West-ward Recalls Carisoprodol Tablets for Missing C-IV Labeling
West-ward Pharmaceutical Corp. is recalling 1,763 bottles of Carisoprodol Tablets, 350 mg, because they lack the required C-IV imprint on the label.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling defect rather than a physical hazard.
Plain-English summary
West-ward Pharmaceutical Corp. is recalling 1,763 bottles of Carisoprodol Tablets, USP, 350 mg (NDC 0143-1176-01). The affected product is identified by Lot # 69160A and was distributed nationwide.
The recall was initiated because the product was not relabeled with the required "C-IV" imprint. On December 12, 2011, the DEA published a final rule making this product a schedule IV controlled substance, requiring the specific labeling for products distributed after the June 11, 2012 deadline.
This is a Class III recall, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for this specific lot and contact the manufacturer or their supplier for instructions on return or disposal.
The recalled product
- Product
- Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01.
- Manufacturer
- West-ward Pharmaceutical Corp.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,763
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 (1)
- Lot #: 69160A
Distribution
Distributed nationwide across the United States.
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