Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2014-03-26FDA-DrugMcKesson Packaging ServicesClass IIIVenlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10
Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
- 2014-03-26FDA-DrugPfizer Us Pharmaceutical GroupClass IIIAdvil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
- 2014-03-26FDA-DrugTraxx International CorpClass IIGuaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001
Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin.
- 2014-03-26FDA-DrugRX South LLC DBA RX3 PharmacyClass IIHydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831***
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
- 2014-03-26FDA-DrugBaxter Healthcare Corp.Class I0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
- 2014-03-26FDA-DrugBaxter Healthcare Corp.Class I5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38.
Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
- 2014-03-26FDA-DrugHospira Inc.Class IMarcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
- 2014-03-26FDA-DrugBaxter Healthcare Corp.Class IClinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04.
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
- 2014-03-26FDA-DrugBaxter Healthcare Corp.Class IClinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-1115-04.
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
- 2014-03-26FDA-DrugBaxter Healthcare Corp.Class IClinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04.
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
- 2014-03-19FDA-DrugPinnacle Biologics IncClass IIIPhotofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only. Manufactured for: Pinnacle Biologics, Inc. Bannockburn, IL 60015. NDC:76128-155-75
Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
- 2014-03-19FDA-DrugSpecialty Medicine Compounding Pharmacy, P.C.Class IDextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.
- 2014-03-19FDA-DrugMylan Institutional, Inc. (d.b.a. UDL Laboratories)Class IIICarisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20
Failed Impurity/degradation Specification
- 2014-03-19FDA-DrugCTV Best GroupClass IBEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bottle, Distributed by CTV Best Group Inc., P.O. Box 956452, Duluth, GA 30095.
Marketed without an Approved NDA/ANDA: Product contains an undeclared drug, sibutramine, making it an unapproved new drug.
- 2014-03-19FDA-DrugActavis Elizabeth LLCClass IIAlprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50
Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.
- 2014-03-19FDA-DrugFougera Pharmaceuticals Inc.Class IIITriamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
- 2014-03-12FDA-DrugMira Health Products Ltd.Class IMETHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone Labs, Boca Raton, FL
Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug
- 2014-03-12FDA-DrugMira Health Products Ltd.Class ISuper-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle mass, hardness and strength, Manufactured for Blackstone Labs Boca Raton, FL 33433.
Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug
- 2014-03-12FDA-DrugMira Health Products Ltd.Class IB-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count bottles, Manufactured for: Purity First Health Products, Inc. dba Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735
Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug
- 2014-03-12FDA-DrugFresenius Kabi USA, LLCClass IIHeparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11.
Subpotent; 18 month time point
- 2014-03-12FDA-DrugHospira Inc.Class IIBupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
- 2014-03-12FDA-DrugDr. Reddy's Laboratories, Inc.Class IIa) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed by Family Services Inc .10401 Monroe Road, Matthews, NC 28105 USA c) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 14 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS
Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.
- 2014-03-12FDA-DrugNatures Pharmacy & Compounding CenterClass IIVoriconazole 0.5mg/ml
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-03-12FDA-DrugNatures Pharmacy & Compounding CenterClass IIVoriconazole 0.5mg/ml
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-03-12FDA-DrugNatures Pharmacy & Compounding CenterClass IIVoriconazole 1% opthal
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-03-12FDA-DrugNatures Pharmacy & Compounding CenterClass IIVitamin D (Ergocalciferol) 800 u/ml
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-03-12FDA-DrugNatures Pharmacy & Compounding CenterClass IIVit A (olive oil) 0.1% opth.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-03-12FDA-DrugNatures Pharmacy & Compounding CenterClass IIVancomycin (fortified) 25mg/ml opth
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-03-12FDA-DrugNatures Pharmacy & Compounding CenterClass IITriamcinolone Acetonide 3mg/ml
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- 2014-03-12FDA-DrugNatures Pharmacy & Compounding CenterClass IITestosterone Cypionate 200mg/ml
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
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