Complete FDA and NHTSA recall records dated in April 2013.
These records include useful source details for the selected month.
Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
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…
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
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.
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
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,…
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.
Subpotent; 22 month stability timepoint
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
