PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: November 8, 2017 Initiated: September 25, 2017 #D-0057-2018

Product Description

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.

Details

Recalling Firm
Precision Dose Inc.
Units Affected
801 cases
Distribution
Nationwide in the USA
Location
South Beloit, IL

Frequently Asked Questions

What product 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.. Recalled by Precision Dose Inc.. Units affected: 801 cases.
Why was this product recalled?
Subpotent Drug: low out of specification results.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 8, 2017. Severity: Low. Recall number: D-0057-2018.