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.
- 2013-07-03FDA-DrugHospira Inc.Class II5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- 2013-07-03FDA-DrugHospira Inc.Class II5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- 2013-07-03FDA-DrugHospira Inc.Class II0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- 2013-07-03FDA-DrugHospira Inc.Class II70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- 2013-07-03FDA-DrugHospira Inc.Class II0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- 2013-07-03FDA-DrugHill Dermaceuticals, Inc.Class IIIDerma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.
Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- 2013-06-26FDA-DrugPharmacia & Upjohn LLCClass IICleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, Rx Only, For Intravenous Use Only, Use Only with the ADD-Vantage diluent container, Distributed by Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017, NDC a) 0009-3124-03 and b) 0009-3447-03
Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.
- 2013-06-26FDA-DrugHospira Inc.Class II0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
- 2013-06-26FDA-DrugPfizer IncClass IIINorpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017.
Failed Dissolution Specification
- 2013-06-26FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIActiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116
Failed Dissolution Specification; during stability testing
- 2013-06-26FDA-DrugSagent Pharmaceuticals IncClass IIVECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
- 2013-06-26FDA-DrugFaria Limited LLC dba Sheffield PharmaceuticalsClass IIIDr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First Aid Antibiotic Ointment, Net Wt. 0.33oz (9g)
Failed Stability Specifications: Unable to meet shelf life expiry.
- 2013-06-26FDA-DrugHi-Tech Pharmacal Co., Inc.Class IIIHydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
Subpotent; 24 month stability test station
- 2013-06-26FDA-DrugMission Pharmacal CoClass IIISodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
- 2013-06-19FDA-DrugAdvance Pharmaceutical IncClass IRugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA 30097 UPC 0 0536-5890-013
Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
- 2013-06-19FDA-DrugOLAAX InternationalClass IMAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL
Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
- 2013-06-19FDA-DrugActavisClass IIIFentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.
Failed Impurities/Degradation Specifications
- 2013-06-19FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIIAmoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)
Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
- 2013-06-19FDA-DrugSandoz IncorporatedClass IICefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box)
Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.
- 2013-06-12FDA-DrugPhysicians Total Care, Inc.Class IIIVoltaren 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
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.
- 2013-06-12FDA-DrugPentec HealthClass IIBaxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
- 2013-06-12FDA-DrugPentec HealthClass IIBaxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
- 2013-06-12FDA-DrugPentec HealthClass IIBaxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
- 2013-06-12FDA-DrugPentec HealthClass IIProplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
- 2013-06-12FDA-DrugPentec HealthClass IIProplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
- 2013-06-12FDA-DrugPentec HealthClass IIProplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
- 2013-06-12FDA-DrugPentec HealthClass IIProplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
- 2013-06-12FDA-DrugPentec HealthClass IIProplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
- 2013-06-12FDA-DrugPentec HealthClass IIProplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
- 2013-06-12FDA-DrugPentec HealthClass IIProplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
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