Precision Dose Inc. recalls Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL…
- Recall date
- July 5, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1037-2017
- FDA classification
- Class II
- Brand / firm
- Precision Dose Inc.
- Sold / distributed
- OH and CT
Why it was recalled
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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