DrugFeb 13, 2013
Bracco Diagnostic Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL recall — FDA D-157-2013
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Class IFDA: TerminatedBracco Diagnostic Inc.
Monthly breakdown
2013 recalls by month
Select a month to review the recall records reported during that period.
2013 recalls — page 44
Records are ordered by the best available source date.
DrugFeb 13, 2013
Watson Pharmaceuticals Taztia XT recall — FDA D-145-2013
Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%).
Class IIFDA: TerminatedWatson Pharmaceuticals
DrugFeb 13, 2013
Actelion Pharmaceuticals U.S Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile recall — FDA D-143-2013
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Class IIIFDA: TerminatedActelion Pharmaceuticals U.S., Inc.
DrugFeb 13, 2013
Globe All Wellness SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles recall — FDA D-148-2013
Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making…
Class IFDA: TerminatedGlobe All Wellness, LLC
DrugFeb 13, 2013
Ascend Therapeutics EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps recall — FDA D-146-2013
Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
Class IIIFDA: TerminatedAscend Therapeutics Inc.
DrugFeb 6, 2013
Schering-Plough Products Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per recall — FDA D-139-2013
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Class IIFDA: TerminatedSchering-Plough Products, LLC
DrugFeb 6, 2013
Vintage Pharmaceuticals LLC DBA Qualitest Hydrocodone bitartrate and acetaminophen Tablets recall — FDA D-138-2013
Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
Class IFDA: TerminatedVintage Pharmaceuticals LLC DBA Qualitest…
DrugJan 30, 2013
West-ward Pharmaceutical Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg recall — FDA D-132-2013
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
Class IIFDA: TerminatedWest-ward Pharmaceutical Corp.
DrugJan 30, 2013
Axcentria Pharmaceuticals Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL) recall — FDA D-134-2013
Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the…
Class IIIFDA: TerminatedAxcentria Pharmaceuticals LLC
DrugJan 30, 2013
Genentech Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg) recall — FDA D-135-2013
Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain…
Class IFDA: TerminatedGenentech Inc.
DrugJan 30, 2013
West-ward Pharmaceutical PredniSONE Tablets, USP, 20 mg recall — FDA D-133-2013
Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.
Class IIFDA: TerminatedWest-ward Pharmaceutical Corp.
DrugJan 30, 2013
West-ward Pharmaceutical Propylthiouracil Tablets, USP, 50 mg recall — FDA D-131-2013
Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.
Class IIFDA: TerminatedWest-ward Pharmaceutical Corp.
DrugJan 30, 2013
West-ward Pharmaceutical Lisinopril Tablets, USP 40 mg recall — FDA D-130-2013
Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in…
Class IIFDA: TerminatedWest-ward Pharmaceutical Corp.
DrugJan 30, 2013
Belmora Flanax recall — FDA D-136-2013
Defective Container: Product lacks tamper evident breakaway band on cap.
Class IIIFDA: TerminatedBelmora LLC
DrugJan 23, 2013
Upsher Smith Laboratories Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic recall — FDA D-127-2013
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
Class IIIFDA: TerminatedUpsher Smith Laboratories, Inc.
DrugJan 23, 2013
L. Perrigo Co Prednisone tablets, USP, 10mg recall — FDA D-125-2013
Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with…
Class IIFDA: TerminatedL. Perrigo Co.
DrugJan 23, 2013
James G. Cole I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O recall — FDA D-129-2013
Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and…
Class IIFDA: TerminatedJames G. Cole, Inc.
VehicleJan 16, 2013
Southeast Toyota Distributors sensor/control module-inactive recall — NHTSA campaign 13V014000
Southeast Toyota Distributors, LLC (SET) is recalling certain models interspersed through model years 2009 through 2013 as follows: model year 2009-2012 Tacoma, 4Runner, Camry, Camry…
sensor/control module-inactiveSoutheast Toyota Distributors, LLC
DrugJan 9, 2013
Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle recall — FDA D-107-2013
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Class IIFDA: TerminatedAbbott Laboratories
DrugJan 9, 2013
New England Compounding Center Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF recall — FDA D-116-2013
Lack of Assurance of Sterility
Class IIFDA: TerminatedNew England Compounding Center
DrugJan 9, 2013
New England Compounding Center Betamethasone Sodium Phosphate 6 mg/mL P Injection recall — FDA D-113-2013
Lack of Assurance of Sterility
Class IIFDA: TerminatedNew England Compounding Center
DrugJan 9, 2013
New England Compounding Center Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and recall — FDA D-121-2013
Lack of Assurance of Sterility
Class IIFDA: TerminatedNew England Compounding Center
DrugJan 9, 2013
New England Compounding Center Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL recall — FDA D-124-2013
Lack of Assurance of Sterility
Class IIFDA: TerminatedNew England Compounding Center
DrugJan 2, 2013
Lloyd Inc. of Iowa Thyro-Tab 0.050 mg recall — FDA D-100-2013
Subpotent; 9-month stability interval
Class IIFDA: TerminatedLloyd Inc. of Iowa
About the 2013 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.