Complete FDA and NHTSA recall records dated in April 2013.
These records include useful source details for the selected month.
Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
Chemical contamination: emission of strong odor after package was opened.
Chemical contamination: emission of strong odor after package was opened.
Chemical contamination: emission of strong odor after package was opened.
Chemical contamination: emission of strong odor after package was opened.
Chemical contamination: emission of strong odor after package was opened.
Chemical contamination: emission of strong odor after package was opened..
Chemical contamination: emission of strong odor after package was opened..
Chemical contamination: emission of strong odor after package was opened
Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of…
Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction,…
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to…
Chemical contamination: emission of strong odor after package was opened..
Chemical contamination: emission of strong odor after package was opened.
Discoloration; Product may not meet specifications for color description once reconstituted.
Chemical contamination: emission of strong odor after package was opened.
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant…
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
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.
