FDA-Drug2017-11-08Class III

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.

Precision Dose Inc.
Hazard

Subpotent Drug: low out of specification results.

Sold states
Nationwide in the USA
Affected count
801 cases
Manufactured in
722 Progressive Ln, N/A, South Beloit, IL, United States
Products
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.

Official notice

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

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