938-92 D-0288-2015

Class III · Low risk Terminated Oct 2, 2014

Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC…

Reason Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point

Valeant Pharmaceuticals International NDC 16781-382-15 D-0026-2015

Class III · Low risk Terminated Oct 2, 2014

Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford…

Reason Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point

Valeant Pharmaceuticals International NDC 43478-270-15 D-0025-2015

Class III · Low risk Terminated Oct 1, 2014

Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India…

Reason Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.

Zydus Pharmaceuticals USA Inc NDC 68382-123-16 D-0257-2015

Class III · Low risk Terminated Sep 30, 2014

Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for…

Reason Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.

Gilead Sciences, Inc. NDC 61958-0701-1 D-0013-2015

Class III · Low risk Terminated Sep 24, 2014

BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India…

Reason Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.

Zydus Pharmaceuticals USA Inc D-0289-2015

Class III · Low risk Terminated Sep 18, 2014

E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM…

Reason Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.

Bracco Diagnostic Inc NDC 10361-793-01 D-0014-2015

Class III · Low risk Terminated Sep 11, 2014

MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15)…

Reason Subpotent; 6 month stability time point

Qualitest Pharmaceuticals NDC 0603-4593-21 D-1605-2014

Class III · Low risk Terminated Aug 25, 2014

Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only. Mfd. by: Taro Pharmaceutical Industries…

Reason Failed Content Uniformity Specifications.

Taro Pharmaceuticals U.S.A., Inc. D-1584-2014

Class III · Low risk Terminated Aug 21, 2014

Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research…

Reason Failed Impurity/Degradation Specification; high out of specification for CAD II degradant

Apotex Corp. NDC 60505-3759-9 D-1570-2014

Class III · Low risk Terminated Aug 20, 2014

CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005.

Reason Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.

ChiroNutraceutical LLC D-1569-2014

Class III · Low risk Terminated Aug 19, 2014

Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI…

Reason Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.

Perrigo Holland Inc D-1558-2014

Class III · Low risk Terminated Aug 19, 2014

Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured…

Reason Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.

Micro Labs Usa, Inc S NDC 42571-010-90 D-0246-2015

Class III · Low risk Terminated Aug 5, 2014

Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually…

Reason Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point

Akorn, Inc. NDC 17478-151-42 D-1571-2014

Class III · Low risk Terminated Jul 30, 2014

Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only, Distributed by…

Reason Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is…

Pfizer Inc. NDC 0009-3073-03 D-1537-2014

Class III · Low risk Terminated Jul 30, 2014

Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations…

Reason Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.

Novartis Pharmaceuticals Corp. NDC 0078-0436-05 D-1516-2014

Class III · Low risk Terminated Jul 28, 2014

OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories…

Reason Failed Stability Specifications: Out of specification result for preservative sodium benzoate.

Boehringer Ingelheim Roxane Inc D-1486-2014