Class III · Low risk
Dextroamphetamine Saccharate
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
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 III · Low risk
Montelukast Sodium Tablets
Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).
Class I · High risk
MAXILOSS Weight Advanced
Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
Class II · Moderate risk
0.9% Sodium Chloride Irrigation
Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
Class II · Moderate risk
Pantoprazole Sodium Delayed Release Tablets USP
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
Class II · Moderate risk
Meprobamate
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Class II · Moderate risk
Meprobamate
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Class II · Moderate risk
CLONAZEPAM ORALLY DISINTERGRATING Tablets
Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
Class II · Moderate risk
Ciprofloxacin Tablets USP
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
Class III · Low risk
buPROPion Hydrochloride Extended Release Tablets
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Class II · Moderate risk
Benjamins Infants Gripe Mixture
CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.
Class III · Low risk
Tev-Tropin
Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
Class III · Low risk
Calcium Gluconate Injection
Labeling: Missing label
Class I · High risk
Vistide (cidofovir)
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
Class II · Moderate risk
Daytrana (methylphenidate)
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Class III · Low risk
Suprax (cefixime for oral suspension)
Discoloration; Product may not meet specifications for color description once reconstituted.
Class II · Moderate risk
ZoDen PD
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
ZoDen DM Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Z-Dex Syrup
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Z-Dex Pediatric Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Trigofen DM Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Trigofen Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
Tri-Dex PE
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
TL-Hist PD Drops
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
TL Hist DM
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.