Class II · Moderate risk
Paroxetine HCL Controlled-Release Tablets 25 mg
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
FDA drug recalls in 2014
Every FDA drug recall initiated in 2014, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,309 recalls, newest first.
Class II · Moderate risk
PAXIL (Paroxetine HCL)
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
Paroxetine HCL Controlled-Release Tablets 12.5 mg
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
INDOMETHACIN Capsules USP
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Class II · Moderate risk
INDOMETHACIN Capsules USP
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Class II · Moderate risk
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Class II · Moderate risk
ParaGard T 380A - Intrauterine Copper Contraceptive
Non-sterility: due to a failed sterility test
Class III · Low risk
Risperidone Oral Solution
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Class II · Moderate risk
Ranitidine Tablets USP
Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.
Class II · Moderate risk
Polidocanol 3% Solution
Presence of Particulate Matter
Class III · Low risk
Polidocanol 1% Solution
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Class III · Low risk
Papaverine 60 mg
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Class II · Moderate risk
Phosphatidylcholine Solution for Injection
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Class I · High risk
VPRIV¿ (velaglucerase alfa for injection)
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Class I · High risk
REUMOFAN PLUS Tablets
Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.
Class II · Moderate risk
Metformin Hydrochloride Tablets USP 1000 mg
Defective container: Product distributed without inner seal on bottles.
Class II · Moderate risk
Metformin Hydrochloride Tablets USP 500 mg
Defective container: Product distributed without inner seal on bottles.
Class II · Moderate risk
Perrigo
Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml.
Class II · Moderate risk
Lupron Depot
Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.
Class II · Moderate risk
Lupron Depot
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Class II · Moderate risk
Lupron Depot-Ped
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Class II · Moderate risk
Lupron Depot
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Class II · Moderate risk
Lupron Depot
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.