Class II · Moderate risk
Lloyd Thyro-Tab 0.112 mg.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
FDA drug recalls in 2013
Every FDA drug recall initiated in 2013, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
2,085 recalls, newest first.
Class II · Moderate risk
Lloyd Thyro-Tab 0.100 mg.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Class II · Moderate risk
Lloyd Thyro-Tab 0.088 mg.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Class II · Moderate risk
Levothroid
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Class II · Moderate risk
Lloyd Thyro-Tab 0.075 mg.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Class II · Moderate risk
Levothroid
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Class II · Moderate risk
Lloyd Thyro-Tab 0.050 mg.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Class II · Moderate risk
Levothroid
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Class I · High risk
ROCK-IT MAN capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates
Class II · Moderate risk
Methylcobalamin
Lack of Assurance of Sterility; reports of adverse events after injection
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened..
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened..
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Chemical contamination: emission of strong odor after package was opened..
Class III · Low risk
Lorazepam
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
Class II · Moderate risk
Verapamil Injection
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Vancomycin Ophthalmic PF
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance