FDA recall D-0440-2017

Product

Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73

Reason for recall

Subpotency: due to a low, out of specification test result for assay during stability testing.

Distribution

United States and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-12-21

Report date

2017-02-01

Termination date

2018-02-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0440-2017