DrugApr 10, 2013
Palmer Natural Products NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 mg Aniracetam recall — FDA D-231-2013
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class IIFDA: TerminatedPalmer Natural Products
Monthly breakdown
2013 recalls by month
Select a month to review the recall records reported during that period.
2013 recalls — page 41
Records are ordered by the best available source date.
DrugApr 10, 2013
Palmer Natural Products Aniracetam & Choline capsules, 430mg Aniracetam 88mg Choline, a) 30 recall — FDA D-230-2013
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class IIFDA: TerminatedPalmer Natural Products
DrugApr 10, 2013
Hospira 0.9% Sodium Chloride Injection, USP, 50 mL recall — FDA D-243-2013
Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution…
Class IIFDA: TerminatedHospira Inc.
DrugApr 10, 2013
Palmer Natural Products Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 recall — FDA D-236-2013
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class IIFDA: TerminatedPalmer Natural Products
DrugApr 10, 2013
Palmer Natural Products Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count recall — FDA D-234-2013
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class IIFDA: TerminatedPalmer Natural Products
DrugApr 10, 2013
Dr Reddys Laboratories Tennessee Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL recall — FDA D-239-2013
Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.
Class IIFDA: TerminatedDr Reddys Laboratories Tennessee LLC
DrugApr 10, 2013
Palmer Natural Products Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 recall — FDA D-232-2013
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class IIFDA: TerminatedPalmer Natural Products
DrugApr 10, 2013
West-ward Pharmaceutical Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets recall — FDA D-242-2013
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Class IIFDA: TerminatedWest-ward Pharmaceutical Corp.
VehicleApr 9, 2013
Southeast Toyota Distributors labels recall — NHTSA campaign 13V123000
Southeast Toyota is recalling certain model year 2008 and 2010-2013 Toyota Tundra, 2010-2012 Rav4, 2012 Toyota Sequoia, 2010-2011 Toyota Corolla, 2010-2011 Toyota Camry and Camry Hybrid,…
labelsSoutheast Toyota Distributors, LLC
DrugApr 3, 2013
CareFusion 213 Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 recall — FDA D-227-2013
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Class IIFDA: TerminatedCareFusion 213, LLC
DrugApr 3, 2013
CareFusion 213 SEPP 2% Iodine Tincture USP recall — FDA D-225-2013
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Class IIFDA: TerminatedCareFusion 213, LLC
DrugApr 3, 2013
PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG recall — FDA D-222-2013
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Class IIFDA: TerminatedPhysicians Total Care, Inc.
DrugApr 3, 2013
CareFusion 213 FREPP/SEPP Kit containing 1 FREPP recall — FDA D-229-2013
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Class IIFDA: TerminatedCareFusion 213, LLC
DrugApr 3, 2013
Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle recall — FDA D-202-2013
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Class IIFDA: TerminatedZydus Pharmaceuticals USA Inc.
DrugApr 3, 2013
TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED recall — FDA D-219-2013
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Class IIIFDA: TerminatedPfizer Inc.
DrugApr 3, 2013
PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG recall — FDA D-221-2013
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Class IIFDA: TerminatedPhysicians Total Care, Inc.
DrugApr 3, 2013
CareFusion 213 SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators recall — FDA D-224-2013
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Class IIFDA: TerminatedCareFusion 213, LLC
DrugApr 3, 2013
Propofol Injectable Emulsion, 1% recall — FDA D-223-2013
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Class IIFDA: TerminatedHospira Inc.
DrugApr 3, 2013
L. Perrigo Co PE Daytime Cold/Flu LiqGel, Multi Symptom Relief recall — FDA D-216-2013
Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.
Class IIIFDA: TerminatedL. Perrigo Co.
DrugApr 3, 2013
Hill Dermaceuticals Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL) recall — FDA D-218-2013
Subpotent; 22 month stability timepoint
Class IIIFDA: TerminatedHill Dermaceuticals, Inc.
DrugApr 3, 2013
Ciprofloxacin Tablets USP, 500 mg, 100-count bottle recall — FDA D-220-2013
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
Class IIFDA: TerminatedWest-ward Pharmaceutical Corp.
DrugApr 3, 2013
CareFusion 213 Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 recall — FDA D-228-2013
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Class IIFDA: TerminatedCareFusion 213, LLC
DrugApr 3, 2013
CareFusion 213 SEPP 10% Povidone Iodine Solution USP recall — FDA D-226-2013
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Class IIFDA: TerminatedCareFusion 213, LLC
DrugMar 27, 2013
Watson Laboratories ZARAH Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg recall — FDA D-205-2013
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Class IIFDA: TerminatedWatson Laboratories Inc.
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.