Class II · Moderate risk Terminated
Medi-Stat Foam
Reason Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Equi-Soft Foam
Reason Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
Class II · Moderate risk Terminated
INFed
Reason Failed Stability Specification: out of specification for iron content.
Class II · Moderate risk Terminated
Clopidogrel Tablets
Reason Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Class II · Moderate risk Terminated
Antacid Tablets
Reason Presence of foreign substance: Product found to contain metal particles.
Class II · Moderate risk Terminated
Curaplex Epi Kit NOT FOR IV USE
Reason Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
Class II · Moderate risk Terminated
Curaplex Epi Safe Kit
Reason Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
Class II · Moderate risk Terminated
curaplex Epi Safe Kit
Reason Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
Class II · Moderate risk Terminated
curaplex Epi Safe Administration and Training Kits
Reason Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
Class II · Moderate risk Terminated
IRBESARTAN Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Class II · Moderate risk Terminated
IRBESARTAN Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Class II · Moderate risk Terminated
IRBESARTAN Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Class II · Moderate risk Terminated
Isosorbide Dinitrate Tablets
Reason Cross Contamination with Other Products
Class II · Moderate risk Terminated
Isosorbide Dinitrate Tablets
Reason Cross Contamination with Other Products
Class II · Moderate risk Terminated
Isosorbide Dinitrate Tablets
Reason Cross Contamination with Other Products
Class II · Moderate risk Terminated
Isosorbide Dinitrate Tablets
Reason Cross Contamination with Other Products
Class II · Moderate risk Terminated
curaplex Epi Safe Administration and Training Kits # 8600-01100…
Reason Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 expired on December 2018, but the outer kit label has an expiration date of January 2020. In addition, device component (syringe) may lack 510(k) clearance.
Class II · Moderate risk Terminated
Bevacizumab 2.5 Mg/0.1ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Omnipaque
Reason Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
Class II · Moderate risk Terminated
Westminster Irbesartan Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Class II · Moderate risk Terminated
Westminster Irbesartan Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Class II · Moderate risk Terminated
Westminster Irbesartan Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Class II · Moderate risk Terminated
GSMS Irbesartan Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Terminated
GSMS Irbesartan Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Terminated
GSMS Irbesartan Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.