Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.

FDA recall notice · announced August 9, 2017 · Precision Dose

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.

Reason for recall

Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.

Notes

Distribution: OH and CT
Lot/code information: Lot #: 500326, Exp. 6/30/2018
Quantity: 480 (5mL) unit dose cups
Status: Terminated
Products in this recall event:
- Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59. (D-1037-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.