AMOXICILLIN AND CLAVULANATE POTASSIUM

Generic: AMOXICILLIN AND CLAVULANATE POTASSIUM

Sandoz IncManufacturer

ORALRoute

AMOXICILLINActive Substance

2005-08-23Original Approval

AMOXICILLIN AND CLAVULANATE POTASSIUM is FDA application ANDA065189, sponsored by SANDOZ. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2013-04-18

Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only.

Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg

Class II2022-04-13

Amoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0781-2613-01

cGMP deviations: Temperature abuse

Class III2016-11-04

Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceu

Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength

Class II2016-06-24

Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited

Superpotent drug: Out of specification test result for assay during stability testing.

Class II2022-01-26

AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage condi

Class II2022-01-26

AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage condi

Class III2017-04-26

Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria

Subpotent Drug; Clavulanic Acid

Class III2013-04-26

Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)

Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powd

Class III2013-06-18

Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73

Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin po

AMOXICILLIN AND CLAVULANATE POTASSIUM

Recalls

Top Reported Reactions