Class II · Moderate risk Terminated
fas.TRACT Coagulative Hemostatic Gel
Reason cGMP violations noted during the firm's most recent inspection.
FDA Drug Recalls
17,898 recalls, newest first
Class I · High risk Terminated
Sodium Chloride Injection
Reason Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
Class I · High risk Terminated
Sodium Chloride Injection
Reason Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
Class II · Moderate risk Terminated
Quetiapine Tablets USP 400 mg
Reason Presence of Foreign Substance; metal shard found in tablet
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.
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 III · Low risk Terminated
Nitrofurantoin Capsules USP
Reason Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."
Class II · Moderate risk Terminated
INFed
Reason Failed Stability Specification: out of specification for iron content.
Class III · Low risk Terminated
ERBITUX CETUXIMAB Injection
Reason Labeling: Missing label; potential for missing primary container label on the vial.
Class III · Low risk Terminated
Nitrofurantoin Monohydrate/Macrocrystals capsules
Reason Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
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 III · Low risk Terminated
Amitiza
Reason Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Class III · Low risk Terminated
Megestrol Acetate Oral Suspension
Reason Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Class II · Moderate risk Terminated
Antacid Tablets
Reason Presence of foreign substance: Product found to contain metal particles.
Class I · High risk Terminated
puriton EYE RELIEF DROPS
Reason Non-Sterility: Product manufactured under non-sterile production conditions.
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 III · Low risk Terminated
Nitrofurantoin Capsules
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