Complete FDA and NHTSA recall records dated in 2013, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products
cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol…
Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.
Presence of foreign substance: One lot of the product may contain black foreign particles
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.
CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.
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.
