FDA recall D-0057-2018

Product

Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.

Reason for recall

Subpotent Drug: low out of specification results.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-09-25

Report date

2017-11-08

Termination date

2018-04-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Beloit, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0057-2018