Precision Dose Inc. recalls Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per t…

Recall date

September 25, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0057-2018

FDA classification

Class III

Brand / firm

Precision Dose Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

Subpotent Drug: low out of specification results.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.