FDA recall D-0013-2021

Product

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

Reason for recall

CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

Distribution

Nationwide in the U.S. and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2020-08-24

Report date

2020-09-16

Termination date

2021-12-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0013-2021