FDA recall D-0165-2024

Product

AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73

Reason for recall

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

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2022-01-26

Report date

2024-01-03

Termination date

2024-09-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0165-2024