Class II · Moderate risk
Clindamycin Phosphate USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class II · Moderate risk
Celecoxib USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Calcipotriene BP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Baclofen USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Anastrozole USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Amitriptyline HCl USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class I · High risk
Hydromorphone
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class I · High risk
Hydromorphone
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class III · Low risk
BonaDur For Men
CGMP Deviations: not manufactured according to current good manufacturing practices.
Class III · Low risk
Fluoxetine Tablets USP
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Class II · Moderate risk
100 mcg / mL Phenylephrine HCl
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Class II · Moderate risk
0.2% Ropivacaine HCI
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Class II · Moderate risk
15 units Oxytocin added to 0.9% Sodium Chloride Injection
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Class III · Low risk
Azelastine HCl Nasal Solution
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
Class III · Low risk
Klonopin (clonazepam)
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
Class III · Low risk
Metformin Hydrochloride Tablets
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Class III · Low risk
NORCO (Hydrocodone Bitartrate and Acetaminophen)
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Class II · Moderate risk
VELCADE (bortezomib)
Defective Container: Confirmed reports of loose vial crimps.
Class III · Low risk
Fentanyl Transdermal System
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Fentanyl Transdermal System. 75 mcg/h
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Fentanyl Transdermal System
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Fentanyl Transdermal System. 25 mcg/h
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Atorvastatin Calcium Tablets 40 mg
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk
Atorvastatin Calcium Tablets 20 mg
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk
Atorvastatin Calcium Tablets 10 mg
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability