Class III · Low risk
Novartis Lamisil AT Cream
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
FDA Drug Recalls
1,969 recalls, newest first
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.
Class III · Low risk
PE Daytime Cold/Flu LiqGel
Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.
Class III · Low risk
Femhrt (norethindrone acetate and ethinyl estradiol)
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Class III · Low risk
Jevantique
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Class III · Low risk
Femhrt (norethindrone acetate and ethinyl estradiol)
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Class II · Moderate risk
Amoxicillin for Oral Suspension
Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.
Class II · Moderate risk
METRONIDazole Injection
Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
Class II · Moderate risk
ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
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.
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.