FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated Aug 23, 2013

Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA

Reason Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one…

South Coast Specialty Compounding, Inc. D-1027-2013

Class II · Moderate risk Terminated Aug 23, 2013

Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For Slow IV Administration…

Reason Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame…

South Coast Specialty Compounding, Inc. D-1026-2013

Class II · Moderate risk Terminated Aug 23, 2013

Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA

Reason Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame…

South Coast Specialty Compounding, Inc. D-1025-2013

Class II · Moderate risk Terminated Aug 23, 2013

Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.

Reason Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported…

Creative Compounds D-1019-2013

Class II · Moderate risk Terminated Aug 17, 2013

Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 ---…

Reason Failed dissolution specifications; 18 month CRT

Amneal Pharmaceuticals of New York, LLC. NDC 65162-212-11 D-66014-001

Class II · Moderate risk Terminated Aug 16, 2013

Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake…

Reason Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.

Hospira Inc. NDC 0409-3213-12 D-927-2013

Class II · Moderate risk Terminated Aug 14, 2013

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton…

Reason Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample…

Hospira Inc. NDC 0409-4699-30 D-932-2013

Class II · Moderate risk Terminated Aug 14, 2013

Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges…

Reason Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental…

Novocol Pharmaceutical of Canada D-923-2013

Class II · Moderate risk Terminated Aug 13, 2013

CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11

Reason Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.

Teva Pharmaceuticals USA, Inc. NDC 0703-3249-11 D-928-2013

Class II · Moderate risk Terminated Aug 12, 2013

Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01

Reason Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.

Hospira, Inc. NDC 0409-3795-01 D-926-2013

Class II · Moderate risk Terminated Aug 9, 2013

All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613

Reason Lack of Assurance of Sterility

Specialty Compounding, LLC D-0231-2015

Class II · Moderate risk Terminated Aug 8, 2013