Precision Dose Recalls Carbamazepine Oral Suspension Due to Carton Labeling Error
Precision Dose Inc. is recalling Carbamazepine Oral Suspension because the product cartons list incorrect volume and NDC numbers, although the individual unit dose cups are correctly labeled.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error on the carton where the unit dose cups are correctly labeled, fitting the rubric for minor labeling errors.
Plain-English summary
Precision Dose Inc. is recalling Carbamazepine Oral Suspension, USP, 100 mg/5 mL, 5 mL Unit Dose Cups. The recall involves 480 unit dose cups from Lot #500326, which has an expiration date of 6/30/2018. The product is identified by NDC 68094-301-59.
The recall was initiated due to a labeling error. While the individual unit dose cups are correctly labeled, the outer product carton lists incorrect volume and NDC information. This discrepancy could potentially cause confusion regarding the product identity or quantity.
The affected product was distributed to Ohio and Connecticut. Consumers and healthcare providers who have this specific lot of Carbamazepine Oral Suspension should stop using it and contact their pharmacist or the recalling firm for instructions on how to return the product.
The recalled product
- 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.
- Manufacturer
- Precision Dose Inc.
- Category
- Drug — Anticonvulsant
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 500326
- Exp. 6/30/2018
Distribution
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