Donnatal Extentabs Recalled for Incorrect Expiration Date Labeling
West-ward Pharmaceutical is recalling 1,258 bottles of Donnatal Extentabs because the bottles are labeled with an expiration date of April 2015 instead of the correct April 2013.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 labeling error regarding the expiration date, which fits the criteria for moderate severity involving minor labeling errors.
Plain-English summary
West-ward Pharmaceutical Corp. is recalling 1,258 bottles of Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottles (NDC # 66213-421-10). The product is prescription-only and was manufactured for PBM Pharmaceuticals, Inc.
The recall was initiated due to a labeling error. The bottles are labeled with an expiration date of April 2015, but the correct expiration date is April 2013. The affected lot number is 68864.
The product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot and expiration date. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942.
- Manufacturer
- West-ward Pharmaceutical Corp.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,258
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 # 68864
- exp 04/13
Distribution
Distributed nationwide across the United States.
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