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.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Subpotent Drug: The products were below specification for potency at the expiry stability point.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Subpotent Drug: The products were below specification for potency at the expiry stability point.
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.
