Class III · Low risk Terminated
Dextroamphetamine Saccharate
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
FDA Drug Recalls
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Class III · Low risk Terminated
Dextroamphetamine Saccharate
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk Terminated
Dextroamphetamine Saccharate
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets USP 750 mg
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk Terminated
Bupivacaine Hydrochloride in 8.25% Dextrose Injection
Reason Presence of particulate matter in solution - black and transparent particles
Class II · Moderate risk Terminated
metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals…
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk Terminated
metformin HCL ER 500 mg
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class III · Low risk Terminated
Desflurane
Reason DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.
Class I · High risk Terminated
HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL…
Reason Non-Sterility
Class I · High risk Terminated
Hydromorphone Hcl-Bupivacaine Hcl-Sufentanil Pf…
Reason Non-Sterility
Class I · High risk Terminated
MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe
Reason Non-Sterility
Class I · High risk Terminated
Sufentanil-Bupivacaine-Baclofen Pf 25mcg-12.5mg-750mcg/Ml…
Reason Non-Sterility
Class I · High risk Terminated
MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two…
Reason Non-Sterility
Class I · High risk Terminated
MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe
Reason Non-Sterility
Class I · High risk Terminated
HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL…
Reason Non-Sterility
Class I · High risk Terminated
MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL
Reason Non-Sterility
Class I · High risk Terminated
Hydromorphone Hcl-Bupivacaine Hcl-Clonidine HCL Pf Injectable 21…
Reason Non-Sterility
Class I · High risk Terminated
HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL…
Reason Non-Sterility
Class I · High risk Terminated
Fentanyl-Bupivacaine Hcl-Baclofen Pf Injectable 575mcg-18mg-6000mcg/Ml
Reason Non-Sterility
Class I · High risk Terminated
Fentanyl-Bupivacaine HCL Pf Injectable 3000mcg-12mg/Ml
Reason Non-Sterility
Class I · High risk Terminated
Bupivacaine Hcl-Lioresal Pf Injectable 7.5mg-1625mcg/Ml
Reason Non-Sterility
Class I · High risk Terminated
Bupivacaine Hcl-Baclofen Pf Injectable 40mg-4000mcg/Ml
Reason Non-Sterility
Class II · Moderate risk Terminated
Catapres
Reason An extraneous peak was observed for dissolution testing.
Class II · Moderate risk Terminated
Catapres
Reason An extraneous peak was observed for dissolution testing.